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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00591630 |
Purpose
The goal of this clinical research study is to learn if the addition of 90Y Zevalin to BEAM chemotherapy (carmustine, etoposide, cytarabine, and melphalan) and rituximab is more effective than the combination of BEAM and rituximab alone in patients with lymphoma who receive a stem cell transplant.
| Condition | Intervention | Phase |
|---|---|---|
|
Diffuse Large Cell Lymphoma Lymphoma |
Drug: Zevalin Drug: Carmustine Drug: Etoposide Drug: Cytarabine Drug: Melphalan Drug: Rituximab Procedure: Stem Cell Transplant |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Zevalin/BEAM/Rituximab vs BEAM/Rituximab With or Without Rituximab Maintenance in Autologous Stem Cell Transplantation for Diffuse Large B-Cell Lymphomas |
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2007 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
|
Drug: Zevalin
(111In Zevalin) 5 mCi by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
Other Names:
Drug: Carmustine
300 mg/m^2 by vein.
Other Names:
Drug: Etoposide
200 mg/m^2 by vein every 12 hours.
Other Name: VePesid
Drug: Cytarabine
200 mg/m^2 by vein every 12 hours.
Other Names:
Drug: Melphalan
140 mg/m^2 by vein.
Drug: Rituximab
Arm 1, Arm 2 = 250 mg/m^2 by vein; Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant; Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy. Other Name: Rituxan
Procedure: Stem Cell Transplant
Injection of stem cells (Autologous SCT)
Other Names:
|
|
Active Comparator: 2
Zevalin + BEAM + Rituximab Followed by Stem Cell Transplant
|
Drug: Zevalin
(111In Zevalin) 5 mCi by vein and (90Y Zevalin) 0.4 mCI/kg by vein.
Other Names:
Drug: Carmustine
300 mg/m^2 by vein.
Other Names:
Drug: Etoposide
200 mg/m^2 by vein every 12 hours.
Other Name: VePesid
Drug: Cytarabine
200 mg/m^2 by vein every 12 hours.
Other Names:
Drug: Melphalan
140 mg/m^2 by vein.
Drug: Rituximab
Arm 1, Arm 2 = 250 mg/m^2 by vein; Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant; Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy. Other Name: Rituxan
Procedure: Stem Cell Transplant
Injection of stem cells (Autologous SCT)
Other Names:
|
|
Active Comparator: 3
BEAM + Rituximab Followed by Stem Cell Transplant and Maintenance Rituximab
|
Drug: Carmustine
300 mg/m^2 by vein.
Other Names:
Drug: Etoposide
200 mg/m^2 by vein every 12 hours.
Other Name: VePesid
Drug: Cytarabine
200 mg/m^2 by vein every 12 hours.
Other Names:
Drug: Melphalan
140 mg/m^2 by vein.
Drug: Rituximab
Arm 1, Arm 2 = 250 mg/m^2 by vein; Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant; Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy. Other Name: Rituxan
Procedure: Stem Cell Transplant
Injection of stem cells (Autologous SCT)
Other Names:
|
|
Active Comparator: 4
BEAM + Rituximab Followed by Stem Cell Transplant
|
Drug: Carmustine
300 mg/m^2 by vein.
Other Names:
Drug: Etoposide
200 mg/m^2 by vein every 12 hours.
Other Name: VePesid
Drug: Cytarabine
200 mg/m^2 by vein every 12 hours.
Other Names:
Drug: Melphalan
140 mg/m^2 by vein.
Drug: Rituximab
Arm 1, Arm 2 = 250 mg/m^2 by vein; Arm 1, Arm 2, Arm 3, Arm 4 = 1000 mg/m^2 by vein following Stem Cell Transplant; Arm 1, Arm 3 = 375 mg/m² by vein Maintenance Therapy. Other Name: Rituxan
Procedure: Stem Cell Transplant
Injection of stem cells (Autologous SCT)
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| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Issa F. Khouri, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00591630 History of Changes |
| Other Study ID Numbers: | 2006-1018 |
| Study First Received: | December 27, 2007 |
| Last Updated: | February 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Diffuse Large Cell Lymphoma Lymphoma Zevalin Ibritumomab IDEC-Y2B8 Carmustine BCNU BiCNU Etoposide VePesid |
Cytarabine Ara-C Cytosar DepoCyt Cytosine arabinosine hydrochloride Melphalan Rituximab Rituxan BEAM |
|
Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Carmustine Melphalan Etoposide phosphate Rituximab 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 |