Sapacitabine, Cyclophosphamide, Rituximab for Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (CLL/SLL) With Deletion (11q22-23)

PHASE2TerminatedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

August 22, 2011

Primary Completion Date

March 28, 2018

Study Completion Date

February 13, 2019

Conditions
Leukemia
Interventions
DRUG

Cyclophosphamide

250 mg/m2 by vein (IV) over 30 minutes, 2 hours following the dose of Sapacitabine on days 1, 2, and 3 of each 28 day course.

DRUG

Rituximab

375 mg/m2 by vein over 6 - 8 hours on day 3 of course 1 after cyclophosphamide, then at 500 mg/m2 on day 1, after cyclophosphamide for subsequent courses. Each course is 28 days.

DRUG

Sapacitabine

350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors
All Listed Sponsors
collaborator

Cyclacel Pharmaceuticals, Inc.

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

M.D. Anderson Cancer Center

OTHER

NCT01253460 - Sapacitabine, Cyclophosphamide, Rituximab for Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma (CLL/SLL) With Deletion (11q22-23) | Biotech Hunter | Biotech Hunter