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Alkylating agents

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

Phase 1 & 2
Waitlist Available
Led By Deepa Jagadeesh, MD, MPH
Research Sponsored by Deepa Jagadeesh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
extranodal sites ≥ 2
- Creatinine clearance ≥45 mL/min calculated by Cockcroft-Gault or 24 hour collection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months (3 years) after completion of therapy or until death, whichever comes first
Awards & highlights

Study Summary

This trial is testing whether ME-401 can help treat diffuse large B-cell lymphoma (DLBCL). Standard treatment (R-CHOP) can cure many patients, but the cancer returns in about half of them. The trial will combine ME-401 with R-CHOP. Part 1 (phase I) will find the safest dose of ME-401 to use. Part 2 (phase 2) will use that dose to see if it decreases the rate of cancer recurrence.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include reactions similar to other chemotherapies such as nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts. Specific side effects from ME-401 aren't detailed but may be similar to other drugs in its class like diarrhea or liver enzyme elevations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread to two or more areas outside the lymph nodes.
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My kidneys are functioning well enough, with a creatinine clearance of at least 45 mL/min.
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My cancer has spread to more than one area outside of the lymph nodes.
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I have a tumor that can be measured on scans.
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I need assistance with my daily activities.
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My lymphoma is at an advanced stage (III or IV).
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My heart pumps well, with an ejection fraction of 50% or higher.
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My cancer is in an advanced stage (Stage III or IV).
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I am 60 years old or older.
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I need assistance with my daily activities due to my health condition.
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I have not been treated with PI3K or BTK inhibitors.
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I am 60 years old or older.
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My lymphoma has changed from a slow-growing type to a more aggressive form.
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My kidneys are functioning well enough for treatment.
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My lymphoma has changed from a slow-growing type to a more aggressive form.
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My heart pumps well, with an ejection fraction of 50% or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months (3 years) after completion of therapy or until death, whichever comes first
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months (3 years) after completion of therapy or until death, whichever comes first for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of clinically significant non-hematologic grade 3 or 4 treatment-related AEs or hematologic grade 3 or 4 treatment related AEs
Progression free survival (PFS) assessed by Lugano criteria
Secondary outcome measures
Complete Response (CR) assessed by Lugano criteria
Duration of Response (DoR)
Number of days treatment is delayed
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ME-401 + R-CHOPExperimental Treatment6 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Cyclophosphamide
1995
Completed Phase 3
~3770
Doxorubicin
2012
Completed Phase 3
~7940
Vincristine
2003
Completed Phase 4
~2910
Prednisone
2014
Completed Phase 4
~2370

Find a Location

Who is running the clinical trial?

Deepa JagadeeshLead Sponsor
2 Previous Clinical Trials
34 Total Patients Enrolled
Case Comprehensive Cancer CenterOTHER
452 Previous Clinical Trials
31,897 Total Patients Enrolled
Deepa Jagadeesh, MD, MPH5.01 ReviewsPrincipal Investigator - Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
3 Previous Clinical Trials
34 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04517435 — Phase 1 & 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04517435 — Phase 1 & 2
Non-Hodgkin's Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04517435 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: ME-401 + R-CHOP

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are enrolled in this clinical trial?

"That is correct, the trial information available on clinicaltrials.gov does show that the study investigators are currently looking for participants. The 54 patients needed for this trial will be recruited from a single location."

Answered by AI

Are there any more patients being accepted into this trial?

"This research is currently looking for individuals that fit the study's requirements. The listing was first put on clinicaltrials.gov on April 28th, 2021 and updated February 2nd, 2022."

Answered by AI

How is ME-401 most commonly used?

"ME-401 is most commonly used to target and treat lung cancer, but it can also be employed against other conditions such as small cell lung cancer (sclc), thyroiditis, or polyangium."

Answered by AI

What other research studies have there been on ME-401?

"As of right now, there are a total of 1483 different clinical trials underway that are researching ME-401. Of these studies, 317 have progressed to Phase 3 testing. Even though the majority of research for ME-401 is based in Bethesda, Maryland, there are 51872 locations where studies related to ME-401 are taking place."

Answered by AI

What do researchers hope to learn from this study?

"The primary goal of this trial, which will be measured over a 24 month period after treatment, is progression-free survival as assessed by the Lugano criteria. Additionally, researchers are looking at secondary outcomes including duration of response and time to treatment failure."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma
Deepa Jagadeesh 2021. "ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04517435.
~1 spots leftby Jul 2024
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