Trial Outcomes & Findings for ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma (NCT NCT04517435)

Last Updated: 2025-02-07

Results Overview

Dose limiting toxicity (DLT) as defined by non-hematologic clinically significant grade 3 or 4 treatment-related AEs or hematologic grade 3 or 4 treatment related AEs that are clinically significant during the first cycle, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Up to 24 months after treatment

Results posted on

2025-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	Phase I: ME-401 + R-CHOP Dose Level 1 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) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 2 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase II: 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.
Overall Study STARTED	3	6	4
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	3	6	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I: ME-401 + R-CHOP Dose Level 1 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) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 2 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase II: 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.
Overall Study Withdrawal by Subject	0	0	1
Overall Study Pharmaceutical company discontinued the trial	3	6	3

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to 24 months after treatment

Population: Per the protocol, this outcome measure specifically pertains to Phase I and, therefore, does not include Phase II participants. All Phase I participants were analyzed for this outcome. This clinical trial was terminated prematurely due to MEI Pharma's withdrawal of funding, which included discontinuation of participant follow-up. This analysis is based on limited data collected prior to discontinuation before reaching the intended endpoint.

Outcome measures

Outcome measures
Measure	Phase II: 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 1 n=3 Participants 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) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 2 n=6 Participants 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.
Phase I: Number of Clinically Significant Non-hematologic Grade 3 or 4 Treatment-related AEs or Hematologic Grade 3 or 4 Treatment Related AEs	—	2 Adverse events	3 Adverse events

PRIMARY outcome

Timeframe: 24 months (2 years)

Population: This clinical trial was terminated prematurely due to MEI Pharma's withdrawal of funding, which included discontinuation of participant follow-up. This analysis is based on limited data collected prior to discontinuation before reaching the intended endpoint. One participant in Phase II did not meet the protocol criteria for outcome analysis and is therefore excluded from this analysis.

PFS, as defined as time from study treatment initiation to documented disease progression per Lugano Criteria, or death from any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Phase II: ME-401 + R-CHOP n=3 Participants 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 1 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) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 2 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.
Phase II: Progression Free Survival (PFS) Assessed by Lugano Criteria	5 months Interval 5.0 to 5.0	—	—

SECONDARY outcome

Timeframe: Up to 24 months after treatment

Population: Per the protocol, this outcome measure pertains to Phase I and does not include Phase II participants. All Phase I participants were analyzed for this outcome. This clinical trial was terminated prematurely due to MEI Pharma's withdrawal of funding, which included discontinuation of participant follow-up. This analysis is based on limited data collected prior to discontinuation before reaching the intended endpoint.

Number of treatment-related AEs in Phase I. Participants will be followed for toxicity for 30 days after treatment has been discontinued or until death, whichever occurs first. The clinical course of each event will be followed until resolution, stabilization, or until it has been determined that the study treatment or participation is not the cause with a cut off of 24 months after completion of therapy.

Outcome measures

Outcome measures
Measure	Phase II: 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 1 n=3 Participants 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) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 2 n=6 Participants 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.
Phase I: Number of Treatment-related AEs	—	7 adverse events	18 adverse events

SECONDARY outcome

Timeframe: Up to 24 months after treatment

Population: Per the protocol, this outcome measure pertains to Phase II and does not include Phase I participants. All Phase II participants were analyzed for this outcome. This clinical trial was terminated prematurely due to MEI Pharma's withdrawal of funding, which included discontinuation of participant follow-up. This analysis is based on limited data collected prior to discontinuation before reaching the intended endpoint.

Number of treatment-related AEs in Phase II Participants will be followed for toxicity for 30 days after treatment has been discontinued or until death, whichever occurs first. The clinical course of each event will be followed until resolution, stabilization, or until it has been determined that the study treatment or participation is not the cause with a cut off of 24 months after completion of therapy.

Outcome measures

Outcome measures
Measure	Phase II: ME-401 + R-CHOP n=3 Participants 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 1 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) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 2 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.
Phase II: Number of Treatment-related AEs	22 treatment related adverse events	—	—

SECONDARY outcome

Timeframe: Up to 24 months after treatment

Number of days treatment is delayed

Outcome measures

Outcome measures
Measure	Phase II: ME-401 + R-CHOP n=3 Participants 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 1 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) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 2 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.
Phase II: Number of Days Treatment is Delayed	0 days Standard Deviation 0	—	—

SECONDARY outcome

Timeframe: 24 months (2 years)

Population: Per the protocol, this outcome measure pertains to Phase II and does not include Phase I participants. One participant in Phase II did not meet the protocol criteria for outcome analysis and is therefore excluded from this analysis. This clinical trial was terminated prematurely due to MEI Pharma's withdrawal of funding, which included discontinuation of participant follow-up. This analysis is based on limited data collected prior to discontinuation before reaching the intended endpoint.

OR assessed by Lugano criteria. OR is defined as achieving either CR or PR at any stage from time of commencement of protocol treatment to time of treatment cessation for whatever reason

Outcome measures

Outcome measures
Measure	Phase II: ME-401 + R-CHOP n=3 Participants 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 1 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) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 2 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.
Phase II: Overall Response (OR) Assessed by Lugano Criteria	3 Participants	—	—

SECONDARY outcome

Timeframe: 24 months (2 years)

CR assessed by Lugano criteria

Outcome measures

Outcome measures
Measure	Phase II: ME-401 + R-CHOP n=3 Participants 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 1 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) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 2 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.
Complete Response (CR) Assessed by Lugano Criteria	2 Participants	—	—

SECONDARY outcome

Timeframe: 24 months (2 years)

PR assessed by Lugano criteria

Outcome measures

Outcome measures
Measure	Phase II: ME-401 + R-CHOP n=3 Participants 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 1 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) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 2 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.
Partial Response (PR) Assessed by Lugano Criteria	1 Participants	—	—

SECONDARY outcome

Timeframe: 24 months (2 years)

Population: Per the protocol, this outcome measure pertains to Phase II and does not include Phase I participants. One participant in Phase II did not meet the protocol criteria for outcome analysis and is therefore excluded from this analysis. This clinical trial was terminated prematurely due to MEI Pharma's withdrawal of funding, which included discontinuation of follow-up. This analysis is based on limited data (the average time from the participant's best response until discontinuation of follow-up).

DoR defined as the time from documented response (CR or PR) to the time of confirmed disease progression or death due to any cause, whichever occurs first

Outcome measures

Outcome measures
Measure	Phase II: ME-401 + R-CHOP n=3 Participants 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 1 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) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 2 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.
Phase II: Duration of Response (DoR)	1 months Interval 0.0 to 2.0	—	—

SECONDARY outcome

Timeframe: 24 months (2 years)

OS defined as the time from first dose of study treatment to death from any cause

Outcome measures

Outcome measures
Measure	Phase II: ME-401 + R-CHOP n=3 Participants 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 1 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) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 2 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.
Phase II: Overall Survival (OS)	5 months Interval 5.0 to 5.0	—	—

SECONDARY outcome

Timeframe: 24 months (2 years)

Time to Treatment Failure defined as the time from study entry to any treatment failure.

Outcome measures

Outcome measures
Measure	Phase II: ME-401 + R-CHOP n=3 Participants 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 1 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) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 2 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.
Phase II: Time to Treatment Failure	5 months Interval 5.0 to 5.0	—	—

Adverse Events

Phase I: ME-401 + R-CHOP Dose Level 1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase I: ME-401 + R-CHOP Dose Level 2

Serious events: 6 serious events

Other events: 6 other events

Deaths: 0 deaths

Phase II: ME-401 + R-CHOP

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase I: ME-401 + R-CHOP Dose Level 1 n=3 participants at risk 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) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 2 n=6 participants at risk 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase II: ME-401 + R-CHOP n=4 participants at risk 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.
Gastrointestinal disorders Jejunal Perforation	0.00% 0/3 • 24 months (2 years)	16.7% 1/6 • 24 months (2 years)	0.00% 0/4 • 24 months (2 years)
Investigations Neutrophil count decreased	33.3% 1/3 • 24 months (2 years)	16.7% 1/6 • 24 months (2 years)	0.00% 0/4 • 24 months (2 years)
Investigations White blood cell count decreased	33.3% 1/3 • 24 months (2 years)	33.3% 2/6 • 24 months (2 years)	0.00% 0/4 • 24 months (2 years)
Infections and infestations Lung Infection	0.00% 0/3 • 24 months (2 years)	16.7% 1/6 • 24 months (2 years)	0.00% 0/4 • 24 months (2 years)
Investigations Lymphocyte count decreased	0.00% 0/3 • 24 months (2 years)	16.7% 1/6 • 24 months (2 years)	0.00% 0/4 • 24 months (2 years)
Gastrointestinal disorders Colonic obstruction	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Gastrointestinal disorders Colitis	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Blood and lymphatic system disorders Anemia	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)

Other adverse events

Other adverse events
Measure	Phase I: ME-401 + R-CHOP Dose Level 1 n=3 participants at risk 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) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 2 n=6 participants at risk 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase II: ME-401 + R-CHOP n=4 participants at risk 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.
Blood and lymphatic system disorders Anemia	33.3% 1/3 • 24 months (2 years)	16.7% 1/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Gastrointestinal disorders Constipation	0.00% 0/3 • 24 months (2 years)	16.7% 1/6 • 24 months (2 years)	50.0% 2/4 • 24 months (2 years)
Gastrointestinal disorders Diarrhea	33.3% 1/3 • 24 months (2 years)	33.3% 2/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Gastrointestinal disorders Nausea	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
General disorders Fatigue	0.00% 0/3 • 24 months (2 years)	33.3% 2/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Investigations Neutrophil count decreased	33.3% 1/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	0.00% 0/4 • 24 months (2 years)
Investigations White blood cell count decreased	33.3% 1/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	0.00% 0/4 • 24 months (2 years)
Investigations Platelet count decreased	0.00% 0/3 • 24 months (2 years)	33.3% 2/6 • 24 months (2 years)	0.00% 0/4 • 24 months (2 years)
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/3 • 24 months (2 years)	16.7% 1/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • 24 months (2 years)	16.7% 1/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • 24 months (2 years)	16.7% 1/6 • 24 months (2 years)	0.00% 0/4 • 24 months (2 years)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • 24 months (2 years)	16.7% 1/6 • 24 months (2 years)	0.00% 0/4 • 24 months (2 years)
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • 24 months (2 years)	16.7% 1/6 • 24 months (2 years)	0.00% 0/4 • 24 months (2 years)
Nervous system disorders Peripheral sensory neuropathy	33.3% 1/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	0.00% 0/4 • 24 months (2 years)
Nervous system disorders Dizziness	0.00% 0/3 • 24 months (2 years)	16.7% 1/6 • 24 months (2 years)	0.00% 0/4 • 24 months (2 years)
Nervous system disorders Dysphasia	33.3% 1/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	0.00% 0/4 • 24 months (2 years)
Skin and subcutaneous tissue disorders Alopecia	33.3% 1/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Vascular disorders Thromboembolic event	0.00% 0/3 • 24 months (2 years)	16.7% 1/6 • 24 months (2 years)	0.00% 0/4 • 24 months (2 years)
Gastrointestinal disorders Colitis	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Gastrointestinal disorders Dry mouth	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Gastrointestinal disorders Mucositis oral	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Investigations Aspartate aminotransferase increased	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Investigations Alkaline phosphatase increased	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Investigations Lipase increased	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Nervous system disorders Dysgeusia	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Infections and infestations Upper respiratory infection	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • 24 months (2 years)	0.00% 0/6 • 24 months (2 years)	25.0% 1/4 • 24 months (2 years)

Additional Information

Dr. Deepa Jagadeesh

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Phone: 1-866-223 8100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Phase I: ME-401 + R-CHOP Dose Level 1 n=3 Participants 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) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase I: ME-401 + R-CHOP Dose Level 2 n=6 Participants 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Phase II: ME-401 + R-CHOP n=4 Participants 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 1-7 (dose level 2) of a 21 day cycle with standard dose R-CHOP x 6 cycles.	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	6 participants n=7 Participants	4 participants n=5 Participants	13 participants n=4 Participants