A Phase I/II Trial of VR-CHOP in Lymphoma Patients
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|ClinicalTrials.gov Identifier: NCT00634179|
Recruitment Status : Completed
First Posted : March 12, 2008
Results First Posted : March 15, 2016
Last Update Posted : October 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, B-Cell Follicular Lymphoma||Drug: Bortezomib Biological: Rituximab Drug: Doxorubicin Drug: Cyclophosphamide Drug: Vincristine Drug: Prednisone||Phase 1 Phase 2|
This study will assess whether adding bortezomib (Velcade) to R-CHOP (in a new combination called VR-CHOP) can further improve outcomes in patients with indolent NHL who have not previously received treatment.
Patients who are eligible to take part in the study will receive VR-CHOP at the doses of Velcade and vincristine established in phase 1. Patients will receive VR-CHOP for up to 8 cycles of treatment (each of 21 days duration). During treatment, patients will be assessed for their response to therapy and for possible side effects. All patients will go on to receive maintenance therapy after completion of their initial treatment as designed by the protocol.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of VR-CHOP for Patients With Untreated Follicular Lymphoma and Other Low Grade B-Cell Lymphomas|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Experimental: Treatment (VR-CHOP regimen)
INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.
MAINTENANCE: Patients achieving complete response (CR) receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity.
Bortezomib 1.6 mg/m² given on days 1 and 8
Other Name: VelcadeBiological: Rituximab
Rituximab 375 mg/m²
Other Names:Drug: Doxorubicin
Doxorubicin 50 mg/m²
Other Name: AdriamycinDrug: Cyclophosphamide
Cyclophosphamide 750 mg/m²
Other Name: NeosarDrug: Vincristine
Vincristine 1.4 mg/m² (capped at 1.5 mg maximum) given on day 1
Other Name: OncovinDrug: Prednisone
Prednisone 100 mg/day given orally on days 1-5
Other Name: Deltasone
- Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I) [ Time Frame: Cycle 1 for MTD, following completion of therapy for CR, up to 24 weeks ]INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.
- An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria [ Time Frame: Following completion of therapy, up to 2 years ]Response was assessed by computerized tomography (CT) after every 2 cycles of induction therapy, one time at least 4 weeks after completing induction (i.e., prior to maintenance), and then every 3 months while on maintenance therapy. At the conclusion of maintenance therapy, patients underwent one post-treatment scan, with further scans completed at the discretion of the treating physician. Positron emission tomography was permitted but only CT measurements were used to determine response.
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): NCT00634179
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Christopher Flowers, MD||Emory University|