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| Sponsors and Collaborators: |
NCI - Center for Cancer Research-Medical Oncology National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00080925 |
Purpose
RATIONALE: Donor peripheral stem cell transplantation may be able to replace bone marrow and immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the body's normal cells. Eliminating the T cells from the donor cells before transplanting them and giving cyclosporine may prevent this from happening.
PURPOSE: This phase I trial is studying the side effects of T-cell-depleted allogeneic stem cell transplantation after immunoablative induction chemotherapy and reduced-intensity transplantation conditioning (chemotherapy) in treating patients with hematologic malignancies.
| Condition | Intervention | Phase |
|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cyclophosphamide Drug: cyclosporine Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: fludarabine phosphate Drug: prednisone Drug: rituximab Drug: therapeutic allogeneic lymphocytes Drug: vincristine sulfate Procedure: graft-versus-tumor induction therapy Procedure: peripheral blood stem cell transplantation |
Phase I |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | T-Cell Depleted, Reduced-Intensity Allogeneic Stem Cell Transplantation From Haploidentical Related Donors For Hematologic Malignancies |
Eligibility
| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematologic malignancies:
Acute myeloid leukemia (AML), meeting 1 of the following criteria:
In first complete remission (CR1), meeting 1 of the following criteria:
Adverse cytogenetics with minimal residual disease detectable by flow cytometry, cytogenetic analysis, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR), defined as 1 of the following:
Acute lymphoblastic leukemia, meeting 1 of the following criteria:
In CR1, meeting 1 of the following criteria:
Adverse cytogenetics with minimal residual disease detectable by flow cytometry, cytogenetic analysis, FISH, or PCR, defined as the following:
Myelodysplastic syndromes (MDS)
Chronic myelogenous leukemia (CML), meeting 1 of the following criteria:
Myeloproliferative disorders, meeting 1 of the following criteria:
Agnogenic myeloid metaplasia with adverse-risk features, meeting at least 2 of the following criteria:
Myelodysplastic/myeloproliferative disease
Hodgkin's lymphoma or non-Hodgkin's lymphoma
Chronic lymphocytic leukemia
Prolymphocytic leukemia (PLL), meeting 1 of the following criteria:
T-PLL
B-PLL
Multiple myeloma, meeting 1 of the following criteria:
Adverse cytogenetics, defined as 1 of the following:
Less than 10% blasts in bone marrow and no circulating blasts in peripheral blood for the following diagnoses:
No active CNS involvement by malignancy*
Availability of a donor who is a sibling, parent, or offspring who shares 1 full haplotype (HLA-A, -B, or -DR)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
No chronic active hepatitis B infection
No hepatitis C viral infection
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |||||
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting | ||||
| Bethesda, Maryland, United States, 20892-1182 | |||||
| Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |||||
| NCI - Center for Cancer Research-Medical Oncology |
| National Cancer Institute (NCI) |
| Study Chair: | Michael R. Bishop, MD | NCI - Center for Cancer Research-Medical Oncology |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Featured trial article 
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| Study ID Numbers: | CDR0000357432, NCI-04-C-0116 |
| First Received: | April 7, 2004 |
| Last Updated: | November 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00080925 |
| Health Authority: | Unspecified |
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