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Phase I/II Trial of R-CHOP + Azacytidine in Diffuse Large B Cell Lymphoma

NCT01004991 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-04-10

Study results available
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Summary

This is a phase I/II open label, multi-center study of azacytidine in combination with standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on day 8, every 21 days. Patients will be treated for a total 6 cycles. The phase II portion will then evaluate efficacy of the combination at the established MTD.

Conditions

Interventions

BIOLOGICAL

rituximab

375 mg/m2 on Day 8 of each of 6 cycles

DRUG

cyclophosphamide

750 mg/m2 on Day 8 of each of 6 cycles

DRUG

vincristine

1.4 mg/m2 on Day 8 of each of 6 cycles

DRUG

doxorubicin

50 mg/m2 on Day 8 of each of 6 cycles

DRUG

prednisone

100 mg PO days 8-12 of each of 6 cycles

DRUG

azacytidine

Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Peter Martin, MD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-09-30
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01004991 on ClinicalTrials.gov