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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center Otsuka Pharmaceutical Co., Ltd. National Institutes of Health (NIH) |
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Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00796562 |
The purpose of this study is to see if giving high dose chemotherapy and total body irradiation before and repeating high dose chemotherapy after a bone marrow transplant could reduce the incidence of graft rejection and disease for patients with blood cancers
Condition | Intervention | Phase |
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MDS Leukemias Lymphomas |
Drug: Drug: busulfan, Cyclophosphamide, Total Body Irradiation |
Phase II |
Study Type: | Interventional |
Study Design: | Screening, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | A Phase II Trial of Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Bone Marrow for Patients With Hematologic Malignancies |
Estimated Enrollment: | 20 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Active Comparator
All patients except those with acute lymphoblastic leukemias and lymphoblastic lymphomas
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Drug: Drug: busulfan, Cyclophosphamide, Total Body Irradiation
Arm A: Patient will receive Busulfan injections, 4 times a day for 4 days with dilantin prophylaxis(in patients 10 years of age or older). Busulfan levels in the blood will be measured and dose adjusted, if needed. Patient will then receive Cy by IV once a day for 2 days. Arm B: Patients will start on Cy IV once a day for 2 days followed by TBI once a day for 4 days. Transplant: Bone Marrow Transplant will follow busulfan/Cy or Cy/TBI preparative regimen. |
Arm B: Active Comparator
Patients with acute lymphocytic leukemia or lymphoblastic lymphoma
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Drug: Drug: busulfan, Cyclophosphamide, Total Body Irradiation
Arm A: Patient will receive Busulfan injections, 4 times a day for 4 days with dilantin prophylaxis(in patients 10 years of age or older). Busulfan levels in the blood will be measured and dose adjusted, if needed. Patient will then receive Cy by IV once a day for 2 days. Arm B: Patients will start on Cy IV once a day for 2 days followed by TBI once a day for 4 days. Transplant: Bone Marrow Transplant will follow busulfan/Cy or Cy/TBI preparative regimen. |
Allogeneic blood or marrow transplantation (alloBMT), following either marrow-ablative or nonmyeloablative conditioning, is a potentially curative treatment for a variety of hematologic malignancies and non-malignant hematologic disorders. Of all the potential sources of allografts, transplantation of stem cells from a human leukocyte antigen (HLA)-matched sibling has generally produced the best overall outcomes, i.e. overall and progression-free survival. Unfortunately, only about a third of candidates for alloBMT have HLA-matched siblings.
For patients who lack HLA-matched siblings, there are three alternative sources of stem cells for alloBMT: 1) volunteer unrelated donors; 2) umbilical cord blood; and 3) partially HLA-mismatched, or haploidentical, related donors. Since any patient shares exactly one HLA haplotype with each biological parent or child and half of siblings, an eligible haploidentical donor can be identified rapidly in nearly all cases. However, haploidentical BMT has been associated with significant risks of graft rejection and severe GVHD, which are manifestations of excessive alloreactivity by host and donor T cells, respectively.
The risk of severe GVHD may be reduced in intensively conditioned recipients of grafts that have been rigorously depleted of mature T cells or selectively depleted of alloreactive T cells, but the risks of serious infection and death from prolonged immune compromise in these patients remains high. Cyclophosphamide(Cy) is a highly immunosuppressive antineoplastic agent that has an established role in conditioning for alloBMT.
Typically, the drug is administered prior to transplantation to prevent graft rejection by suppressing the host immune system. However, pre-transplantation conditioning with Cy increases the risk of GVHD following allogeneic T cell infusion in mouse models. In contrast, administration of a properly timed, high dose of Cy after BMT inhibits both graft rejection and GVHD.
Ages Eligible for Study: | 6 Months to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Heather Symons, M.D. | 410-502-9961 | hsymons2@jhmi.edu |
United States, Maryland | |
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting |
Baltimore, Maryland, United States, 21231 | |
Contact: Heather Symons, M.D. hsymons2@jhmi.edu | |
Principal Investigator: Heather Symons, M.D. | |
Sidney Kimmel Comprehensive Cancer Center | Recruiting |
Baltimore, Maryland, United States, 21231 | |
Contact: Heather Symons, MD 410-502-9961 hsymons2@jhm.edu |
Principal Investigator: | Heather Symons, M.D. | Johns Hopkins University |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center ( Heather Symons, M.D. ) |
Study ID Numbers: | J0820, JHH IRB# NA_00015795 |
Study First Received: | November 20, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00796562 |
Health Authority: | United States: Institutional Review Board |
Leukemia Lymphoma Hematologic malignancies ALL AML MDS Transplantation Mismatched Haploidentical |
Busulfan Cyclophosphamide Cellcept Tacrolimus TBI CMMOL CML JMML |
Phenytoin Lymphatic Diseases Leukemia Immunoproliferative Disorders Hematologic Neoplasms Hematologic Diseases |
Busulfan Mycophenolate mofetil Tacrolimus Cyclophosphamide Lymphoproliferative Disorders Lymphoma |
Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |