Trial Outcomes & Findings for DA-EPOCH-Rituximab/Metformin (RM) for Double Hit Lymphoma (NCT NCT02815397)

Results Overview

Progression-free survival determined by CT scans at 18 months

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

18 month

Results posted on

2017-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm, Open Label Metformin added to standard of care treatment for all patients Metformin: given in addition to standard of care treatment
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm, Open Label Metformin added to standard of care treatment for all patients Metformin: given in addition to standard of care treatment
Overall Study Physician Decision	2

Baseline Characteristics

DA-EPOCH-Rituximab/Metformin (RM) for Double Hit Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm, Open Label n=2 Participants Metformin added to standard of care treatment for all patients Metformin: given in addition to standard of care treatment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 18 month

Population: will not have this data as study closed prematurely.

Progression-free survival determined by CT scans at 18 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Population: no data available as study closed before response could be determined

Evaluation of the effect of the addition of metformin to induction chemotherapy on overall response rates

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Population: will not have this data as study closed prematurely.

Evaluation of the addition of metformin to standard induction therapy on 18 month overall survival

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Population: will not have this data as study closed prematurely.

Describe the safety profile observed by measuring fasting glucose and anion gap weekly through cycle 6.

Outcome measures

Outcome data not reported

Adverse Events

Single Arm, Open Label

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. R Karmali

Northwestern University

Phone: 312-695-6832

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place