Antithymocyte Globulin, Clofarabine, and Rituximab in Treating Patients After an Unsuccessful Stem Cell Transplant
NCT00617929 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2017-12-28
Summary
RATIONALE: Antithymocyte globulin, clofarabine, and rituximab may stop the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving antithymocyte globulin together with clofarabine and rituximab works in treating patients after an unsuccessful stem cell transplant.
Conditions
Interventions
- BIOLOGICAL
-
anti-thymocyte globulin
administer 3 mg/kg intravenously (IV) over 4 hours on days -6, -5 and -4.
- BIOLOGICAL
-
administered 375 mg/m\^2 intravenously (IV) in 1 mg/mL normal saline on day -7.
- DRUG
-
clofarabine
administered 30 mg/m\^2 intravenously (IV) over 1 hour on Days -4, -3, and -2.
- PROCEDURE
-
stem cell transplantation
administered on Day 0 per institutional guidelines.
Sponsors & Collaborators
-
Masonic Cancer Center, University of Minnesota
lead OTHER
Principal Investigators
-
Jakub Tolar, MD · Masonic Cancer Center, University of Minnesota
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-01-31
- Primary Completion
- 2014-10-31
- Completion
- 2015-10-31
Countries
- United States
Study Locations
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