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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Cephalon |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00880815 |
Primary Objective:
To determine engraftment and dose limiting toxicity (DLT) of Bendamustine in patients with lymphoid malignancies undergoing non-myeloablative allogeneic hematopoietic transplantation.
Secondary Objective:
To monitor the risk of graft-versus-host disease (GVHD) and clinical responses.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Drug: Bendamustine Drug: Rituximab Drug: Fludarabine Procedure: Stem Cell Transplant (SCT) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Fludarabine, Bendamustine and Rituximab (FBR) Non-Myeloablative Allogeneic Conditioning for Patients With Lymphoid Malignancies |
Estimated Enrollment: | 46 |
Study Start Date: | April 2009 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Bendamustine + Chemotherapy + SCT: Experimental |
Drug: Bendamustine
Starting dose of 70 mg/m^2 by vein over 1 hour on Day -5 through Day -3.
Drug: Rituximab
Dose of 375 mg/m^2 by vein over 5-7 hours on Day -13 and 1000 mg/m^2 on Day -6, Day +1 and Day +8 (1 time each week for four weeks).
Drug: Fludarabine
30 mg/m^2 on Day -5 to Day -3.
Procedure: Stem Cell Transplant (SCT)
Infusion of donor blood stem cells by vein over 30-45 minutes on Day 0.
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Issa F. Khouri, MD, BS | 713-792-8750 |
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Issa F. Khouri, MD, BS |
Principal Investigator: | Issa F. Khouri, MD, BS | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Issa F. Khouri, MD, BS / Professor ) |
Study ID Numbers: | 2008-0246 |
Study First Received: | April 13, 2009 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00880815 History of Changes |
Health Authority: | United States: Institutional Review Board |
Leukemia Lymphoma Lymphoid Malignancies Non-myeloablative Allogeneic Conditioning Non-myeloablative Allogeneic Hematopoietic Transplantation Stem Cell Transplant SCT Bendamustine HCI Bendamustine Bendamustine Hydrochloride CEP-18083 |
SDX-105 Treanda Fludarabine Fludarabine Phosphate Fludara Rituximab Rituxan FBR Graft-versus-host disease GVHD |
Antimetabolites Immunoproliferative Disorders Immunologic Factors Rituximab Fludarabine monophosphate Immunosuppressive Agents Homologous Wasting Disease Graft Versus Host Disease Leukemia Lymphatic Diseases |
Mechlorethamine Graft vs Host Disease Antineoplastic Agents, Alkylating Fludarabine Antirheumatic Agents Lymphoproliferative Disorders Alkylating Agents Lymphoma Nitrogen Mustard Compounds Bendamustine |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leukemia Therapeutic Uses Lymphoma Alkylating Agents Bendamustine Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Rituximab Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Fludarabine Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Antirheumatic Agents Nitrogen Mustard Compounds |