Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma

Mantle Cell Lymphoma Clinical Trial

Official title:

Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581776
• Other study ID #: HO05401
• Secondary ID: 2011-0807A534260
• Status: Completed
• Phase: Phase 2
• Start date: May 2005
• Est. completion date: May 2015

Study information

• Verified date: May 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.

Description:

Primary objective is to estimate the overall response rate (ORR) and the complete response rate (CRR) to the VcR CVAD regimen (response rate at completion of induction). Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2015
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed CD20+ mantle cell lymphoma, with measurable or evaluable disease, no prior chemotherapy, immunotherapy or radiotherapy except for 1 cycle of CHOP-like chemotherapy.

Exclusion Criteria:

• Patients with known CNS disease, known HIV infection, grade 2 or greater peripheral neuropathy, history of myocardial infarction in last 6 months, or patients who are Hepatitis B Surface Antigen positive.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

Drug:
• Bortezomib
Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle.
• Rituximab
Administered by IV 375 mg/m2 IV day 1 of each cycle during induction chemotherapy, then weekly for four weeks during consolidation therapy; and then once every 12 weeks for up to 5 years (or until disease progression).
• Cyclophosphamide
Administered by IV at 300 mg/m2, 6 doses spaced 12 hours apart on days 1-3 of each cycle, to start after completion of rituximab infusion
• Doxorubicin
Given as a continuous infusion, 50 mg/m2 over 48 hours days 1-2 of each cycle, to start after completion of rituximab infusion.
• Vincristine
1 mg administered by IV on day 3 of each cycle.
• Dexamethasone
40 mg orally on days 1-4 of each cycle.

Locations

Country	Name	City	State
United States	University Of Wisconsin Cancer Center	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR).	Patients were considered evaluable for response if they completed at least 2 cycles of therapy and had undergone an initial response evaluation, or had disease progression after 1 cycle of therapy.; 1999 International Working Group criteria defines a CR as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. Partial Response indicates patients responded to treatment with a reduction in the amount of tumor (50 percent or more). Overall response rate is the percent of complete responses plus the percent of partial responses.	At completion of induction therapy (21 weeks)
Primary	Complete Response Rate (CR) at the End of Induction Chemotherapy	Complete Response Rate (CRR) as defined by 1999 International Working Group criteria, is defined as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. All subjects who had completed 2 cycles of therapy and had at least one disease evaluation, or had completed 1 cycle of therapy with progressive disease, were considered evaluable.	at 21 weeks
Secondary	3 Year Progression Free Survival	This is the percent of subjects who had not had any recurrence or relapse of disease as of 3 years after enrollment in the study.	36 months
Secondary	3 Year Overall Survival (OS)	This is the percent of participants who were still alive at 3 years after study entry.	36 months