9 results
  • A Phase 3 Randomized Clinical Study of MK-4280A Coformulated Favezelimab MK-4280 plus Pembrolizumab MK-3475 Versus Physician's Choice Chemotherapy in PD-(L)1-Refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (KEYFORM-008). - NCT05508867

    Primary Objective: To compare MK-4280A to physicians choice chemotherapy with respect to PFS per Lugano response criteria by BICR Secondary Objectives: - To compare MK-4280A to physicians choice chemotherapy with respect to OS - To evaluate MK-4280A and physicians choice chemotherapy with respect to ORR per Lugano response criteria by BICR - To evaluate MK-4280A and physicians choice chemotherapy with respect to DOR per Lugano response criteria by BICR - To evaluate the safety and tolerability of MK-4280A

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    • Protocol Number:
      012315

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      GEMCITABINE BENDAMUSTINE Favezelimab (MK4280A)

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Matthew Matasar

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) that is 2-fluorodeoxyglucose-avid (FDG-avid).
    • Has relapsed (defined as disease progression after most recent therapy) or refractory (defined as failed to achieve CR or PR to most recent therapy) cHL and exhausted all available treatment options with known clinical benefit.
    • Has progressed on treatment with an anti-PD-(L)1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
    • Submits an archival (≤5 years) or newly obtained tumor tissue sample which has not been previously irradiated.

    Exclusion Criteria:

    • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy.
    • History of central nervous system (CNS) metastases or active CNS involvement.
    • Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
    • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
    • Has an active infection requiring systemic treatment.
    • History of hemophagocytic lymphohisticytosis.
    • Has an active seizure disorder that is not well controlled.
    • Has clinically significant (ie, active) cardiovascular disease.
    • Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
    • Received prior radiotherapy within 2 weeks of start of study intervention or radiation related toxicities requiring corticosteroids.
    • Has not adequately recovered from major surgical procedure.
    • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
    • History of human immunodeficiency virus (HIV).
    • Has had an allogeneic hematopoietic stem cell or solid organ transplantation within the last 5 years.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Monmouth Medical Center
    • Community Medical Center
    • Jersey City Medical Center
    • Rutgers Cancer Institute
  • A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-Oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma - NCT05675410

    1. To compare the PFS of a standard chemotherapy approach versus an IO therapy approach (brentuximab vedotin and nivolumab) in patients with newly diagnosed early stage cHL who have a rapid early response (RER) as determined by PET2 after 2 cycles of doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD) chemotherapy. 2. To compare the PFS of a standard chemotherapy approach versus an IO therapy approach (brentuximab vedotin and nivolumab) plus involved site radiation therapy (ISRT) in patients with newly diagnosed early stage cHL who have a slow early response (SER) as determined by PET2 after 2 cycles of ABVD chemotherapy

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    • Protocol Number:
      112305

