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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Cephalon |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00880815 |
Purpose
The goal of this clinical research study is to learn if bendamustine, when given with a stem cell transplant and chemotherapy (fludarabine and rituximab), can help the transplanted stem cells start to grow and make new blood cells in patients with leukemia and lymphoma. The safety of this combination will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Drug: Bendamustine Drug: Rituximab Drug: Fludarabine Procedure: Stem Cell Transplant (SCT) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Fludarabine, Bendamustine and Rituximab (FBR) Non-myeloablative Allogeneic Conditioning for Patients With Lymphoid Malignancies |
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bendamustine + Chemotherapy + SCT |
Drug: Bendamustine
Starting dose of 70 mg/m^2 by vein over 1 hour on Day -5 through Day -3.
Other Names:
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).
Other Name: Rituxan
Drug: Fludarabine
30 mg/m^2 on Day -5 to Day -3.
Other Names:
Procedure: Stem Cell Transplant (SCT)
Infusion of donor blood stem cells by vein over 30-45 minutes on Day 0.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00880815 History of Changes |
| Other Study ID Numbers: | 2008-0246 |
| Study First Received: | April 13, 2009 |
| Last Updated: | November 7, 2011 |
| 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 |
|
Neoplasms Leukemia Lymphoma Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bendamustine Fludarabine monophosphate Fludarabine Rituximab Nitrogen Mustard Compounds Vidarabine |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Antirheumatic Agents |