ME-401 + R-CHOP for Non-Hodgkin's Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for diffuse large B-cell lymphoma (DLBCL), a type of blood cancer that can recur after standard treatment. The trial combines a new drug, ME-401, with the usual treatment, R-CHOP, to determine if it can more effectively prevent cancer recurrence. The first part of the study identifies the safest dose of ME-401, while the second part tests whether this combination helps keep the cancer away. Individuals diagnosed with DLBCL, who have not previously received certain drugs and have measurable disease, might be suitable candidates for this trial. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that participants cannot be on other investigational agents or certain treatments like PI3K or BTK inhibitors. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that R-CHOP, which includes drugs like cyclophosphamide, doxorubicin, prednisone, rituximab, and vincristine, is generally safe and well-tolerated by patients with diffuse large B-cell lymphoma (DLBCL). Studies have found that R-CHOP improves survival rates compared to CHOP alone, with many patients experiencing positive results.
ME-401 is a newer treatment being tested with R-CHOP. In this trial's early stages, the main goal is to determine a safe dose of ME-401 to use with R-CHOP. Safety remains a top priority, and researchers closely monitor any side effects.
Although limited data exists on ME-401's safety, its testing in human trials suggests some confidence in its potential safety. Participants in these trials are carefully monitored to ensure their safety.12345Why do researchers think this study treatment might be promising for lymphoma?
Researchers are excited about the treatment combining ME-401 with R-CHOP for Non-Hodgkin's Lymphoma because it introduces a novel approach to enhance the effectiveness of the standard R-CHOP regimen. Unlike current treatments that mainly involve chemotherapy and immunotherapy, ME-401 is a PI3K delta inhibitor that targets a specific pathway involved in the growth and survival of cancer cells. By adding ME-401, the hope is to improve outcomes by directly interfering with cancer cell signaling, potentially leading to better response rates and prolonged remission for patients. This approach could offer a more targeted and potentially more effective option than the current standard therapies alone.
What evidence suggests that ME-401 combined with R-CHOP could be effective for treating diffuse large b-cell lymphoma?
Research has shown that R-CHOP, a common treatment for diffuse large B-cell lymphoma (DLBCL), greatly improves patient outcomes. It achieves a 5-year survival rate of about 58%, compared to 45% for CHOP alone. Studies also indicate that R-CHOP leads to a 2-year progression-free survival rate of around 75.5%. In this trial, participants will receive ME-401 in combination with R-CHOP. ME-401 is a promising new addition to this treatment. It blocks certain pathways that cancer cells use to grow and survive, which may help prevent the cancer from returning after treatment. Although limited data exists on using ME-401 with R-CHOP, its method of action suggests it could enhance R-CHOP's effectiveness in treating DLBCL.12346
Who Is on the Research Team?
Deepa Jagadeesh
Principal Investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Participants receive ME-401 in combination with R-CHOP to determine the recommended phase 2 dose (RP2D) and assess tolerability
Phase II Treatment
Participants receive the RP2D of ME-401 in combination with R-CHOP to evaluate clinical activity and response rates
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of progression-free survival and treatment-related adverse events
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Deepa Jagadeesh
Lead Sponsor
Case Comprehensive Cancer Center
Collaborator
Citations
ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B ...
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 ...
Efficacy and safety of rituximab combined with ...
In patients with relapsed/resistant DLBCL, R-CHOP increased the 5-year overall survival of 58% compared with 45% for CHOP alone [8]. R-CHOP has modified the ...
3.
ashpublications.org
ashpublications.org/bloodadvances/article/5/4/984/475201/A-randomized-phase-2-3-study-of-R-CHOP-vs-CHOPA randomized phase 2/3 study of R-CHOP vs CHOP ...
The outcomes of the R-CHOP arm in these studies were 74.8% in 2-year PFS, 66.9% in 3-year PFS, 70.1% in 30-month PFS, and 75.5% in 2-year PFS, ...
Comparative efficacy of different chemotherapies for non- ...
This network meta-analysis (NMA) was conducted to integrate different chemotherapeutic regimens for non-Hodgkin lymphoma (NHL) patients.
5.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT04517435/me-401-and-r-chop-in-newly-diagnosed-diffuse-large-b-cell-lymphomaME-401 and R-CHOP in Newly Diagnosed Diffuse Large B ...
This study is being done to evaluate if ME-401 can improve the treatment of patients with diffuse large b-celllymphoma (DLBCL).
Revising the Treatment Pathways in Lymphoma
In the National LymphoCare study, the POD24 population (19%) had a 5-year OS of 50% compared with 90% in patients without early relapse. More ...
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