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

NCT04934930 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-06-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Bendamustin

Chemotherapy

DRUG

Obinutuzumab

Immunotherapy

Sponsors & Collaborators

  • Rabin Medical Center

    collaborator OTHER

  • Tel-Aviv Sourasky Medical Center

    collaborator OTHER_GOV

  • Assuta Ashdod Hospital

    collaborator OTHER

  • Ziv Medical Center

    collaborator OTHER

  • Meir Medical Center

    lead OTHER

Principal Investigators

  • Uri Abadi, MD · Meir Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-29
Primary Completion
2025-08-01
Completion
2025-08-01

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04934930 on ClinicalTrials.gov