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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Deepa Jagadeesh
Study ID
NCT04517435
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ME-401 — DRUG
    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
  • Rituximab — DRUG
    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.
  • Cyclophosphamide — DRUG
    750 mg/m2 IV Cyclophosphamide day 1 of 21-day cycle
  • Doxorubicin — DRUG
    50 mg/m2 IV Doxorubicin day 1 of 21-day cycle
  • Vincristine — DRUG
    1.4 mg/m2 (max 2 mg) IV Vincristine
  • Prednisone — DRUG
    100mg PO Prednisone Days 1-5 of 21-day cycle

Study Details

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.

Key Dates

Start date
Apr 28, 2021
Status verified
Jan 2025
Primary completion
May 17, 2023
Completion
May 17, 2023

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ME-401 + R-CHOP
    Participants will receive ME-401 dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose R-CHOP. ME-401 (60 mg) will be given on days 1-4 (dose level 1) OR days 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.

Primary Outcome Measure

Phase I: Number of Clinically Significant Non-hematologic Grade 3 or 4 Treatment-related AEs or Hematologic Grade 3 or 4 Treatment Related AEs [ Time Frame: Up to 24 months after treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer CenterClevelandOhio44195-

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By research site
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center· Cleveland, OH

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