Trial Outcomes & Findings for Metformin in Combination With Standard Induction Therapy for Large B-cell Lymphoma (DLBCL) (NCT NCT02531308)

Results Overview

rate of progression in patients 2 years after diagnosis

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

2 year

Results posted on

2022-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	R-CHOP With Metformin Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study. Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study. Metformin: Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells. Rituximab: monoclonal antibody against protein CD20 Cyclophosphamide: Interferes with DNA replication Doxorubicin: anthracycline antitumor antibiotic Vincristine: Inhibits cell mitosis causing cell death. Prednisone: a synthetic cortic
Overall Study STARTED	5
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Metformin in Combination With Standard Induction Therapy for Large B-cell Lymphoma (DLBCL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	R-CHOP With Metformin n=5 Participants Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study. Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 year

Population: The primary endpoint (2 year PFS rate) could not be determined as study was terminated prematurely prior to subjects reaching this milestone with confidentiality of concern for reporting collected data.

rate of progression in patients 2 years after diagnosis

Outcome measures

Outcome data not reported

Adverse Events

R-CHOP With Metformin

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	R-CHOP With Metformin n=5 participants at risk Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study. Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study. Metformin: Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells. Rituximab: monoclonal antibody against protein CD20 Cyclophosphamide: Interferes with DNA replication Doxorubicin: anthracycline antitumor antibiotic Vincristine: Inhibits cell mitosis causing cell death. Prednisone: a synthetic cortic
Infections and infestations Fever with urosepsis	20.0% 1/5 • Number of events 2
Vascular disorders Pulmonary Embolism and DVT	20.0% 1/5 • Number of events 1

Other adverse events

Other adverse events
Measure	R-CHOP With Metformin n=5 participants at risk Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study. Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study. Metformin: Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells. Rituximab: monoclonal antibody against protein CD20 Cyclophosphamide: Interferes with DNA replication Doxorubicin: anthracycline antitumor antibiotic Vincristine: Inhibits cell mitosis causing cell death. Prednisone: a synthetic cortic
General disorders fatigue	100.0% 5/5 • Number of events 5
Endocrine disorders hypoglycemia	20.0% 1/5 • Number of events 1
Blood and lymphatic system disorders anemia	80.0% 4/5
Blood and lymphatic system disorders thrombocytopenia	40.0% 2/5
Blood and lymphatic system disorders neutropenia	60.0% 3/5
Cardiac disorders cardiomyopathy	40.0% 2/5

Additional Information

Dr. R Karmali

Northwestern University

Phone: 312-695-0686

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place