    • Principal Investigator:
      Richard Drachtman M.D.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Brentuximab vedotin BLEOMYCIN VINBLASTINE ADRIAMYCIN DACARBAZINE Opdivo (Nivolumab)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Richard Drachtman M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patients must be 5 to 60 years of age at the time of enrollment
    • Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified [NOS]) with stage I or II disease
    • Patients must have bidimensionally measurable disease (at least one lesion with longest diameter >= 1.5 cm)
    • Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained
    • Pediatric patients (age 5-17 years) must have an upright posteroanterior (PA) chest X-ray (CXR) for assessment of bulky mediastinal disease. Adult patients must have either a CXR or CT chest
    • Patients >= 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2
    • Patients =< 17 years of age must have a Lansky performance score of >= 50
    • Pediatric patients (age 5-17 years): A serum creatinine based on age/gender as follows (within 7 days prior to enrollment):
    • 2 to < 6 years (age): 0.8 mg/dL (male), 0.8 mg/dL (female)
    • 6 to < 10 years (age): 1 mg/dL (male), 1 mg/dL (female)
    • 10 to < 13 years (age): 1.2 mg/dL (male), 1.2 mg/dL (female)
    • 13 to < 16 years (age): 1.5 mg/dL (male), 1.4 mg/dL (female)
    • >= 16 years (age): 1.7 mg/dL (male), 1.4 mg/dL (female) OR a 24 hour urine creatinine clearance >= 50 mL/min/1.73 m^2 (within 7 days prior to enrollment) OR a glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2 (within 7 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
    • Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility
    • For adult patients (age 18 years or older) (within 7 days prior to enrollment): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight
    • Total bilirubin =< 2 x upper limit of normal (ULN) (within 7 days prior to enrollment)
    • Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
    • Aspartate aminotransferase (AST) =< 3 x ULN (within 7 days prior to enrollment)
    • Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
    • Alanine aminotransferase (ALT) =< 3 x ULN (within 7 days prior to enrollment)
    • Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
    • Shortening fraction of >= 27% by echocardiogram (ECHO), multigated acquisition scan (MUGA), or functional cardiac imaging scan (within 7 days prior to enrollment) or ejection fraction of >= 50% by radionuclide angiogram, ECHO, MUGA, or cardiac imaging scan (within 7 days prior to enrollment)
    • Diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% of predicted value as corrected for hemoglobin by pulmonary function test (PFT) (within 7 days prior to enrollment). If unable to obtain PFTs, the criterion is: a pulse oximetry reading of > 92% on room air
    • Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
    • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

    Exclusion Criteria:

    • Patients with nodular lymphocyte predominant Hodgkin lymphoma
    • Patients with a history of active interstitial pneumonitis or interstitial lung disease
    • Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients
    • Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and/or absorption of pills
    • Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to > 10 mg daily prednisone for patients >= 18 years or > 0.5 mg/kg [up to 10 mg/day] for patients < 18 years) or other immunosuppressive medications within 14 days prior to enrollment
    • Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment. Inhaled or topical steroids, and adrenal replacement doses (=< 10 mg daily for patients >= 18 years or =< 0.5 mg/kg [up to 10 mg/day] prednisone equivalents) are permitted in the absence of active autoimmune disease
    • Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1
    • Patients with peripheral neuropathy > grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome
    • Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
    • Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL
    • Prior solid organ transplant
    • Prior allogeneic stem cell transplantation
    • Live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, bacillus calmette guerin [BCG], oral polio vaccine, and oral typhoid). Administration of messenger ribonucleic acid (mRNA) vaccines are permitted
    • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test within 28 days prior to enrollment is required for female patients of childbearing potential
    • Lactating females who plan to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last treatment
    • Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method (failure rate of < 1% per year when used consistently and correctly) for the duration of their study drug therapy. Following therapy, patients will be advised to use contraception as per institutional practice or as listed below for investigational agents, whichever is longer
    • Men and women of childbearing potential must continue contraception for a period of 6 months after last dose of brentuximab vedotin
    • Women of child-bearing potential (WOCBP) must continue contraception for a period of at least 5 months after the last dose of nivolumab
    • All patients and/or their parents or legal guardians must sign a written informed consent
    • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • Jersey City Medical Center
    • Rutgers Cancer Institute
  • Characterizing Lymphoma Survivors Experiences, Needs, and Preferences During the Transition to Cancer Survivorship: The Survivor Health Check Program Development Trial.

    To assess information and support needs, preventive health behaviors symptoms, distress, preparedness for survivorship, and survivorship care experiences. To characterize level of interest in, preferred timing, potential delivery.

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    • Protocol Number:
      132203

    • Principal Investigator:
      Sharon Manne PhD

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Hodgkin's Lymphoma,Non-Hodgkin's Lymphoma

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sharon Manne PhD
    • Rutgers Cancer Institute
  • Exploring Patient and Caregiver Perspectives and Experiences with Financial Toxicity.

