MRD Guided De-intensification of Bendamustine/Rituximab for Indolent Non-Hodgkin Lymphoma

ConditionsLymphoma Indolent Non-hodgkin Lymphoma

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-99

SponsorFox Chase Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Follicular Lymphoma (Grade 1-3a)

Marginal Zone Lymphoma

Lymphoplasmacytic Lymphoma

Age > 18 years

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Bendamustine
Drug
Bendamustine will be administered as 10 minute IV infusion at 90 mg/m2 (drug dose calculation is based on treatment day weight) on days 1 and 2 for 4-6 cycles (number of cycles determined per treatment design). Subjects will be dosed every 28 days. Ondansetron 16 mg IV is given as premedication per institutional guidelines. Dose modifications will be determined based on renal and hepatic function. Subjects should be carefully monitored for infusion reactions during Bendamustine administration. If an acute infusion reaction is noted, subjects should be managed according to institutional guidelines. Doses of Bendamustine may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment based on physician discretion.
Rituximab
Drug
Rituximab will be administered as an IV infusion at 375 mg/m2 (longer for the first dose) (drug dose calculation is based of treatment day weight) on day 1 for 4-6 cycles (number of cycles determined per treatment design). Infusion rate will be determined as per institutional standards. Subjects will be dosed every 28 days. Diphenhydramine 50 mg IV and acetaminophen 650 mg are required to be given to the subjects within 30 minutes prior to Rituximab dose. There are no dose modifications recommended with Rituximab. If an acute infusion reaction is noted, subjects should be managed according to institutional guidelines. Doses of Rituximab may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment.

Treatment groups

24 Participants

are divided into 1 treatment group

Group A: Single ArmExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

PFS Evaluation

To evaluate the 2-year progression free survival (PFS) for patients treated with Bendamustine and Rituximab (BR) with measurable residual disease directed (MRD) duration of therapy.

Time frame

2 years

Statistical PFS

The proportion (p) of patients who are progression-free and are alive at 2 years from the initiation of treatment using Lugano Criteria.

Time frame

2 years

Secondary outcomes

Secondary Outcome Measure

Assess additional clinical outcomes including overall survival (OS),

Time frame

2 years

Measurable Residual Disease Evaluation

To determine the rate of MRD (minimal residual disease) negativity at end of treatment and at 2 years post-treatment

Time frame

2 years

Adverse Event assessment

Assess adverse effects of treatment

Time frame

2 years

Overall Survival Assessment

OS, defined as time from initiation of study treatment until death, or the end of follow-up, whichever occurs first. Patients who are still alive at the end of follow-up will be considered censored.

Time frame

2 years

Other outcomes

Exploratory Outcome Measures

Assess and compare measurable residual disease (MRD) sensitivity of both circulating tumor DNA (ctDNA) and circulating tumor cells (CTC), both being obtained at baseline, after each cycle, and during follow up

Time frame

2 years

Measurable Residual Disease (MRD)

Assess MRD level, both ctDNA and circulating tumor cell (CTC) testing, after each cycle of Bendamustine and Rituximab (BR) and correlate with Progression Free Survival (PFS)

Time frame

2 years

Progression Free Survival (PFS) for Measurable Residual Disease (MRD)

To evaluate PFS for patients with low level detectable MRD (10\^-4 to 10\^-6) after 3 cycles of Bendamustine and Rituximab

Time frame

2 years

Measurable Residual Disease (MRD) to guide indolent lymphoma treatment evaluation

Evaluate feasibility of using MRD to guide treatment for indolent lymphoma

Time frame

2 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fox Chase Cancer Center

Lead sponsor

Adaptive Biotechnologies

Collaborator

Source ClinicalTrials.gov

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