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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: | NCT00477412 |
Purpose
The goal of this clinical research study is to learn if bortezomib (in combination with rituximab plus 2 different intensive chemotherapy regimens) can help to control the disease in patients with mantle cell lymphoma. The safety of these drug combinations will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Mantle Cell Lymphoma Lymphoma |
Drug: Bortezomib Drug: Rituximab Drug: Cyclophosphamide Drug: Vincristine Drug: Methotrexate Drug: Cytarabine Drug: Doxorubicin |
Phase I |
| 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: | Phase I Study of Bortezomib (Velcade) Plus Rituximab-HyperCVAD Alternating With Bortezomib Plus Rituximab-High Dose Methotrexate/Cytarabine in Patients With Untreated Aggressive Mantle Cell Lymphoma |
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2007 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bortezomib + Cyclophosphamide/Rituximab
1st Combination, Cycles 1,3,5 & 7 (if needed): Bortezomib + Rituximab + Cyclophosphamide + Doxorubicin + Vincristine; 2nd Combination, Cycles 2,4,6 & 8 (if needed): Rituximab + Methotrexate + Cytarabine.
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Drug: Bortezomib
1st Combination = 1.3 mg/m^2 IV Push Over 3-5 Seconds Days 2 & 5; 2nd Combination = 0.7 mg/m^2 IV Push Days 1 & 6.
Other Names:
Drug: Rituximab
375 mg/m^2 IV Over 6-8 Hours On Day 1 each cycle.
Other Name: Rituxan
Drug: Cyclophosphamide
1st Combination = 300 mg/m^2 IV Over 3 Hours Twice Daily Days 2,3,& 4.
Other Name: Cytoxan
Drug: Vincristine
1st Combination = 1.4 mg/m^2 (maximum 2 mg) IV Push Days 5 & 12.
Drug: Methotrexate
2nd Combination = 200 mg/m^2 IV over 2 hours on Day 1, then 800 mg/m^2 IV over 22 hours on Day 2.
Drug: Cytarabine
2nd Combination = .75 grams/m^2 IV over 2 Hours Twice a Day,On Days 3 & 4.
Other Names:
Drug: Doxorubicin
Arm 1: 50 mg/m^2 IV Push Over 15-30 min on Day 5
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jorge Romaguera, MD | 713-792-2860 |
| United States, New Jersey | |
| Hackensack University Medical Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Jorge Romaguera, MD | |
| Principal Investigator: | Jorge Romaguera, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00477412 History of Changes |
| Other Study ID Numbers: | 2006-0697 |
| Study First Received: | May 21, 2007 |
| Last Updated: | December 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Mantle Cell Lymphoma Lymphoma Bortezomib LDP-341 MLN341 Velcade Cyclophosphamide Neosar Cytoxan Doxorubicin Adriamycin |
Rubex Rituximab Vincristine Methotrexate Cytarabine Cytosar DepoCyt Cytosine arabinosine hydrochloride Mesna Dexamethasone |
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Cyclophosphamide Cytarabine Methotrexate Rituximab Bortezomib Doxorubicin |
Vincristine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents |