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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00066417 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders Leukemia Myelodysplastic/Myeloproliferative Diseases |
Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: methylprednisolone Drug: therapeutic allogeneic lymphocytes Drug: thiotepa Procedure: allogeneic bone marrow transplantation Procedure: biological therapy Procedure: bone marrow ablation with stem cell support Procedure: bone marrow transplantation Procedure: chemotherapy Procedure: leukocyte therapy Procedure: non-specific immune-modulator therapy Procedure: peripheral blood lymphocyte therapy Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Pilot Study Of T-Cell-Depleted Peripheral Blood Stem Cell Transplantation From Partially Matched Related Donors For Patients With High-Risk Leukemia |
| Estimated Enrollment: | 51 |
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.
Eligibility| Ages Eligible for Study: | 10 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Maryland | |
| NIH - Warren Grant Magnuson Clinical Center | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Bipin N. Savani, MD | National Heart, Lung, and Blood Institute (NHLBI) |
More Information
| Study ID Numbers: | CDR0000315900, NHLBI-03-H-0209 |
| Study First Received: | August 6, 2003 |
| Last Updated: | January 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00066417 History of Changes |
| Health Authority: | Unspecified |
|
essential thrombocythemia polycythemia vera blastic phase chronic myelogenous leukemia secondary myelodysplastic syndromes previously treated myelodysplastic syndromes adult acute myeloid leukemia in remission childhood acute myeloid leukemia in remission de novo myelodysplastic syndromes secondary acute myeloid leukemia accelerated phase chronic myelogenous leukemia childhood chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission |
childhood acute lymphoblastic leukemia in remission recurrent adult acute myeloid leukemia relapsing chronic myelogenous leukemia recurrent childhood acute myeloid leukemia chronic idiopathic myelofibrosis atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with t(15;17)(q22;q12) |
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Anti-Inflammatory Agents Anti-Infective Agents Cyclosporine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Cyclosporins Hormones Therapeutic Uses Dermatologic Agents Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal |
Hematologic Diseases Myeloproliferative Disorders Glucocorticoids Thiotepa Neoplasms Fludarabine Antimetabolites Vidarabine Immunologic Factors Antineoplastic Agents Prednisolone acetate Cyclophosphamide Neuroprotective Agents Leukemia Antifungal Agents |