Description:
Evaluation of impact of metformin on 2 year progression-free survival (PFS) rate in subjects with previously untreated DLBCL when added to standard induction therapy. (R-CHOP)
Clinical Trials /
Metformin in Combination With Standard Induction Therapy for Large B-cell Lymphoma (DLBCL)
NCT02531308
Related Conditions:
- Diffuse Large B-Cell Lymphoma
Recruiting Status:
Terminated
Phase:
Phase 2
Trial Eligibility
Document
Title
- Brief Title: Metformin in Combination With Standard Induction Therapy for Large B-cell Lymphoma (DLBCL)
- Official Title: A Phase ll Study Evaluating the Efficacy and Safety of Metformin in Combination With Standard Induction Therapy (RM-CHOP) for Previously Untreated Aggressive Diffuse Large B-cell Lymphoma
Clinical Trial IDs
- ORG STUDY ID: LYM2014-MET-R-CHOP
- NCT ID: NCT02531308
Conditions
- Diffuse Large B-Cell Lymphoma
Interventions
| Drug | Synonyms | Arms |
|---|---|---|
| Metformin | Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet. | R-CHOP with Metformin |
| Rituximab | Rituxan, Zytux, Mab thera | R-CHOP with Metformin |
| Cyclophosphamide | Endoxan, Cytoxan, Neosar, Procytox, Revimmune, Cycloblastin | R-CHOP with Metformin |
| Doxorubicin | Adriamycin | R-CHOP with Metformin |
| Vincristine | Oncovin | R-CHOP with Metformin |
| Prednisone | Deltasone | R-CHOP with Metformin |
| pegfilgrastim | Neulasta | R-CHOP with Metformin |
Purpose
Evaluation of impact of metformin on 2 year progression-free survival (PFS) rate in subjects
with previously untreated DLBCL when added to standard induction therapy. (R-CHOP)
Detailed Description
Newly diagnosed histologically confirmed CD20 positive previously untreated diffuse large
B-cell lymphoma to receive up to 4-6 cycles (21 day cycles) of:
R-CHOP: 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 IV Day 1 (cap @ 2mg) Prednisone 100mg PO daily Days
1-5 Pegfilgrastim 6 mg subcutaneously within 72 if start if cycle Metformin 500 mg PO daily
Cycle 1 Days 1-7 Metformin 500 mg PO twice daily Cycle 1 Days 7-21 Metformin 850 mg PO twice
daily starting on day 22 and and continuing throughout remainder of cycles plus 22 days post
treatment.
Restaging will be done after the 4th cycle is complete. Subjects will be monitored with labs
and physical exams throughout the study.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| R-CHOP with Metformin | Experimental | 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. |
|
Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of Diffuse Large B-cell Lymphoma (DLBCL) as documented by medical records
and with histology based on criteria established by the World Health Organization
a. subtyping is required for DLBCL
2. No prior therapy for diagnosis of DLBCL
3. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid
malignancy (defined as the presence of equal to or greater than 1 lesion that measures
>1.5 cm in the longest diameter and > 1.0 cm in the longest perpendicular diameter
assessed by CT or MRI) or bone marrow involvement
4. Eastern Cooperative Oncology Group performance score of 0-2
5. Life expectancy of at least 6 months
6. No history of medication dependent diabetes mellitus
7. Required screening laboratory data (within 4 weeks prior to start of study drug) -
Exclusion Criteria:
1. Patients already on any class of anti-diabetic medication including metformin, insulin
analogues, sulfonylureas, thiazolidinediones (TZDs) and the incretin-based therapies
or clear need for therapeutic intervention based on fasting blood glucose
2. Known histological transformation from indolent non-Hodgkins Lymphoma (NHL) or chronic
lymphocytic leukemia (CLL) to an aggressive form of NHL (ie, Richter transformation)
3. Double or triple hit lymphomas
4. Known active cent4ral nervous system or leptomeningeal lymphoma
5. Presence of known intermediate or high-grade myelodysplastic syndrome
6. History of a non-lymphoid malignancy within the last 3 years (see protocol for
exceptions)
7. Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of
start of study
8. Ongoing, drug-induced liver injury, chronic active Hepatitis C Virus (HCV), chronic
active Hepatitis B Virus (HBV), alcoholic liver disease, non-alcoholic
steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by
cholelithiasis, cirrhosis of the liver, or portal hypertension.
9. HIV positive
10. Ongoing inflammatory bowel disease
11. Ongoing alcohol or drug addiction
12. Pregnancy
13. History of prior allogeneic bone marrow progenitor cell or solid organ
transplantation.
-
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Progression Free Survival |
| Time Frame: | 2 year |
| Safety Issue: | |
| Description: | rate of progression in patients 2 years after diagonosis |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | Rush University Medical Center |
Trial Keywords
- diffuse large b-cell lymphoma (DLBCL),
- lymphoma
Last Updated
January 27, 2017
