Bortezomib (Velcade) Plus Rituximab-HyperCVAD in Patients With Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00477412|
Recruitment Status : Active, not recruiting
First Posted : May 23, 2007
Last Update Posted : March 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma Lymphoma||Drug: Bortezomib Drug: Rituximab Drug: Cyclophosphamide Drug: Vincristine Drug: Methotrexate Drug: Cytarabine Drug: Doxorubicin||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 2007|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2021|
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.
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: RituxanDrug: Cyclophosphamide
1st Combination = 300 mg/m^2 IV Over 3 Hours Twice Daily Days 2,3,& 4.
Other Name: CytoxanDrug: 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 = 3g/m2 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
- Maximum Tolerated Dose (MTD) of Bortezomib Added to Combination of Rituximab, Methotrexate, and Cytarabine Alternating with Bortezomib, Rituximab-HyperCVAD [ Time Frame: Continual reassessment for toxicity with each 21 day cycle, up to 1 year ]MTD defined as highest dose of bortezomib in which 2 or fewer patients in 6 treated experiences a dose limiting toxicity (DLT) among dose levels tested. DLT defined as a grade 3-4 non-hematologic toxicity that can not be ameliorated, prevented, or controlled with standard prophylactic therapy such as, but not limited to, nausea, vomiting, fatigue, diarrhea, constipation, low electrolyte levels, or tumor pain.
- Median Time to Failure (TTF) [ Time Frame: Up to 10 years ]Failure defined as time from initiation of treatment to recurrence/progression of disease or death from either disease or toxicity. Participants will be followed for an additional 2 years after completion of the treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477412
|United States, New Jersey|
|Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Wang, MD, MS||M.D. Anderson Cancer Center|