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

Purpose

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.

Condition	Intervention	Phase
Mantle Cell Lymphoma	Drug: Bortezomib Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Dexamethasone	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Dexamethasone Cyclophosphamide Dexamethasone acetate Vincristine sulfate Dexamethasone sodium phosphate Doxorubicin Doxorubicin hydrochloride Rituximab Bortezomib

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR). [ Time Frame: At completion of induction therapy (21 weeks) ] [ Designated as safety issue: No ]
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.
Complete Response Rate (CR) at the End of Induction Chemotherapy [ Time Frame: at 21 weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

3 Year Progression Free Survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
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.
3 Year Overall Survival (OS) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
This is the percent of participants who were still alive at 3 years after study entry.

Enrollment:	30
Study Start Date:	May 2005
Estimated Study Completion Date:	November 2013
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: VCR-CVAD with rituximab maintenance Induction chemotherapy with Bortezomib, cyclophosphamide, rituximab, vincristine, doxorubicin, and dexamethasone. Subjects will receive 6 cycles of induction chemotherapy, of 21 days each. After completing induction, subjects will receive rituximab consolidation (4 weeks), and then rituximab maintenance therapy for up to 5 years.	Drug: Bortezomib Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle. Other Name: Velcade, PS-341 Drug: 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). Other Name: Rituxan Drug: 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 Other Name: cytoxan Drug: 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. Drug: Vincristine 1 mg administered by IV on day 3 of each cycle. Drug: Dexamethasone 40 mg orally on days 1-4 of each cycle.

Arms

Assigned Interventions

Experimental: VCR-CVAD with rituximab maintenance

Induction chemotherapy with Bortezomib, cyclophosphamide, rituximab, vincristine, doxorubicin, and dexamethasone. Subjects will receive 6 cycles of induction chemotherapy, of 21 days each. After completing induction, subjects will receive rituximab consolidation (4 weeks), and then rituximab maintenance therapy for up to 5 years.

Drug: Bortezomib

Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle.

Other Name: Velcade, PS-341

Drug: 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).

Other Name: Rituxan

Drug: 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

Other Name: cytoxan

Drug: 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.

Drug: Vincristine

1 mg administered by IV on day 3 of each cycle.

Drug: Dexamethasone

40 mg orally on days 1-4 of each cycle.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581776

Locations

United States, Wisconsin
University Of Wisconsin Cancer Center
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Brad S Kahl, MD

University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00581776 History of Changes
Other Study ID Numbers:	HO05401
Study First Received:	December 19, 2007
Results First Received:	December 9, 2010
Last Updated:	April 23, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

Untreated Mantle Cell Lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Rituximab
Bortezomib
Dexamethasone
Doxorubicin
Vincristine

Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013