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

NCT04934930 | Unknown Phase 2

• 1 other identifier: MMC-19-0209
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival among patients treated with 4 cycles of BO & 2 additional cycles of obinutuzumab.

  Progression-free survival is defined as the time from randomization to the earliest event of progression, relapse, or death from any cause. progression-free survival, is assessed by the investigator.

  Progression free survival will be assessed 24 months after the end of induction.

Secondary Outcomes (4)

• Progression of disease within 24 months (POD24)

  POD24 will be assessed at 24 months after treatment initiation

• Overall survival among patients treated with 4 cycles of BO & 2 additional cycles of obinutuzumab.

  Overall survival will be assessed 24 months after the end of induction.

• The rate of MRD negativity persistence at 12 months among patients treated with 4 cycles of BO & 2 additional cycles of obinutuzumab.

  Persistence of MRD negativity will be assessed 12 months after study initiation.

• The proportion of adverse events among patients treated with 4 cycles of BO & 2 additional cycles of obinutuzumab.

  The proportion of various adverse events will be assessed until 24 months from the end of induction.

Study Arms (1)

Reduced number of bendamustine cycles in patients with mid-induction MRD negativity

EXPERIMENTAL

Patients with follicular lymphoma treated with obinutuzumab bendamustine \& achieving MRD negativity as well as complete metabolic response on PET-CT at mid-induction would continue obinutuzumab treatment while omitting bendamustin after 4 cycles.

Drug: Bendamustin; Drug: Obinutuzumab

Interventions

Bendamustin DRUG

Chemotherapy

Also known as: Ribomustin

Reduced number of bendamustine cycles in patients with mid-induction MRD negativity

Obinutuzumab DRUG

Immunotherapy

Also known as: Gazyva

Reduced number of bendamustine cycles in patients with mid-induction MRD negativity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status grade 0-2.
• The presence of a molecular marker in bone marrow or peripheral blood for MRD assessment.

You may not qualify if:

• FL grade IIIb.
• HIV infection.
• HBsAg positivity.
• Active malignancy other than FL
• Pregnancy or lactation.

Sponsors & Collaborators

• Meir Medical Center: lead
• Rabin Medical Center: collaborator
• Tel-Aviv Sourasky Medical Center: collaborator
• Assuta Ashdod Hospital: collaborator
• Ziv Medical Center: collaborator

Study Sites (1)

Meir medical center

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Bendamustine Hydrochloride; obinutuzumab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Uri Abadi, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uri Abadi, MD

CONTACT

972-9-7472786; uri.abadi@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective multicenter, single arm, phase II study

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: June 22, 2021
• Study Start: January 29, 2020
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)