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| Sponsor: | 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 |
Biological: therapeutic allogeneic lymphocytes Drug: sirolimus |
Phase II |
| 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: | 230 |
| Study Start Date: | December 2003 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group 1 (allogeneic transplantation): Experimental
Patients receive donor 12-day cultured Th2 cells IV on day 1.
|
Biological: therapeutic allogeneic lymphocytes
Given IV
|
|
Group 2 (allogeneic transplantation): Experimental
Patients receive donor 12-day cultured 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.
|
Biological: therapeutic allogeneic lymphocytes
Given IV
Drug: sirolimus
Given orally
|
|
Group 3 (allogeneic transplantation): Experimental
Patients receive oral sirolimus as in group 2.
|
Drug: sirolimus
Given orally
|
|
Group 4 (allogeneic transplantation): Experimental
Patients receive donor 12-day or 6-day cultured Th2 cells and sirolimus as in group 2.
|
Biological: therapeutic allogeneic lymphocytes
Given IV
Drug: sirolimus
Given orally
|
|
Group 5 (allogeneic transplantation): Experimental
Patients receive donor 12-day cultured Th2 cells IV on day 0. Patients also receive sirolimus as in group 2.
|
Biological: therapeutic allogeneic lymphocytes
Given IV
Drug: sirolimus
Given orally
|
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)
High-risk lymphoma including, but not limited to, plasma dendritic cell type, hepato-splenic T cell type, gamma delta pinniculitic T cell type, muco-cutaneous NK cell type, or stage III-IV nasal NK cell type
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
LVEF ≥ 45% by 2-dimensional ECHO or MUGA
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Surgery
Other
Contacts and Locations| United States, Maryland | |
| NCI - Center for Cancer Research | 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 | |
| Study Chair: | Daniel Fowler, MD | National Cancer Institute (NCI) |
More Information
| Responsible Party: | NCI - Center for Cancer Research ( Daniel Fowler ) |
| Study ID Numbers: | CDR0000350350, NCI-04-C-0055 |
| Study First Received: | February 10, 2004 |
| Last Updated: | October 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00077480 History of Changes |
| Health Authority: | Unspecified |
|
graft versus host disease refractory chronic lymphocytic leukemia accelerated phase chronic myelogenous leukemia chronic phase chronic myelogenous leukemia refractory anemia with excess blasts in transformation refractory anemia with excess blasts relapsing chronic myelogenous leukemia recurrent adult Hodgkin lymphoma refractory multiple myeloma chronic idiopathic myelofibrosis recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult immunoblastic large cell lymphoma |
recurrent mantle cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult lymphoblastic lymphoma secondary myelodysplastic syndromes adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission de novo myelodysplastic syndromes previously treated myelodysplastic syndromes chronic myelomonocytic leukemia polycythemia vera essential thrombocythemia myelodysplastic/myeloproliferative disease, unclassifiable recurrent marginal zone lymphoma |
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Sirolimus Anti-Infective Agents Immunologic Factors Precancerous Conditions Hematologic Neoplasms Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Antibiotics, Antineoplastic Hemostatic Disorders Anti-Bacterial Agents Leukemia Preleukemia Neoplasms by Site |
Pathologic Processes Hemorrhagic Disorders Antifungal Agents Therapeutic Uses Syndrome Cardiovascular Diseases Lymphoma Disease Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Vascular Diseases |