Phase 2 Hyper-CVAD/Rituximab for Untreated Mantle Cell Lymphoma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2010-03-31

Brief Summary

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rituximab and modified (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years

Detailed Description

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rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years

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

Interventions

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modified Hyper-CVAD

rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Untreated mantle cell lymphoma

Exclusion Criteria

* Pregnant or breast feeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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UWCCC

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Kahl BS, Longo WL, Eickhoff JC, Zehnder J, Jones C, Blank J, McFarland T, Bottner W, Rezazedeh H, Werndli J, Bailey HH; Wisconsin Oncology Network. Maintenance rituximab following induction chemoimmunotherapy may prolong progression-free survival in mantle cell lymphoma: a pilot study from the Wisconsin Oncology Network. Ann Oncol. 2006 Sep;17(9):1418-23. doi: 10.1093/annonc/mdl127. Epub 2006 Jun 9.

Reference Type RESULT

PMID: 16766582 (View on PubMed)

Other Identifiers

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HO00401

Identifier Type: -

Identifier Source: org_study_id