ME-401 + R-CHOP for Non-Hodgkin's Lymphoma

Overseen By Deepa Jagadeesh, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Deepa Jagadeesh

Must be taking: R-CHOP

Must not be taking: Investigational agents, Antiretrovirals

Disqualifiers: CNS involvement, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 42

13 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Deepa Jagadeesh

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with newly diagnosed diffuse large B-cell lymphoma (DLBCL), including those whose indolent lymphoma has transformed to DLBCL, provided they haven't been treated for it. They must have a certain level of physical fitness and organ function, measurable disease, no prior therapy with specific inhibitors, and agree to use contraception. Excluded are those with CNS involvement by lymphoma, uncontrolled illnesses or allergies related to the drugs used in the trial.

Inclusion Criteria

- Participants must have the ability to understand and the willingness to sign a written informed consent document.

-- LDH >upper limit of normal

- QT-interval corrected according to Fridericia's formula (QTcF) ≤450 milliseconds (ms); participants with QTc < 480 msec may be enrolled provided the QTc prolongation is due to a right bundle branch block and stable.

Exclusion Criteria

I do not have uncontrolled immune-related blood disorders.

I am currently experiencing lung inflammation due to medication.

My lymphoma has spread to my brain or spinal cord, or I'm at high risk for it.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Participants receive ME-401 in combination with R-CHOP to determine the recommended phase 2 dose (RP2D) and assess tolerability

6 cycles of 21 days each

Visits every 21 days for each cycle

Phase II Treatment

Participants receive the RP2D of ME-401 in combination with R-CHOP to evaluate clinical activity and response rates

6 cycles of 21 days each

Visits every 21 days for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of progression-free survival and treatment-related adverse events

24 months

Treatment Details

Interventions

• Cyclophosphamide
• Doxorubicin
• ME-401
• Prednisone
• Rituximab
• Vincristine

Trial Overview The study tests ME-401 combined with R-CHOP chemotherapy regimen against DLBCL. It's split into two parts: Phase I aims to find the safest dose of ME-401 when used with R-CHOP; Phase II will then test this safe dose's effectiveness at preventing cancer recurrence after treatment.

Participant Groups

Group I: ME-401 + R-CHOP Experimental Treatment 6 Interventions

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.

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Cytoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in European Union as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Canada as Neosar for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Japan as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma

Who Is Running the Clinical Trial?

Deepa Jagadeesh

Lead Sponsor

Trials

3

Recruited

40+

Case Comprehensive Cancer Center

Collaborator

Trials

472

Recruited

33,400+