A Phase 2 interventional study of cyclophosphamide and cyclosporine in Chronic Myeloproliferative Disorders, Leukemia and Myelodysplastic/Myeloproliferative Diseases, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Terminated at 1 site in United States. Open to participants aged 10 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-05-01.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Phase 2, Interventional, and Treatment
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well peripheral stem cell transplant works in treating patients with high-risk leukemia.
OBJECTIVES:
OUTLINE: This is a pilot study.
Patients receive a preparative regimen comprising total lymphoid irradiation once daily on days -13 to -11; cyclophosphamide IV over 1 hour on days -8 and -7; thiotepa IV over 4 hours every 12 hours on day -6; fludarabine IV over 30 minutes on days -5 to -1; and total body irradiation once on day -1. Patients also receive cyclosporine IV over 12 hours on days -8 to -1 and methylprednisolone IV twice daily on days -3 and -2. Patients receive CD34-enriched T-cell-depleted allogeneic stem cell infusion on day 0.
Patients with disease progression or uncontrolled infection but without grade II or greater graft-versus-host disease may receive up to 3 donor lymphocyte infusions at least 4 weeks apart until disease regression.
Patients are followed at least weekly until day 100 and then at 6, 12, 18, 24, 36, and 48 months.
PROJECTED ACCRUAL: A total of 20-51 patients will be accrued for this study.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 51 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
High-risk myelodysplastic syndromes (MDS), meeting 1 of the following criteria:
Acute myeloid leukemia (AML), meeting 1 of the following criteria :
High-risk AML in first remission and meeting 1 of the following criteria:
Chronic myelogenous leukemia, meeting 1 of the following criteria:
Myeloproliferative disease
The following diagnoses are eligible:
Acute lymphocytic leukemia (ALL), meeting 1 of the following criteria:
High-risk ALL in first remission defined by 1 of the following:
Availability of an HLA-mismatched family donor
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Incidence of graft failure 100 days post-transplant
Incidence of acute and chronic graft-vs-host disease100 days post-transplant
Transplant-related mortality 100 days post-transplant
Disease-free survival 100 days post-transplant
Overall survival 100 days post-transplant
This study is terminated, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.
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National Heart, Lung, and Blood Institute (NHLBI)