Clinical trial for Hodgkin Lymphoma
Official title Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT03618550
What this study is testing
What is pembrolizumab?
pembrolizumab is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for hodgkin lymphoma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether pembrolizumab combined with GVD works and is safe for relapsed Hodgkin lymphoma.
- Who it's for
- You may be able to join if you have Hodgkin lymphoma that has returned or did not respond to treatment.
- What's involved
- You would receive pembrolizumab (a medicine that helps the immune system) and GVD (a chemotherapy mix) through IV. You will also have regular doctor visits and tests.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologic diagnosis of classical Hodgkin's lymphoma. Primary refractory or relapsed disease proven by biopsy at enrolling institution.
- Be willing and able to provide written informed consent/assent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- PET scan before initiating pembro-GVD have measurable disease based on Lugano 2014 criteria
- Have a performance status of 0 or 1 on the ECOG Performance Scale
You likely can't join if
- Known pregnancy or breast-feeding.
- Breast-feeding should be discontinued prior to treatment initiation.
- Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and/or principal investigator, makes participation...
- Has received prior radiotherapy within 2 weeks of start of study treatment.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e.
See the full eligibility criteria
- Histologic diagnosis of classical Hodgkin's lymphoma. Primary refractory or relapsed disease proven by biopsy at enrolling institution.
- Be willing and able to provide written informed consent/assent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- PET scan before initiating pembro-GVD have measurable disease based on Lugano 2014 criteria
- Have a performance status of 0 or 1 on the ECOG Performance Scale
- Demonstrate adequate organ function as defined in table below
- Demonstrate adequate organ function as defined in table below. Hematological\
- Absolute neutrophil count (ANC) ≥1000 /mcL
- Platelets ≥50,000 / mcL
- Hemoglobin ≥8 g/dL Renal
- Serum creatinine OR ≤1.5 X upper limit of normal (ULN) OR
- Measured or calculated creatinine clearance (eGFR can also be used in place of creatinine) ≥60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN Hepatic\
- Serum total bilirubin ≤ 1.5 X ULN OR ≤ 3 X ULN for people with liver metastases
- AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for people with liver metastases Pulmonary
- Hemoglobin-adjusted diffusing capacity for carbon monoxide ≥50% (If unadjusted DLCO is \>/= 50% then there is no need to calculate adjusted) Cardiac
- Ejection fraction ≥45% Coagulation
- International normalized ratio (INR) OR prothrombin time (PT), Activated partial thromboplastin time (aPTT): ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic...
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 2 weeks prior to receiving the first dose of study medication.
- Female people of childbearing potential must be willing to use an adequate method of contraception (see details in section 11.4.3).
- Male people of childbearing potential must agree to use an adequate method of contraception.(see details in section 11.4.3).
- Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening
- Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the LLOQ (below the limit of detection) using the locally available assay at the time...
- It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.
- Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study
- Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline.
- Known pregnancy or breast-feeding.
- Breast-feeding should be discontinued prior to treatment initiation.
- Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and/or principal investigator, makes participation in this study inappropriate.
- Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- 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).
- Has known active HIV, Hepatitis B (e.g., Hepatitis B PCR positive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- Has a history of pneumonitis related to PD-1 blockade that required steroids.
- Has an active infection requiring systemic therapy.
- Has not adequately recovered from major surgery or has ongoing surgical complications
- Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Stanford, California, United States
- Miami, Florida, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Stanford, California, United States; Miami, Florida, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.