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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00475384 |
Purpose
Primary Objectives:
To establish the feasibility of delayed infusion of ex vivo anergized donor peripheral blood mononuclear cells (PBMC) after CD34 selected megadose haploidentical hematopoietic stem cell transplant (HSCT)
Secondary Objectives:
To assess in vitro the function of immune cells engrafted in the recipient
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Myelodysplastic Syndrome Leukemia |
Drug: Fludarabine Drug: Thiotepa Radiation: Total Body Irradiation Drug: Melphalan Biological: Stem Cell Transplant (SCT) Procedure: Anergized Cell Infusion |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Delayed Infusion of Ex Vivo Anergized Peripheral Blood Mononuclear Cells Following CD34 Selected Peripheral Blood Stem Cell Transplant From A Haploidentical Donor For Patients With Acute Leukemia and Myelodysplasia |
| Estimated Enrollment: | 37 |
| Study Start Date: | June 2006 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Radiation+Chemotherapy+ Stem Cell Infusion
TBI (Total Body Irradiation) + Fludarabine + Thiotepa + SCT + Anergized cell infusion
|
Drug: Fludarabine
40 mg/m^2 By Vein Over 30 Minutes x 5 Days
Other Names:
Drug: Thiotepa
5 mg/kg By Vein Daily x 2 Days
Radiation: Total Body Irradiation
200 cGy (BID) Twice Daily Over 20-40 Minutes x 3 Days
Other Name: TBI
Biological: Stem Cell Transplant (SCT)
Infusion of normal donor stem cells on Day 0
Other Names:
Procedure: Anergized Cell Infusion
Infusion of stem cells treated with the anti-B7 antibodies on Day 35+ or 42+.
|
|
Experimental: Chemotherapy+Stem Cell Infusion
Melphalan + Thiotepa + Fludarabine + SCT + Anergized cell infusion
|
Drug: Fludarabine
40 mg/m^2 By Vein Over 30 Minutes x 5 Days
Other Names:
Drug: Thiotepa
5 mg/kg By Vein Daily x 2 Days
Drug: Melphalan
140 mg/m^2 by vein x 1 Day
Other Name: Alkeran
Biological: Stem Cell Transplant (SCT)
Infusion of normal donor stem cells on Day 0
Other Names:
Procedure: Anergized Cell Infusion
Infusion of stem cells treated with the anti-B7 antibodies on Day 35+ or 42+.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Childrens Hospital Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| United States, Florida | |
| University of Florida Shands Hospital | |
| Gainesville, Florida, United States, 32610-0278 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Eva Guinan, M.D | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00475384 History of Changes |
| Other Study ID Numbers: | 2005-0695, NCI |
| Study First Received: | May 16, 2007 |
| Last Updated: | October 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Myelodysplastic Syndrome Stem Cell Transplant Haploidentical Donor |
Leukemia Fludarabine Total Body Irradiation Thiotepa |
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bone Marrow Diseases Hematologic Diseases |
Precancerous Conditions Melphalan Thiotepa Fludarabine monophosphate Fludarabine Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |