Non-Myeloablative Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Treatment of Hematologic Malignancies, Renal Cell Carcinoma, and Aplastic Anemia

University of California, San Francisco1 site in 1 country44 target enrollmentOctober 2001

ConditionsAcute Myeloid Leukemia Myelodysplasia Acute Lymphoblastic Leukemia Chronic Lymphocytic Leukemia Follicular Lymphoma Multiple Myeloma NHL Myeloproliferative Diseases Chronic Myeloid Leukemia Renal Cell Carcinoma Aplastic Anemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Myeloid Leukemia
Sponsor: University of California, San Francisco
Enrollment: 44
Locations: 1
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to examine transplant related mortality (TRM) at 100 days <30%. A TRM of >50% is considered unacceptable. This study also seeks a TRM at 12 months that is <50%, engraftment >90% (defined as donor cells >80% at 6 months), and 1 year overall survival >50%.

Registry

clinicaltrials.gov

Start Date

October 2001

End Date

November 2007

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of California, San Francisco

Eligibility Criteria

Inclusion Criteria

•\<75 years old
•Availability of suitable matched unrelated donor. We will require HLA matching at 9 of 10 loci including HLA A, B, C, DR and DQ. For patients treated at UCSF, typing will be done in the UCSF Immunogenetics Department. Typing will be done by high-resolution techniques at the allele level. Donors will be recruited through the National Marrow Donor Program (NMDP). Donors must meet the standards of NMDP as well as Institutional standards for donors at the center for which they are being collected.
•Disease must be stable or responding to therapy. The expected time to disease progression should be greater than 12 weeks.
•Disease types include:
•Acute myeloid leukemia not expected to be curable with chemotherapy. This will include patients with high-risk cytogenetics (-7, -7q, -5, -5q, complex, Ph+), evolution from prior myelodysplasia or AML secondary to prior chemotherapy, failure to achieve remission, or second or subsequent remission. To ensure adequate time until disease progression, marrow blasts must be \<10%. This may be achieved using chemotherapy treatment.
•Myelodysplasia with high-risk features. These will include adverse cytogenetics (-7, -7q, -5, -5q, complex), excess blasts, prior conversion to AML, or severe cytopenias, with ANC\<500uL or platelets \<20,000uL. Marrow blasts must be \<10%. This may be achieved using chemotherapy.
•Acute lymphoblastic leukemia not expected to be curable with chemotherapy. This will include patients with high-risk cytogenetics (Ph+, 11q23 abnormalities, and monosomy 7), patients requiring more than one induction course to achieve remission, as well as patients failing to enter remission or in second or subsequent remission. Marrow blasts must be \<10%.
•Chronic lymphocytic leukemia with high-risk features. This will include refractoriness to initial or subsequent therapy, progression after initial response to therapy, or prolymphocytic (PLL) morphology.
•Follicular lymphoma with high-risk features. This will include refractoriness to initial or subsequent therapy, progression after response to initial therapy, or \> or equal 3 IPI risk factors.
•Multiple myeloma, stage II-III. Patients are eligible either at diagnosis or after initial progression.

Exclusion Criteria

•Active infection requiring ongoing antibiotic treatment
•Poor performance status
•Rapid progression of malignant disease
•Opinion of BMT Committee that autologous transplant would be a preferable form of treatment
•Organ function below requirements
•Pregnancy