A Phase 1 interventional study of alemtuzumab and therapeutic allogeneic lymphocytes in Chronic Myeloproliferative Disorders, Leukemia and Lymphoma, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-12-15.
Sponsored by Yale University · Phase 1, Interventional, and Treatment
RATIONALE: Giving low doses of chemotherapy before a donor 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 that have been treated in the laboratory 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 tacrolimus before and after transplant may stop this from happening.
PURPOSE: This phase I trial is studying the side effects and best dose of donor lymphocytes when given after alemtuzumab and combination chemotherapy in treating patients who are undergoing donor stem cell transplant for hematologic cancer.
OBJECTIVES:
OUTLINE: This is a dose-escalation study of LMB-2 immunotoxin-treated, selectively-depleted donor T cells.
Cohorts of 3-6 patients receive escalating dose of LMB-2 immunotoxin-treated, selectively-depleted donor T cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting-toxicity.
After completion of study treatment, patients are followed weekly for 100 days post-transplantation and then periodically for survival.
PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study.
5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematologic malignancies:
Chronic myelogenous leukemia
Acute myeloid leukemia, meeting any of the following criteria:
Chronic lymphocytic leukemia
High-grade non-Hodgkin's lymphoma
Myeloproliferative disorders
Myelodysplastic syndromes (MDS), including any of the following:
Partially-matched related family donor available
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Yale University