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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00427557 |
Purpose
The goal of this clinical research study is to learn if giving umbilical cord blood along with standard stem cells after high-dose chemotherapy will improve the response to a stem cell transplant. The safety of this treatment will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma Leukemia Lymphoma |
Drug: Fludarabine Drug: Melphalan Procedure: Umbilical Cord Blood Drug: Rituximab Other: Peripheral Blood Stem Cell Infusion |
Phase II |
| 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: | Use of Umbilical Cord Blood Cell in the Preparative Regimen of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Stem Cell Transplantation |
| Enrollment: | 31 |
| Study Start Date: | October 2006 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Fludarabine + Melphalan + Rituximab + Cord Blood Transplantation + Stem Cell Transplantation
|
Drug: Fludarabine
30 mg/m^2 by vein x 4 Days (Day -10 through Day -7).
Other Names:
Drug: Melphalan
140 mg/m^2 by vein x 1 Day (Day -7).
Procedure: Umbilical Cord Blood
1 UCB Unit by vein on Day -5.
Other Name: UCB
Drug: Rituximab
375 mg/m^2 by vein once weekly (Days -7, -1, +7, +14)x 4 Weeks (if appropriate).
Other Name: Rituxan
Other: Peripheral Blood Stem Cell Infusion
Infusion of blood stem cells on Day 0.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Partow Kebriaei, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Partow Kebriaei, MD/Asst. Professor, U.T. M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00427557 History of Changes |
| Other Study ID Numbers: | 2006-0553 |
| Study First Received: | January 25, 2007 |
| Last Updated: | December 29, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Multiple Myeloma Acute Myeloid Leukemia Myelodysplastic Syndrome Acute Lymphoblastic Leukemia Non-Hodgkin's Lymphoma Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Cellular Therapy Umbilical Cord Blood Cells Cord Blood Transplantation Stem Cells Stem Cell Transplantation |
Allogeneic Hematopoietic Stem Cell Transplantation Graft vs. Host Disease GVD Fludarabine Fludarabine Phosphate Fludara Melphalan Rituximab Rituxan Leukemia Lymphoma |
|
Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders |
Hematologic Diseases Hemorrhagic Disorders Melphalan Fludarabine monophosphate Fludarabine Rituximab Vidarabine Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Alkylating |