A Phase 1 interventional study of anti-thymocyte globulin and sargramostim in Leukemia, Lymphoma and Multiple Myeloma and Plasma Cell Neoplasm, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-10-12.
Sponsored by University of California, San Francisco · Phase 1, Interventional, and Treatment
RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant helps stop both the growth of cancer cells and the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving chemotherapy, such as fludarabine and busulfan, and antithymocyte globulin before transplant and tacrolimus and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well giving low-dose fludarabine and busulfan together with anti-thymocyte globulin, followed by donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.
This study's enrollment of 7 is below the median of 38 across 4,268 interventional studies indexed under Leukemia.
Browse Leukemia studies →University of California, San Francisco is the lead sponsor of 2,164 studies on the registry; 368 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 199 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following advanced hematologic malignancies:
Acute myeloid leukemia (AML) meeting the following criteria:
Meets any of the following criteria:
Myelodysplastic syndromes (MDS) meeting the following criteria:
Must have high-risk features, including any of the following:
Acute lymphoblastic leukemia meeting the following criteria:
Meets any of the following criteria:
Chronic myelogenous leukemia (CML) meeting 1 of the following criteria:
Accelerated phase CML meeting 1 of the following criteria:
Multiple myeloma meeting the following criteria:
Meets any of the following criteria:
Lymphoma
The following subtypes are eligible:
Low-grade non-Hodgkin's lymphoma meeting 1 of the following criteria:
Chronic lymphocytic leukemia
Meets 1 of the following criteria:
Under age 55 and deemed ineligible for conventional high-dose chemotherapy, as indicated by any of the following:
Umbilical cord blood donor available
PATIENT CHARACTERISTICS:
Hepatitis C or active hepatitis B virus (HBV) allowed if ≤ grade 2 fibrosis and/or inflammation by liver biopsy
PRIOR CONCURRENT THERAPY:
Biological: anti-thymocyte globulin · Biological: sargramostim · Drug: busulfan · Drug: fludarabine phosphate · Drug: mycophenolate mofetil · Drug: tacrolimus · Procedure: umbilical cord blood transplantation
Safety and Feasibility of donor cord blood transplant
as determined by \> 80% engraftment rate at day 180 and a \< 50% transplant-related mortality rate at day 100
Time frame: up to 36 months post transplant
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Antilymphocyte Serum · Busulfan · Fludarabine phosphate
University of California, San Francisco →