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Alkylating agents
Pembrolizumab + Bendamustine for Hodgkin's Lymphoma
Phase 2
Recruiting
Led By John Kuruvilla, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have failed or declined autologous stem cell transplantation (ASCT), or not be a candidate for ASCT.
Must have Eastern Cooperative Group (ECOG) performance status 0-1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing a new combination cancer treatment to see if it is safe and effective in patients with Hodgkin lymphoma that has relapsed or stopped responding to other treatments.
Who is the study for?
This trial is for adults with relapsed or refractory classical Hodgkin Lymphoma who've had standard chemotherapy and possibly a stem cell transplant. They should be in good physical condition (ECOG 0-1), have a life expectancy over 90 days, and adequate organ function. Women must test negative for pregnancy and all participants agree to use contraception during the study.Check my eligibility
What is being tested?
The study tests combining pembrolizumab, an immunotherapy drug, with bendamustine hydrochloride, a chemotherapy agent. It's open-label meaning everyone knows what treatment they're getting. The goal is to see if this combo is safe and works better for those whose lymphoma has returned or isn't responding.See study design
What are the potential side effects?
Possible side effects include allergic reactions to either drug, immune system complications due to pembrolizumab potentially attacking healthy cells, infusion-related reactions from both drugs, fatigue from bendamustine, as well as increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not eligible for, have declined, or did not respond to a stem cell transplant.
Select...
I am fully active or can carry out light work.
Select...
My Hodgkin Lymphoma has returned or didn't fully respond to the last treatment.
Select...
I have had first-line chemotherapy with an anthracycline for Hodgkin Lymphoma.
Select...
I've had first-line chemotherapy with an anthracycline for Hodgkin Lymphoma.
Select...
I cannot have or have chosen not to have a stem cell transplant using my own cells.
Select...
I am fully active or can carry out light work.
Select...
I can attend all treatment, assessment, and follow-up appointments.
Select...
My Hodgkin Lymphoma has returned or didn't fully respond to the last treatment.
Select...
I am available for all treatments, assessments, and follow-ups.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response rate as determined by Lugano criteria
Overall response rate
Secondary outcome measures
Average duration of response
Incidence of adverse events
Overall survival rate
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab and BendamustineExperimental Treatment2 Interventions
The study drugs will be given in 3 week periods called cycles.
Pembrolizumab is available in powder form or as a liquid for infusion. Pembrolizumab at a dose of 200 mg will be given over 30 minutes, once every cycle for up to 35 cycles (approximately 24 months).
Bendamustine is available in powder form for injection. Bendamustine at a dose of 90 mg/m2 will be given over 60 minutes, on Days 1 and 2 of every cycle for up to 6 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Bendamustine Hydrochloride
2011
Completed Phase 2
~230
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,475 Previous Clinical Trials
485,053 Total Patients Enrolled
John Kuruvilla, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with pembrolizumab or similar, but not with bendamustine.I am eligible for a stem cell transplant but may choose not to have it.I had a stem cell transplant over 100 days ago, with mild or no side effects, and I'm not on immunosuppressants.I have an autoimmune disease that needed treatment in the last 2 years.I am a woman who can have children and have a recent negative pregnancy test.I am not eligible for, have declined, or did not respond to a stem cell transplant.I had a stem cell transplant over 100 days ago, with minor or no side effects and I'm not on immunosuppressants.I have had a stem cell transplant from a donor.I have not received a live vaccine in the last 30 days.I haven't had chemotherapy, radiotherapy, or other cancer treatments in the last 4 weeks.I haven't had a monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.I have an active brain or spinal cord condition.I do not have any severe ongoing illnesses like serious infections, heart failure, or unstable heart conditions.I am fully active or can carry out light work.My Hodgkin Lymphoma has returned or didn't fully respond to the last treatment.My cancer progressed while on or soon after immunotherapy without other treatments in between.I have had pneumonitis treated with steroids or currently have it.I have had first-line chemotherapy with an anthracycline for Hodgkin Lymphoma.I have been cancer-free and off treatment for more than 3 years, except for non-melanoma skin cancer or treated cervical carcinoma in situ.I've had first-line chemotherapy with an anthracycline for Hodgkin Lymphoma.I am a woman who can have children and have a negative pregnancy test within the last 3 days.I have been treated with pembrolizumab or similar, but not with bendamustine.I cannot have or have chosen not to have a stem cell transplant using my own cells.I am highly allergic to pembrolizumab or bendamustine.I haven't used any experimental drugs or devices in the last 4 weeks.I have a history of HIV, active TB, or active hepatitis B/C.I am fully active or can carry out light work.My organs and bone marrow are functioning well.I have been treated with bendamustine before.I have been taking more than 10 mg/day of steroids for at least a week.I can attend all treatment, assessment, and follow-up appointments.My Hodgkin Lymphoma has returned or didn't fully respond to the last treatment.I am available for all treatments, assessments, and follow-ups.My organs and bone marrow are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab and Bendamustine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants being accepted into the research project at this time?
"The listing on clinicaltrials.gov makes it clear that this trial is actively recruiting patients. First posted on December 20th, 2021 and edited more recently on December 31st, the study needs 37 patients from a single location."
Answered by AI
How many subjects are participating in this research?
"Yes, this is an ongoing recruitment for a clinical trial that was first posted on December 20th, 2021 and last edited on December 31st, 2021. The goal is to have 37 patients enrolled from 1 site."
Answered by AI
What are the main conditions that Pembrolizumab is prescribed for?
"Pembrolizumab is the standard course of treatment for unresectable melanoma. Additionally, Pembrolizumab has been shown to be effective in treating other conditions such as microsatellite instability high, high risk of recurrence, and disease."
Answered by AI
Has Pembrolizumab received clearance from the FDA?
"Pembrolizumab, while having some evidence backing its safety via Phase 2 trials, has yet to have any efficacy data. Therefore, it was given a score of 2."
Answered by AI
Could you please provide Pembrolizumab's clinical trial history?
"Pembrolizumab is being researched in 1081 active clinical trials, 143 of which are Phase 3 studies. The majority of Pembrolizumab research is conducted in Houston, Texas; however, there are 40991 locations worldwide where patients can access these treatments."
Answered by AI
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