    Objectives: Aim 1: To explore patient perspectives on the implementation of FT screening, educational and navigation programming. We will interview a purposive sample of patients to include minority and those at highest risk of FT (12-14 African Americans (AA), 12-14 with low-income/education, 12-14 employed at time of diagnosis, total approximately 40 patients) in NJ. We will aim to understand their experiences related to FT, how this impacts their disease management, and what clinical support has been provided. Aim 2: To understand caregiver experiences of financial toxicity viewing FT as a family problem. We will interview a purposive group of heme-onc patient caregivers (12-14 AA, 12-14 low-income/education, total approximately 20-30 caregivers) in NJ. Caregiver interviews will elicit the changes that occurred within the family system to accommodate the changes in the families financial reality and explore potential clinical interventions that could mitigate these impacts. Aim 3: To identify organizational and community level barriers to implementation of financial navigation in cancer centers. We will purposively sample key stakeholders (n=8-10 physicians, nurses, social workers, pharmacists and administrators) in CINJ and RWJBH clinical operations to engage them in a discussion to reflect on our findings from Aim 1 & 2 and to identify key barriers/facilitators to inform implementation strategy recommendations to be tested in the next phase of our research. This iterative process involving stakeholders will help us develop a targeted FT navigation program.

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    • Protocol Number:
      132105

    • Principal Investigator:
      Biren Saraiya M.D

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Leukemia, not otherwise specified,Myeloid and Monocytic Leukemia,Hodgkin's Lymphoma,Leukemia, other

      • Contacts:

      • Rutgers University Prinicipal Investigator: Biren Saraiya M.D
    • Rutgers Cancer Institute
  • Fitness-Adapted, Pembrolizumab-Based Therapy for Untreated Classical Hodgkin Lymphoma Patients 60 Years of Age and Above. - NCT05404945

    To assess the safety and efficacy of a fitness-adapted pembrolizumab-based regimen in untreated fit older patients with cHL.

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    • Protocol Number:
      012203

    • Principal Investigator:
      Andrew Evens M.D

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Brentuximab vedotin DACARBAZINE VINBLASTINE Pembrolizumab (MK-3475) DOXORUBICIN

      • Contacts:

      • Rutgers University Prinicipal Investigator: Andrew Evens M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Participants of any sex who are ≥60 years of age on day 1, cycle 1.
    • The participant must be willing and able to provide written informed consent for the trial and participate in all planned study procedures.
    • Histologically confirmed diagnosis of classical Hodgkin lymphoma
    • PET-avid, measurable disease (≥1.5cm bi-dimensional measurement)
    • Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to
    • PS 2 may be allowed at the discretion of the treating investigator if impairment is considered to be primarily lymphoma-related. Evaluation of ECOG is to be performed within 10 days prior to the date of registration.
    • Participants who have received involved field radiation will be allowed. However, they will be excluded if any of the following are true: 1. Radiation was dosed ≤6 months from registration. 2. Radiation was delivered to > 1 lymph node group as defined by the NCCN criteria. 3. The radiation dose was ≥30 Gy. 4. The participant has radiation-related toxicities ≥ Grade 2 at the time of registration. 5. The participant requires corticosteroids for radiation-related toxicities at the time of registration (regardless of dose). 6. The participant has ever experienced radiation pneumonitis.
    • Have adequate organ function as defined per protocol. Specimens must be collected within 10 days prior to registration (confirmation of eligibility).

    Exclusion Criteria:

