An interventional study of anti-thymocyte globulin and filgrastim in Chronic Myeloproliferative Disorders, Leukemia and Lymphoma, sponsored by University of California, San Francisco. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-10-04.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this 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 methotrexate and tacrolimus after the transplant may stop this from happening.
PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in treating older or frail patients with hematologic cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of study therapy, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 25 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of a high-risk indolent hematologic malignancy meeting the following criteria:
Chronic lymphocytic leukemia (CLL) meeting 1 of the following criteria:
Non-Hodgkin's lymphoma (NHL) meeting 1 of the following criteria:
Low-grade NHL meeting 1 of the following criteria:
In first or subsequent remission with adverse International Prognostic Index (IPI) prognostic features, as defined by the presence of ≥ 3 of the following:
Intermediate- or high-grade NHL meeting 1 of the following criteria:
Waldenstrom's macroglobulinemia meeting 1 of the following criteria:
Multiple myeloma meeting 1 of the following criteria:
Myeloproliferative disorders, including any of the following:
Prolymphocytic leukemia meeting 1 of the following criteria:
Mantle cell lymphoma meeting 1 of the following criteria:
Hodgkin's lymphoma meeting the following criteria:
In second or subsequent remission
Myelodysplastic syndromes (MDS) meeting 1 of the following criteria:
In CR or partial remission or stabilization of disease after standard chemotherapy
Meets 1 of the following criteria:
Younger patients with any of the following comorbidities:
Sibling or related donor available
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Biological: anti-thymocyte globulin · Biological: filgrastim · Biological: therapeutic allogeneic lymphocytes · Drug: busulfan · Drug: fludarabine phosphate · Drug: methotrexate · Drug: tacrolimus · Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation · Procedure: peripheral blood stem cell transplantation
Toxicity and survival
Time frame: up to 36 months post transplant
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco