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

September 6, 2005
July 27, 2010
January 2004
June 2010   (final data collection date for primary outcome measure)
determine maximum tolerated dose [ Time Frame: phase I ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00151320 on ClinicalTrials.gov Archive Site
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Phase I/II Trial of VELCADE + CHOP-Rituximab in Untreated DLCBL or Mantle Cell NHL
Phase I/II Trial of VELCADE+ CHOP-Rituximab in Patients With Previously Untreated Diffuse Large B Cell or Mantle Cell Non-Hodgkin's Lymphoma

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
78
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June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00151320
0309006313, i34103-049
Not Provided
John P. Leonard, MD, Weill Cornell Medical College
Weill Medical College of Cornell University
Millennium Pharmaceuticals, Inc.
Principal Investigator: John P Leonard, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP