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

NCT ID: NCT00581776

Last Updated: 2019-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mantle Cell Lymphoma

Keywords

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Untreated Mantle Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Bortezomib

Intervention Type DRUG

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

Rituximab

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

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

Interventions

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Bortezomib

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

Intervention Type 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).

Intervention Type 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

Intervention Type 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.

Intervention Type DRUG

Vincristine

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

Intervention Type DRUG

Dexamethasone

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

Intervention Type DRUG

Other Intervention Names

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Velcade, PS-341 Rituxan cytoxan

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brad S Kahl, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University Of Wisconsin Cancer Center

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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2011-0807

Identifier Type: OTHER

Identifier Source: secondary_id

A534260

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\MEDICINE\HEM-ONC

Identifier Type: OTHER

Identifier Source: secondary_id

HO05401

Identifier Type: -

Identifier Source: org_study_id