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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: | NCT00077480 |
Purpose
RATIONALE: Sirolimus may be effective in preventing graft-versus-host disease in patients who are undergoing allogeneic stem cell transplantation.
PURPOSE: This phase II trial is studying four different regimens of sirolimus-treated T cells and/or sirolimus by mouth and comparing how well they work in preventing graft-versus-host disease in patients who are undergoing allogeneic hematopoietic stem cell transplantation for hematologic malignancies .
| Condition | Intervention | Phase |
|
Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: sirolimus Drug: therapeutic allogeneic lymphocytes |
Phase II |
| Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma |
| Drug Information available for: | Sirolimus |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Active Control |
| Official Title: | Pilot Study Of Sirolimus (Rapamycin) Generated Donor Th2 Cells And In Vivo Sirolimus For GVHD Prevention After Allogeneic HSCT For Hematologic Malignancy |
| Estimated Enrollment: | 190 |
| Study Start Date: | December 2003 |
| Arms | Assigned Interventions |
|
Group 1 (allogeneic transplantation): Experimental
Patients receive donor Th2 cells IV on day 1.
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Drug: therapeutic allogeneic lymphocytes
Given IV
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Group 2 (allogeneic transplantation): Experimental
Patients receive donor Th2 cells IV on day 14. Patients also receive an initial loading dose of oral sirolimus once on day -2 and then oral sirolimus once daily on days -1 to 14.
|
Drug: sirolimus
Given orally
Drug: therapeutic allogeneic lymphocytes
Given IV
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Group 3 (allogeneic transplantation): Experimental
Patients receive oral sirolimus as in group 2.
|
Drug: sirolimus
Given orally
|
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Group 4 (allogeneic transplantation): Experimental
Patients receive donor Th2 cells and sirolimus as in group 2.
|
Drug: sirolimus
Given orally
Drug: therapeutic allogeneic lymphocytes
Given IV
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Group 5 (allogeneic transplantation): Experimental
Patients receive donor Th2 cells IV on day 0. Patients also receive sirolimus as in group 2.
|
Drug: sirolimus
Given orally
Drug: therapeutic allogeneic lymphocytes
Given IV
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histological diagnosis of 1 of the following hematologic malignancies, myelodysplasia, or myeloproliferative disorders:
Chronic lymphocytic leukemia
Hodgkin's or non-Hodgkin's lymphoma (all types, including mantle cell lymphoma)
Multiple myeloma
Acute myeloid leukemia
Acute lymphoblastic leukemia
Myelodysplastic syndromes
Myeloproliferative disorders*
Chronic myelogenous leukemia
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Surgery
Other
Contacts and Locations| United States, Maryland | |||||
| NCI - Center for Cancer Research-Medical Oncology | Recruiting | ||||
| Bethesda, Maryland, United States, 20892 | |||||
| Contact: Clinical Trials Office - NCI - Center for Cancer Research 888-624-1937 | |||||
| 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 | |||||
| United States, New Jersey | |||||
| Hackensack University Medical Center Cancer Center | Recruiting | ||||
| Hackensack, New Jersey, United States, 07601 | |||||
| Contact: Clinical Trials Office - Hackensack University Medical Center 201-996-2879 | |||||
| NCI - Center for Cancer Research-Medical Oncology |
| National Cancer Institute (NCI) |
| Study Chair: | Daniel Fowler, 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: | CDR0000350350, NCI-04-C-0055 |
| First Received: | February 10, 2004 |
| Last Updated: | November 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00077480 |
| Health Authority: | Unspecified |
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