    • Nodular lymphocyte-predominant Hodgkin lymphoma
    • Life expectancy < 6 months for any reason excluding lymphoma
    • Has received prior therapy with an immune checkpoint inhibitor, against targets including but not limited to PD1, PDL1, PDL2, CTLA-4, OX40, or LAG 3 unless given with curative intent for reasons other than lymphoma AND the last dose was more than 3 years from registration. Any participant who received prior immune checkpoint inhibitor therapy will be excluded if they experienced any toxicity related to or possibly related to the immunotherapy that required discontinuation of drug.
    • Prior systemic therapy for cHL, with the exception of steroids
    • If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
    • Presence of Grade ≥ 2 sensory and/or motor neuropathy
    • Prior solid organ or stem cell transplant.
    • Clinical suspicion or evidence of active involvement of lymphoma into the spinal cord, cerebral spinal fluid, or brain. External compression of the spinal cord or nerve roots is not considered involvement.Has received a live vaccine or live-attenuated vaccine within 30 days prior to the firstdose of study drug. Administration of killed vaccines, subunit vaccines, and nucleic acidvaccines is allowed.
    • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.Note: Participants who have entered the follow-up phase of an investigational study mayparticipate as long as it has been 4 weeks after the last dose of the previousinvestigational agent.
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent [excluding steroids needed for lymphoma related symptoms]) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
    • Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded.
    • Has known severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
    • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
    • Interstitial lung disease or a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
    • Any known history of pancreatitis as defined by Gandhi et al. 201432,36.
    • Has an active infection requiring oral or intravenous systemic therapy.
    • Has a known history of Human Immunodeficiency Virus (HIV).
    • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Prior exposure to hepatitis B is allowed as long as there are no HBsAg detected (ie positive Hepatitis B core antibody with negative HBsAg). Prior treatment with Hepatitis C is allowed if the screening HCV RNA by PCR is negative.
    • Has a known history of active tuberculosis (TB; Mycobacterium tuberculosis).
    • Is currently taking a strong CYP3A4 modulator. Subjects taking strong CYP34A modulators that can safely stop these medications prior to treatment should complete a washout period of 4 weeks or 5 times the half-life of a particular drug, whichever is shorter.
    • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
    • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.Note: given older age at enrollment, WOCBP are not anticipated to enroll on this study.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Monmouth Medical Center
    • Jersey City Medical Center
    • Rutgers Cancer Institute
  • Machine Learning-based High-throughput and Integrative Immunological Synapse Quality Evaluation As a Composite Biomarker for Predicting CAR Therapy Efficacy in Immuno-Oncology.

    1. The primary objective is to determine if a novel fluorescent assay measuring dynamic parameters of immune synapse quality can be used to assess commercial T cell products. 2. The secondary objective is to determine if a novel fluorescent assay measuring dynamic parameters of the immune synapse can be used as a biomarker to associate with CAR-T cell efficacy and toxicity.

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    • Protocol Number:
      012108

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Multiple Myeloma,Hodgkin's Lymphoma,Non-Hodgkin's Lymphoma

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Yun Kyoung Tiger
    • Rutgers Cancer Institute
  • Needs Survey for Childhood, Adolescent, Young Adults (CAYA) Cancer Survivors, Their Siblings, and Parents/Caregivers.

    The primary objective of this project is to conduct a survey of CAYA cancer survivors who have been treated at the Rutgers Cancer Institute of New Jersey (CINJ) in New Brunswick, NJ, or the Valerie Fund Children s Center for Cancer and Blood Disorders at the Children s Hospital of New Jersey at Newark Beth Israel Medical Center (CHoNJ) in Newark, NJ, and their siblings and parents/caregivers to better understand the cancer survivorship experiences. Utilizing the results of this survey, the investigators aim to identify and understand the psychosocial functioning and needs of CAYA survivors and their families. The work will be used to guide future intervention research that focuses on improving the cancer survivorship experience at CINJ and CHoNJ for children, adolescents, and young adults as well as their siblings and parents/caregivers. Specific research questions include: 1. What is the current psychosocial functioning of CAYA survivors, siblings, and parents/caregivers? What factors are associated with better outcomes? 2. What are the healthcare management needs of CAYA survivors and their families? What factors are associated with better healthcare self-management and health behaviors? 3. To what extent has cancer impacted CAYA survivors relationships and educational/career/employment aspirations and functioning? 4. What are the unmet needs of siblings? 5. What are the unmet needs of parents?

