Pembrolizumab + Bendamustine for Hodgkin's Lymphoma
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University Health Network, Toronto
Must not be taking: Investigational agents, Monoclonal antibodies
Disqualifiers: Active malignancy, Autoimmune disease, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This is a phase 2 open-label study to test the safety and effectiveness of combining pembrolizumab and bendamustine in patients with relapsed (cancer that has come back or started getting worse) or refractory (cancer that is not responding or has stopped responding to treatment) Hodgkin lymphoma.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot be on any other chemotherapy, radiotherapy, or investigational agents within 4 weeks of starting the trial treatment.
What data supports the effectiveness of the drug combination Pembrolizumab and Bendamustine for treating Hodgkin's Lymphoma?
Research shows that Bendamustine, when used with other drugs, has high response rates in treating relapsed or refractory Hodgkin's Lymphoma, with 85% of patients responding to treatment. This suggests that Bendamustine can be effective in similar settings, potentially supporting its use with Pembrolizumab.
12345Is the combination of Pembrolizumab and Bendamustine generally safe for humans?
Bendamustine has been used safely in treating certain types of blood cancers, but it can cause skin reactions, including severe rashes, especially when combined with other drugs. Pembrolizumab is generally considered safe, but like all medications, it can have side effects, so it's important to discuss potential risks with your doctor.
678910Eligibility Criteria
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.Inclusion Criteria
I have been treated with pembrolizumab or similar, but not with bendamustine.
I had a stem cell transplant over 100 days ago, with mild or no side effects, and I'm not on immunosuppressants.
I am a woman who can have children and have a recent negative pregnancy test.
+23 more
Exclusion Criteria
I am eligible for a stem cell transplant but may choose not to have it.
I have an autoimmune disease that needed treatment in the last 2 years.
I have had a stem cell transplant from a donor.
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive pembrolizumab and bendamustine in 3-week cycles
24 months
Up to 35 cycles, with pembrolizumab every cycle and bendamustine on Days 1 and 2 of the first 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
5 years
Participant Groups
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.
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.
Bendamustine Hydrochloride is already approved in United States, European Union, Japan for the following indications:
🇺🇸 Approved in United States as Treanda for:
- Chronic lymphocytic leukemia (CLL)
- Non-Hodgkin lymphoma (NHL)
🇪🇺 Approved in European Union as Levact for:
- Chronic lymphocytic leukemia (CLL)
- Non-Hodgkin lymphoma (NHL)
- Multiple myeloma
🇯🇵 Approved in Japan as Ribomustin for:
- Chronic lymphocytic leukemia (CLL)
- Non-Hodgkin lymphoma (NHL)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Princess Margaret Cancer CentreToronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
References
Phase II multicenter study of bendamustine plus rituximab in patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma. [2022]Bendamustine HCl is a bifunctional mechlorethamine derivative with clinical activity in the treatment of non-Hodgkin's lymphoma. This study evaluated bendamustine plus rituximab in 67 adults with relapsed, indolent B-cell or mantle cell lymphoma without documented resistance to prior rituximab.
Lymphocyte-monocyte ratio (LMR) can predict bendamustine therapeutic efficacy in low-grade B-cell lymphoma. [2021]Bendamustine has been reported to be effective against low-grade B-cell lymphoma. We examined the effect of bendamustine on the lymphocyte-monocyte ratio (LMR) in low-grade B-cell lymphoma patients.
Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. [2022]To determine the efficacy and safety of bendamustine as a single agent in refractory or relapsed T-cell lymphomas.
Bendamustine with rituximab, etoposide and carboplatin (T(R)EC) in relapsed or refractory aggressive lymphoma: a prospective multicentre phase 1/2 clinical trial. [2022]We sought to develop a safe and effective outpatient salvage regimen by replacing ifosfamide within the (R)ICE (rituximab, ifosfomide, carboplatin, etoposide) regimen with bendamustine (T(R)EC) via a multicentre phase I/II study for patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) and classic Hodgkin lymphoma (HL). Therapy consisted of 60-120 mg/m2 per day bendamustine on days 1 and 2 in combination with carboplatin, etoposide and rituximab (only for CD20+ lymphoma) used in the (R)ICE regimen for up to 2 cycles. The objectives were to define a maximally tolerated dose (MTD) of bendamustine, determine safety and toxicity, assess efficacy, and evaluate impact on stem cell collection. Forty-eight patients were treated of which 71% had refractory disease. No dose-limiting toxicities were observed. The recommended phase II dose of bendamustine was 120 mg/m2 per day on days 1 and 2. Response rates were 85% (70% complete response, CR) in HL, and 65% (40% CR) in DLBCL. Stem cell collection was successful in 30 of 32 patients. The most common non-haematological toxicities ≥grade 3 were febrile neutropenia (8%) and dehydration (8%). The T(R)EC regimen safely yields high response rates, successfully mobilizes peripheral blood stem cells and compares favourably to RICE, offering an effective outpatient treatment option for patients with relapsed or refractory DLBCL and HL.
