Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT04510636|
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : January 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Classical Hodgkin Lymphoma Relapsed Cancer Refractory Cancer||Drug: Pembrolizumab Drug: Bendamustine Hydrochloride||Phase 2|
Pembrolizumab and bendamustine will be explored as a safe and effective treatment for these patients.
Although current treatment options are available for patients in the relapsed state, once these therapies fail or are not tolerated, treatment options are quite limited.
Pembrolizumab and bendamustine have both shown activity when used as a single agent as treatment for Hodgkin Lymphoma. Their side effect profiles also do not overlap, which makes them ideal to combine, with an intent to increase the amount and duration of complete responses while limiting the toxicities experienced by patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study Evaluating the Safety and Efficacy of Pembrolizumab (KEytruda) in Combination With Bendamustine (TREanda) in Relapsed/Refractory Hodgkin Lymphoma|
|Actual Study Start Date :||December 20, 2021|
|Estimated Primary Completion Date :||June 1, 2026|
|Estimated Study Completion Date :||June 1, 2026|
Experimental: Pembrolizumab and Bendamustine
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.
Pembrolizumab is a intravenously administered humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Other Name: KEYTRUDA
Drug: Bendamustine Hydrochloride
Bendamustine is a unique alkylating agent with substantial activity in hematologic malignancies.
Other Name: TREANDA
- Overall response rate [ Time Frame: 5 years ]Complete response + partial response
- Complete response rate as determined by Lugano criteria [ Time Frame: 5 years ]Assessed by positron emission tomography (PET)/computed tomography (CT) scans
- Incidence of adverse events [ Time Frame: 5 years ]
- Overall survival rate [ Time Frame: 5 years ]
- Progression-free survival rate [ Time Frame: 5 years ]
- Average duration of response [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510636
|Contact: John Kuruvilla, M.D.||email@example.com|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: John Kuruvilla, M.D. 416-946-2821|
|Principal Investigator: John Kuruvilla, M.D.|
|Principal Investigator:||John Kuruvilla, M.D.||Princess Margaret Cancer Centre|