Status:
NOT_YET_RECRUITING
MRD Guided De-intensification of Bendamustine/Rituximab for Indolent Non-Hodgkin Lymphoma
Lead Sponsor:
Fox Chase Cancer Center
Collaborating Sponsors:
Adaptive Biotechnologies
Conditions:
Lymphoma
Indolent Non-hodgkin Lymphoma
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
This is a phase II pilot, single arm, open label study designed to assess the efficacy, safety, and feasibility of MRD adapted duration of BR for untreated or R/R iNHL.
Detailed Description
This is a phase II pilot, single arm, open label study designed to assess the efficacy, safety, and feasibility of MRD adapted duration of BR for untreated or R/R iNHL. All patients with untreated or...
Eligibility Criteria
Inclusion
- Patients must have pathologically confirmed:
- indolent Non-Hodgkin Lymphoma, consistent with one of the below diagnoses:
- Follicular Lymphoma (Grade 1-3a)
- Marginal Zone Lymphoma
- Lymphoplasmacytic Lymphoma
- Patient may be treatment naïve or relapsed/refractory without having received prior Bendamustine or patients recently started on Bendamustine 90 mg/m2 with Rituximab 375 mg/m2 are eligible if C2D1 BR is no more than 14 days prior to enrollment and they otherwise meet eligibility criteria
- Age \> 18 years
- ECOG performance status 0-2
- Patients must have normal organ and marrow function as defined below:
- Absolute Neutrophil Count \>1000mm3 and Hemoglobin \>8 g/dL (unless due to bone marrow involvement by lymphoma)
- Total bilirubin \> 1.5x upper limit of normal (patients with Gilbert's syndrome can have total bilirubin up to 3x upper normal limit)
- Aspartate aminotransferase/ alanine aminotransferase (serum glutamic-oxaloacetic transaminase/ serum glutamic-pyruvic transaminase) \< 5 times institutional normal limits
- Creatinine clearance \> 30 Ml/min
Exclusion
- Radiation or systemic treatment for lymphoma within the past 28 days prior to cycle 1 day 1 of BR.
- Patients with pathologically confirmed transformed lymphoma, including diffuse large B cell lymphoma or other high grade lymphomas
- Patients on active treatment for second malignancy with the exception of endocrine therapy for non-metastatic breast cancer, hormone therapy for prostate cancer, or local treatment for non-melanoma skin cancer.
- Pregnant or breast-feeding. Refer to section 5.4 for further detail.
- Failure to identify a dominant clonal sequence with ClonoSEQ from pre-treatment specimen or inadequate tissue for testing
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06557330
Start Date
June 1 2025
End Date
March 30 2028
Last Update
January 6 2025
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