POLA+BR for Relapsed or Refractory DLBCL
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|ClinicalTrials.gov Identifier: NCT04535102|
Recruitment Status : Not yet recruiting
First Posted : September 1, 2020
Last Update Posted : October 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B Cell Lymphoma||Drug: Polatuzumab Vedotin||Phase 2|
The first day of treatment will constitute Cycle 1 Day 1. Patients will be treated with a minimum of 3 cycles to upto a maximum six cycles to optimize response prior to ASCT per investigator discretion.
All patients will be evaluated for safety and efficacy according to the schedules of assessments.
All patients will be assessed for response to treatment by the investigator with the use of standard criteria according to the Modified Lugano Response Criteria (Cheson et al. 2014; see Appendix 3) at screening and at the following timepoints:
- At the time of screening
- At the time of primary response assessment, 3 weeks after completion of study treatment (i.e., 3 weeks after Day 1 of Cycle 3 or after last dose of study medication)) Imaging at these timepoints must include FDG-PET (18F-fluorodeoxyglucose-positron emission tomography) and a diagnostic-quality CT scan with both oral and IV contrast. A combined PET/CT scan is encouraged if feasible. CT scans with oral and IV contrast should include neck, chest, abdomen, and pelvic scans. In patients for whom contrast is contraindicated, (e.g., patients with contrast allergy or impaired renal clearance or patient denial), PET-CT scans without contrast are permitted so long as they permit consistent and precise measurement of target lesions during the study treatment period.
Patients will also be evaluated every 3 months for 2 years, or until disease progression, death, withdrawal of consent, or initiation of another anti-cancer therapy. Tumor assessments should also be performed to confirm clinical suspicion of relapse or disease progression for documentation. The study will end when all patients enrolled have been followed until death, have withdrawn consent, have been lost to follow-up, until 2-year follow up, or the Sponsor decides to end the trial, whichever occurs first.
Once the last patient enrolls and undergoes EOT PET-CT assessment, primary endpoint data and interim survival analysis will be evaluated and published/presented at meetings. Subsequent survival analysis will be published post 2-yr follow-up
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||POLATUZUMAB PLUS BENDAMUSTINE PLUS RITUXIMAB (POLA+BR) AS SALVAGE THERAPY PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANT FOR PATIENTS WITH RELAPSED OR PRIMARY REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA|
|Estimated Study Start Date :||December 2020|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||May 2024|
Experimental: Polatuzumab + BR (minimum 3 cycles)
Patients will be treated with a minimum of 3 cycles up to a maximum six cycles to optimize response prior to ASCT (stem cell transplant) per investigator discretion
Drug: Polatuzumab Vedotin
Polatuzumab vedotin is an ADC designed for the targeted delivery of MMAE(mono-methyl auristatin E), a potent microtubule inhibitor to lymphoma cells expressing CD79b. MMAE has a mechanism of action that is similar to that of vincristine.
- Complete response at primary response [ Time Frame: 3 weeks after last dose of study medication ]The assessment is based on PET/CT, as determined by the investigator
- objective response at primary response [ Time Frame: 3 weeks after last dose of study medication ]assessment based on PET/CT as determined by the investigator
- duration of response (DOR) of combination therapy [ Time Frame: 2 years of follow up ]DOR, defined as the time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause based on PET/CT or CT only as determined by the investigator assessment.Response assessment will be determined according to Modified Lugano Response Criteria for Malignant Lymphoma (Lugano Classification)
- number of patients who underwent an ASCT [ Time Frame: 2 years of follow up ]Determined during follow up
- Cell of Origin analysis [ Time Frame: 2 years of follow up ]Cell of origin analysis will be based on immunohistochemistry analysis
- Differences in response rates based on timing of relapse [ Time Frame: 2 years of follow up ]<12 months of front-line R-chemotherapy versus >12 months after front-line R-chemotherapy and bulky disease prior to ASCT (bulk defined as mass > 7.5 cms)
- c-Myc status [ Time Frame: 2 years of follow up ]by FISH
- 2-yr progression free survival (PFS) [ Time Frame: 2 years of follow up ]PFS, defined as the time from date of first treatment to the first occurrence of progression or relapse, or death from any cause, based on PET/CT or CT only as determined by the investigator assessment
- overall survival (OS) [ Time Frame: 2 years of follow up ]defined as the time from the date of randomization or first treatment to the date of death from any cause
- stem cell collection failure rate [ Time Frame: 2 years of follow up ]Stem cells will be collected post primary response assessment. If patients achieve a PR after 3 cycles of Pola+BR and investigator decides to give additional cycles of Pola+BR (up to a max of 6 cycles) then stem cell collection may occur between cycles to minimize the chances of collection failure.
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): NCT04535102
|Contact: Derek Schatzfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Hospital|
|Aurora, Colorado, United States, 80045|
|Contact: Derek Schatz 720-848-0628 email@example.com|
|Principal Investigator: Manali Kamdar|