High anti-lymphoma activity of bendamustine/mitoxantrone/rituximab in rituximab pretreated relapsed or refractory indolent lymphomas and mantle cell lymphomas. A multicenter phase II study of the German Low Grade Lymphoma Study Group (GLSG). [2019]On the basis of a preceding phase I study, the current trial explored bendamustine in combination with mitoxantrone and rituximab (BMR) in patients with stage III/IV relapsed or refractory indolent lymphomas and mantle cell lymphoma (MCL) with or without prior rituximab containing chemo-immunotherapy (R-chemo) treatment. Therapy consisted of bendamustine 90 mg/m(2) days 1 + 2, mitoxantrone 10 mg/m(2) day 1, rituximab 375 mg/m(2) day 8. Treatment was repeated on day 29 for a total of four cycles. Between 3 April and 04 July, 57 patients were recruited from 24 participating institutions, 39% of whom had received prior R-chemo therapy. Median age was 66 years (40 - 83). Lymphoma subtypes were 29 follicular (FL), 18 MCL, and 10 other indolent lymphomas. The overall response rate (ORR) was 89% with 35% CR and 54% PR. ORR in R-chemo pretreated patients was 76% (38% CR, 38% PR). After a median observation time of 27 months (1 - 43), the estimated median progression free survival is 19 months. The 2 year overall survival is 60% for patients with FL and MCL. Treatment related toxicities of grade 3/4 comprised a reversible myelosuppression (10% anemia, 78% leukocytopenia, 46% granulocytopenia, 16% thrombocytopenia). However, unexpected hospitalisations were necessary after 4% of BMR-application only. BMR is a very effective new outpatient immuno-chemotherapy with low toxicity for patients with relapsed/refractory FL, MCL and other indolent lymphomas.
Long-term safety experience with bendamustine for injection in a real-world setting. [2017]Bendamustine hydrochloride (bendamustine) was approved for first-line treatment of patients with chronic lymphocytic leukemia (CLL) and relapsed indolent B-cell non-Hodgkin's lymphoma (NHL). Pharmacovigilance data have been collected since bendamustine's approval to enhance understanding of its long-term safety profile. Here we provide an overview of the pharmacovigilance data for bendamustine that have led to label updates related to safety and administration since its approval.
Effectiveness of bendamustine in relapsed or refractory lymphoma cases: a Turkish Oncology Group study. [2022]We aimed to investigate the efficacy and side effects of bendamustine in relapsed/refractory lymphoma patients in Turkey.
Severe cutaneous interface drug eruption associated with bendamustine. [2015]Bendamustine is an anti-neoplastic agent approved by the FDA in 2008 for use as monotherapy or in combination with other agents to treat chronic lymphocytic leukemia (CLL) and progressed indolent B-cell non-Hodgkin lymphoma (NHL). In clinical trials and post-marketing safety reports administration of bendamustine with drugs that have known adverse reactions (i.e., allopurinol, rituximab) has been associated with rash, toxic skin reactions, and bullous exanthems. Here, we describe a patient with NHL who developed a severe cutaneous reaction associated with the administration of bendamustine. The severity of this drug eruption identifies an important adverse reaction with this drug and a potential cause for patient morbidity.
[Efficacy Analysis of Bendamustine-Based Combination Regimen in Treatment of Patients with Relapsed/Refractory Non-Hodgkin Lymphoma]. [2022]To investigate the efficacy and safety of bendamustine combined with gemcitabine, vinorelbine，glucocorticoids (BeGEV)±X regimen in treatment of patients with relapsed/refractory non-Hodgkin lymphoma.
Bendamustine in chronic lymphocytic leukemia and non-Hodgkin's lymphoma. [2015]Bendamustine (Treanda(®); Pharmachemie BV, The Netherlands for Cephalon, Inc., PA, USA) is a unique cytotoxic agent with both alkylating and antimetabolite properties. A growing body of evidence demonstrates its efficacy in a number of hematologic malignancies, and as such, it has been US FDA approved for the treatment of chronic lymphocytic leukemia and non-Hodgkin's lymphoma that has not responded to, or progressed within 6 months of, a rituximab-based regimen. Bendamustine has efficacy both as a single agent as well as in combination with other chemotherapeutics and immunotherapeutics. Here, we will discuss in the detail the molecular properties, clinical efficacy and safety profile of bendamustine.