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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Millennium Pharmaceuticals, Inc. |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00439556 |
Purpose
The goal of this clinical research study is to find the highest tolerable dose of Velcade (bortezomib) that can be given with BEAM (carmustine, etoposide, cytarabine and melphalan) and rituximab in patients with lymphoma who receive a stem cell transplant.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: Carmustine Drug: Cytarabine Drug: Etoposide Drug: Melphalan Drug: Rituximab Drug: Bortezomib Other: Allogeneic Stem Cell Infusion |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Bortezomib (Velcade) and Reduced-Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoid Malignancies |
| Estimated Enrollment: | 52 |
| Study Start Date: | February 2007 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bortezomib + Reduced Intensity Allo SCT
Bortezomib + BEAM (Carmustine, Etoposide, Cytarabine and Melphalan) + Rituximab Allo SCT = Allogeneic Stem Cell Transplantation |
Drug: Carmustine
300 mg/m^2 IV on Day -6
Other Names:
Drug: Cytarabine
100 mg/m^2 IV twice a day x 4 Days (Days -5 through -2)
Other Names:
Drug: Etoposide
100 mg/m^2 IV twice a day x 4 Days (Days -5 through -2)
Other Name: VePesid
Drug: Melphalan
100 mg/m^2 IV on Day -1
Drug: Rituximab
375 mg/m^2 IV on Day -13; 1000 mg/m^2 on Days -6, 1, & 8.
Other Name: Rituxan
Drug: Bortezomib
1.3 mg/m^2 IV on Days -13, -6, -1 and +2.
Other Names:
Other: Allogeneic Stem Cell Infusion
Allogeneic Stem Cell Infusion administered on Day 0.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Issa F. Khouri, MD | 713-792-8750 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Issa F. Khouri, MD | |
| Principal Investigator: | Issa F. Khouri, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00439556 History of Changes |
| Other Study ID Numbers: | 2006-0066 |
| Study First Received: | February 22, 2007 |
| Last Updated: | March 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Lymphoma Bortezomib Velcade LDP-341 MLN341 PS-341 Carmustine Cytarabine Etoposide Melphalan |
Rituximab BEAM BCNU BiCNU® ARA-C Cytosar DepoCyt® Cytosine arabinosine hydrochloride VePesid® Rituxan |
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Carmustine Melphalan Etoposide phosphate Rituximab Bortezomib Cytarabine Etoposide Antineoplastic Agents, Alkylating |
Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Myeloablative Agonists Antirheumatic Agents |