Overview

Adjustment of Chemotherapy Duration in Follicular Lymphoma According to Minimal Residual Disease Status

Status:
Recruiting

Trial end date:
2025-08-01

Target enrollment:
0

Participant gender:
All

Summary

Follicular lymphoma (FL) is a chronic indolent malignancy, where treatment with 6 cycles of bendamustine obinutuzumab (BO) is highly effective but at a cost of increased adverse events. Tumor specific DNA can be traced in blood and bone marrow of follicular lymphoma patients even after therapy, and when detected after lymphoma treatment it is referred to as minimal residual disease (MRD). MRD elimination after effective lymphoma treatment is a marker for deep response and correlates with prolonged remission. In this study we aim to omit chemotherapy after 4 cycles of treatment in patients achieving MRD elimination after 3 months of therapy, as well as complete metabolic response on positron emission computed tomography (PET-CT), hoping to preserve treatment effectiveness while reducing adverse events.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Meir Medical Center

Collaborators:

Assuta Ashdod Hospital
Rabin Medical Center
Tel-Aviv Sourasky Medical Center
Ziv Medical Center

Treatments:

Bendamustine Hydrochloride
Obinutuzumab

Criteria

Inclusion Criteria:

1. Age 18 and above.

2. FL grade I-IIIa, according to world health organization (WHO) classification, in
patients who were not previously treated with chemotherapy, have a high tumor bulk &
an indication for treatment, as defined by the Groupe d'Etude des Lymphomes
Folliculaires (GELF) criteria.

3. Eastern Cooperative Oncology Group (ECOG) performance status grade 0-2.

4. The presence of a molecular marker in bone marrow or peripheral blood for MRD
assessment.

Exclusion Criteria:

1. FL grade IIIb.

2. HIV infection.

3. HBsAg positivity.

4. Active malignancy other than FL

5. Pregnancy or lactation.