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Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Weill Medical College of Cornell University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00151320
First received: September 6, 2005
Last updated: July 27, 2010
Last verified: July 2010
  Purpose

Primary Objective:

To determine the toxicity profile and maximum tolerated dose (MTD) of VELCADE when administered in combination with CHOP + Rituximab to patients with previously untreated diffuse large B cell or mantle cell non-Hodgkin's lymphoma (NHL)

Secondary Objectives:

To assess the response rate (overall and complete), event-free survival and overall survival with VELCADE and CHOP-R in patients with previously untreated diffuse large B cell or mantle cell lymphoma (phase II component)

Treatment:

Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles

Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:

Level Dose/Schedule (-2) 0.7 mg/m2 on day 1 of each cycle (-1) 0.7 mg/m2 on days 1 and 8 (0) 0.7 mg/m2 on days 1 and 4 (+1) 1.0 mg/m2 on days 1 and 4 (+2) 1.3 mg/m2 on days 1 and 4


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Bortezomib, CHOP, Rituximab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Trial of VELCADE+ CHOP-Rituximab in Patients With Previously Untreated Diffuse Large B Cell or Mantle Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • determine maximum tolerated dose [ Time Frame: phase I ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 78
Study Start Date: January 2004
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bortezomib, CHOP, Rituximab

    Standard CHOP chemotherapy administered every 21 days (full dose) for six cycles

    Rituximab administered (375 mg/m2) day 1 of each cycle (with usual premedications)

    VELCADE is administered prior to rituximab and CHOP on day 1 of each cycle. The dose of VELCADE will be determined by the following dose escalation schedule:

    Level Dose/Schedule

    • 2 0.7 mg/m2 on day 1 of each cycle
    • 1 0.7 mg/m2 on days 1 and 8 0 0.7 mg/m2 on days 1 and 4

      • 1 1.0 mg/m2 on days 1 and 4
      • 2 1.3 mg/m2 on days 1 and 4
  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed diagnosis of diffuse large B cell or mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profiles. For mantle cell: CD5(+), CD19(+) or CD20(+), cyclin D1(+), CD23(-) and CD10(-).
  • Patient has not received any prior anti-cancer therapy for lymphoma
  • Tumor tissue confirmed to express the CD20 antigen
  • Available frozen tumor tissue(rebiopsy if needed)
  • Patient has measurable disease as defined by a tumor mass > 1.5 cm
  • Patient has Stage II, III, or IV disease
  • Age > 18 years
  • Absolute granulocyte count > 1000 cells/mm3
  • Platelet count > 50,000 cells/mm3
  • Creatinine < 2.0 x ULN
  • Total bilirubin < 2.0 x ULN

Exclusion Criteria:

  • Known central nervous system (CNS) involvement by lymphoma
  • Known HIV disease
  • Patient is pregnant or nursing
  • Patient has had major surgery within the last 3 weeks
  • Patient is receiving other investigational drugs
  • Known peripheral neuropathy > Grade 2
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151320

Locations
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Nebraska
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New York
Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032
Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: John P Leonard, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: John P. Leonard, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00151320     History of Changes
Other Study ID Numbers: 0309006313, i34103-049
Study First Received: September 6, 2005
Last Updated: July 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
diffuse large B cell
mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014