Bevacizumab + CHOP-Rituximab in Untreated Mantle Cell Lymphoma

Conditions

• Untreated Mantle Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — DRUG
  15 mg/kg on day 1 of each of 6 cycles
• Rituximab — DRUG
  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
• CHOP — DRUG
  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

Study Details

Primary Objective 1\. To evaluate the safety profile of Bevacizumab (Bevacizumab™)- Rituximab (Rituxan®)-CHOP (RA-CHOP) in patients with newly diagnosed mantle cell lymphoma (MCL). Secondary Objectives 1. To evaluate the response rate and time to disease progression of the RA-CHOP regimen in patients with newly diagnosed MCL. 2. To prospectively characterize the angiogenic profiles of MCL patients during RA-CHOP treatment.

Key Dates

Start date

Nov 30, 2007

Status verified

Sep 2017

Primary completion

Jul 31, 2011

Completion

Nov 30, 2013

Study Design

Enrollment

11 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Number of Participants With Toxicity [ Time Frame: 38 months ]

Locations (2)

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