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ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma

NCT04517435 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-02-07

Study results available
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Summary

This study is being done to evaluate if ME-401 can improve the treatment of patients with diffuse large b-celllymphoma (DLBCL). Many patients with DLBCL that are treated with the standard of care (R-CHOP) are cured. However, a little less than half of patients will have their cancer come back despite being treated. Once DLBCL comes back, it is much harder to treat and treatment is much more aggressive. This study will combine ME-401 with R-CHOP. There are 2 parts to this study: part1 referred to as phase I and part 2 referred to as phase 2. The goal of the phase I study is to find the safest dose to give patients in combination with R-CHOP. The goal of the phase 2 study is to use the safest dose (found in phase 1) in combination with R-CHOP to see if it decreases the rate of cancer coming back after it is treated.

Conditions

  • Diffuse Large B-Cell Lymphoma

Interventions

DRUG

ME-401

ME-401 (60 mg) will be given by mouth every 21 days for 6 cycles on days 1-4 (dose level 1) OR days 1-7 (dose level 2) of a 21 day cycle. Dose escalation will be performed in a standard 3+3 design

DRUG

Rituximab

375 mg/m2 IV/subcutaneous rituximab day 1 of 21-day cycle. First dose of rituximab will be given IV and subsequent doses can be either IV or SQ based on institutional guidelines.

DRUG

Cyclophosphamide

750 mg/m2 IV Cyclophosphamide day 1 of 21-day cycle

DRUG

Doxorubicin

50 mg/m2 IV Doxorubicin day 1 of 21-day cycle

DRUG

Vincristine

1.4 mg/m2 (max 2 mg) IV Vincristine

DRUG

Prednisone

100mg PO Prednisone Days 1-5 of 21-day cycle

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    collaborator OTHER

  • Deepa Jagadeesh

    lead OTHER

Principal Investigators

  • Deepa Jagadeesh, MD, MPH · Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer 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
2021-04-28
Primary Completion
2023-05-17
Completion
2023-05-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT04517435 on ClinicalTrials.gov