|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00066300 |
Purpose
RATIONALE: Peripheral stem cell transplantation may be able to replace 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 may prevent this from happening. Infusions of donor lymphocytes may decrease the body's rejection of the transplanted peripheral stem cells.
PURPOSE: Phase II trial to study the effectiveness of allogeneic stem cell transplantation followed by donor lymphocyte infusions in treating patients who have hematologic cancer.
| Condition | Intervention | Phase |
|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: therapeutic allogeneic lymphocytes Procedure: allogeneic bone marrow transplantation Procedure: graft-versus-tumor induction therapy Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase II |
| MedlinePlus related topics: | Anemia Bone Marrow Transplantation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma |
| Drug Information available for: | Cyclophosphamide Fludarabine Fludarabine monophosphate Cyclosporine Cyclosporin |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation Followed By T Cell Add-Back For Hematological Malignancies - Effect Of Irradiated Donor Lymphocytes On Chimerism |
| Study Start Date: | May 2003 |
OBJECTIVES:
OUTLINE:
Patients are followed at 3, 6, and 12 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 10 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of any of the following hematologic malignancies:
Chronic myelogenous leukemia (CML) in chronic phase meeting 1 of the following criteria:
Acute lymphoblastic leukemia meeting any of the following criteria:
Acute myeloid leukemia meeting any of the following criteria:
Myelodysplastic syndromes of any of the following types:
Myeloproliferative disorders in transformation to acute leukemia, of any of the following types:
Chronic lymphocytic leukemia that is refractory to fludarabine with 1 of the following:
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 | |||||
| Warren Grant Magnuson Clinical Center | |||||
| Bethesda, Maryland, United States, 20892-1182 | |||||
| Study Chair: | Austin J. Barrett, MD, FRCP | NHLBI - Bone Marrow Transplantation Unit |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000315460, NHLBI-03-H-0192 |
| First Received: | August 6, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00066300 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|
|