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    • Protocol Number:
      132213

    • Principal Investigator:
      Katie Devine

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Leukemia, not otherwise specified,Brain and Nervous System,Any Site,Non-Hodgkin's Lymphoma,Leukemia, other,Hodgkin's Lymphoma,Bones and Joints

      • Contacts:

      • Rutgers University Prinicipal Investigator: Katie Devine
    • Rutgers Cancer Institute
  • Social Genomic Mechanisms of Health Disparities among Adolescent and Young Adult (AYA) Survivors of Hodgkin and Non-Hodgkin Lymphoma. - NCT06002828

    Primary Objectives: 1. To establish the association of social-environmental risk factors on both disease-free survival (DFS) and overall survival (OS) for adolescent and young adult cancer survivors. Secondary Objectives: 1. To establish the associations of individual resilience factors on DFS and OS for adolescent and young adult cancer survivors. 2. To establish the associations of social-environmental risk factors and individual resilience factors on quality of life (QOL) for adolescent and young adult cancer survivors. 3. To quantify the extent to which alterations in human gene expression could potentially mediate the effects of social-environmental risk factors and individual resilience factors on DFS, and OS for adolescent and young adult cancer survivors. Exploratory Objective: 1. To determine whether the relationship between social-environmental risk factors or individual resilience factors and distal outcomes may be moderated by race/ethnicity, sex and gender identity, and geography for adolescent and young adult cancer survivors.

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    • Protocol Number:
      012404

    • Principal Investigator:
      Andrew Evens M.D

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Hodgkin's Lymphoma,Non-Hodgkin's Lymphoma

      • Contacts:

      • Rutgers University Prinicipal Investigator: Andrew Evens M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patient must be >= 18 years of age at the time of registration
    • Patient must have been between the ages of 15-39 at the time of their first primary cancer diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma (NHL)
    • Patient must have completed therapy (with a complete response, per clinician determination) at the time of registration
    • Patients last date of prior systemic therapy for first primary diagnosis for Hodgkin lymphoma or non-Hodgkin lymphoma must have been within one year prior to registration
    • NOTE: Systemic therapy refers to all anti-cancer therapy, including but not limited to chemotherapy, intravenous (IV) or oral targeted medications, or radiation, and administered via a clinical trial or standard approach
    • Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3
    • Patient must be English speaking in order to be able to complete the required QOL forms on this study
    • NOTE: Sites cannot translate the associated QOL forms
    • Patient must not be receiving active therapy for Hodgkin lymphoma or non-Hodgkin lymphoma
    • Patient must have internet access through computer, tablet, or smartphone
    • Patient must have email address
    • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Monmouth Medical Center
    • Rutgers Cancer Institute
  • Study Protocol Cancer in Pregnancy (CIP-study) - NCT00330447

    To record the incidence, diagnosis and treatment of cancer during pregnancy and maternal (obstetrical and oncological) and fetal outcome after maternal cancer during pregnancy with long term follow-up of both mother and child.

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    • Protocol Number:
      012201

    • Principal Investigator:
      Andrew Evens M.D

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Hodgkin's Lymphoma,Non-Hodgkin's Lymphoma

      • Contacts:

      • Rutgers University Prinicipal Investigator: Andrew Evens M.D

    Read Inclusion & Exclusion Criteria

    Patients do not need to participate in both; however, preferentially both study partsshould be performed.**************Part I: Pregnancy, delivery and maternal health**************Patients must meet the following inclusion criteria:
    • Histologically proven cancer in association with a pregnancy (during pregnancy or cancer dagnosis within 5 years after pregnancy)
    • > 18 years of age, premenopausal
    • Patients who have given their signed and written informed consent to participate in the trial after fully understanding the implication of the protocol
    • Women receiving any cytotoxic drug or radiation therapy during pregnancy are allowed for the assessment of the maternal and fetal outcome (Part II).

    Exclusion Criteria:

    • Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent**************Part II: Follow-up of children**************

      Inclusion Criteria:

      • Children that were prenatally exposed to cancer of cancer treament. Informed Consent is asked from parents. From the age of 12 years, informed assent is additionally asked from the child. After the age of 18 years, informed consent is solely asked of the offspring.

      Exclusion Criteria:

      • Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Newark Beth Israel Medical Center
    • Rutgers Cancer Institute