Status:
COMPLETED
Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD
Lead Sponsor:
Stanford University
Collaborating Sponsors:
The Leukemia and Lymphoma Society
National Cancer Institute (NCI)
Conditions:
Leukemia, Mast-Cell
Mantle-cell Lymphoma
Eligibility:
All Genders
18-76 years
Phase:
PHASE2
Brief Summary
To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)
Detailed Description
To test if prophylactic anti-B-cell therapy (weekly rituximab) given within 60 to 90 days after allogeneic transplantation will decrease allogeneic donor B-cell immunity and possibly the incidence of ...
Eligibility Criteria
Inclusion
- Recipient
- Between 18 and 76 years of age
- Chronic lymphocytic leukemia (CLL):
- Unmutated IgG VH gene status
- Mutated IgG VH genes (\> 2% nucleotide change compared to somatic sequence)
- Complete remission benefit most from allogeneic hematopoietic stem cell transplant (HSCT).
- (Physicians will be encouraged to provide aggressive chemotherapy prior to nonmyeloablative transplantation.)
- Mantle cell lymphoma (MCL): Transplant physicians believe subject would benefit from allogeneic HSCT.
- Adequate renal (Cr \< 2.4 mg/dL) and hepatic (Bilirubin \< 3.0 mg/dL, Aspartate aminotransferase (AST) \< 100 IU) function.
- Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
- All subjects must provide written informed consent
- Donor
- Genotypically or phenotypically human leukocyte antigen (HLA)-identical.
- Age \< 76 unless cleared by institutional PI
- Capable of giving written, informed consent.
- Must consent to peripheral blood stem cell (PBSC) mobilization with G-CSF and apheresis
- Recipient
Exclusion
- Recipient has a 9 of 10 or 10 of 10 HLA identical donor (high resolution molecular genotyping at HLA A, B, C and DrB1, and DQ)
- Pregnancy
- Lactating
- Serious uncontrolled infection
- HIV seropositivity
- Hepatitis B or C seropositivity
- Cardiac function: ejection fraction \< 40% or uncontrolled cardiac failure
- Pulmonary: Diffusing capacity - carbon monoxide (DLCO) \< 50% predicted
- Liver function abnormalities: elevation of bilirubin to ≥ 3 mg/dL and/or AST \> 100
- Renal: creatinine \> 2.4
- Karnofsky performance score ≤ 60%
- Patients with poorly controlled hypertension (systolic blood pressure \> 150 or diastolic blood pressure \> 90 repeatedly).
- Known life-threatening hypersensitivity to rituximab or other anti-B cell antibodies.
- Inability to comply with the allogeneic transplant treatment.
- Uncontrolled central nervous system (CNS) involvement with disease
- Donor
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00186628
Start Date
June 1 2005
End Date
December 1 2010
Last Update
November 28 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305