Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00401817|
Recruitment Status : Completed
First Posted : November 22, 2006
Results First Posted : October 20, 2017
Last Update Posted : October 20, 2017
1. To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL).
- To evaluate the response rate and time to disease progression of the RA-CHOP regimen in patients with newly diagnosed MCL.
- To prospectively characterize the angiogenic profiles of MCL patients during RA-CHOP treatment.
|Condition or disease||Intervention/treatment||Phase|
|Untreated Mantle Cell Lymphoma||Drug: Bevacizumab Drug: Rituximab Drug: CHOP||Phase 2|
Bevacizumab administered at 15 mg/kg on day 1 of each of 6 cycles
Rituximab administered 375 mg/m2 on day 3 of each of 6 cycles (with usual premedications)
Standard CHOP chemotherapy administered on day 3 every 21 days (full dose) for 6 cycles of treatment
Once completed six cycles of therapy (~18 weeks), patients will be evaluated every 3 months for the first year post treatment, then every 6 months until disease progression or death for years 2 through 5 post treatment. Patients who have disease progression will be contacted every 6 months until death to assess for survival status.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Bevacizumab Plus CHOP-Rituximab in Patients With Untreated Mantle Cell Lymphoma (NHL)|
|Actual Study Start Date :||November 2007|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||November 2013|
Experimental: Study Treatment Arm
Bevacizumab-R-CHOP therapy included bevacizumab administered at 15 mg/kg on day 1, and standard dose R-CHOP on day 3, for six 21-day cycles
15 mg/kg on day 1 of each of 6 cyclesDrug: Rituximab
Rituximab will be administered prior to CHOP on day 3 of every cycle for a total of 6 cycles.
The dose to be administered is:
Rituximab: 375 mg/m2
Standard CHOP chemotherapy will be administered at full dose every 21 days for a total of 6 cycles. The doses to be used are: Cyclophosphamide: 750 mg/m2 IV on day 3 Doxorubicin: 50 mg/m2 IV on day 3 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 3 Prednisone: 100 mg PO days 3 - 7
- Number of Participants With Toxicity [ Time Frame: 38 months ]Number of patients with reversible myelosuppression (Primary toxicity was reversible myelosuppression) Toxicities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.
- Overall Response Rate [ Time Frame: 38 Months (min 33 months, max 62 months) ]
Overall Response Rate measured using Kaplan-Meier survival analysis
Response criteria were those reported by Cheson et al. (1999)
- Progression-Free Survival [ Time Frame: 3 years ]
The percentage of patients who have not progressed at the three year time point.
The 3-year PFS rate was estimated based on the Kaplan-Meier analysis.
- Overall Survival [ Time Frame: 3 years ]
The percentage of patients who have survived at the three year time point.
The 3-year OS rate was estimated based on the Kaplan-Meier analysis.
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): NCT00401817
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, New York|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10021|
|Principal Investigator:||John P Leonard, MD||Weill Medical College of Cornell University|