Bortezomib in Treating Patients With Mantle Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030875
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 9, 2010
Information provided by:
Canadian Cancer Trials Group

February 14, 2002
January 27, 2003
November 9, 2010
July 2002
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00030875 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Bortezomib in Treating Patients With Mantle Cell Lymphoma
A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Mantle Cell Lymphoma

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have previously untreated or relapsed mantle cell lymphoma.


  • Determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed mantle cell lymphoma.
  • Determine the toxicity of this drug in these patients.
  • Correlate suppression of 20S proteasome levels with toxicity of and response to this drug in these patients.
  • Determine the time to progression and response duration in patients treated with this drug.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 courses beyond documentation of CR. Patients with stable disease receive a maximum of 4 courses. Patients with partial response (PR) continue therapy until disease progression or for 2 courses beyond documentation of stable PR.

Patients are followed at 4 weeks and then every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 18-24 months.

Phase 2
Allocation: Non-Randomized
Primary Purpose: Treatment
Drug: bortezomib
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
Not Provided
December 2009
Not Provided


  • Histologically or cytologically confirmed relapsed or untreated mantle cell lymphoma

    • No refractory disease defined as progression while on chemotherapy or within 1 month after completion of chemotherapy
  • At least 1 bidimensionally measurable disease site*

    • Lymph nodes at least 1.5 cm by 1.5 cm by spiral CT scan OR
    • Non-nodal lesions (e.g., skin lesion or nodules) at least 1 cm by 1 cm by MRI, CT scan, or physical exam NOTE: *Bone lesions are not considered bidimensionally measurable disease
  • No pre-existing ascites or pleural effusion
  • No known CNS involvement by lymphoma



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks


  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 75,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST or ALT no greater than 2.5 times ULN


  • Creatinine no greater than 1.5 times ULN


  • LVEF at least 45% by echocardiogram or MUGA


  • No pre-existing shortness of breath greater than grade 1


  • No uncontrolled bacterial, fungal, or viral infections
  • No pre-existing edema greater than grade 1
  • No pre-existing neuropathy greater than grade 1
  • No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other serious illness or medical condition that would preclude study compliance
  • No geographical conditions that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • See Chemotherapy
  • Prior rituximab allowed
  • No prior radioactive monoclonal antibody therapy


  • See Disease Characteristics
  • No prior high-dose chemotherapy with stem cell transplantation
  • No more than 2 prior systemic chemotherapy regimens

    • Same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens
  • No prior flavopiridol
  • At least 6 weeks since prior chemotherapy
  • No concurrent cytotoxic chemotherapy

Endocrine therapy:

  • No concurrent corticosteroids


  • No prior radiotherapy to 25% or more of functioning bone marrow
  • At least 4 weeks since prior radiotherapy (except low-dose nonmyelosuppressive radiotherapy) and recovered
  • No concurrent radiotherapy to the sole site of measurable disease


  • At least 2 weeks since prior major surgery


  • No prior investigational therapy
  • No other concurrent anticancer therapy
  • No other concurrent investigational anticancer therapy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
CDR0000069207 ( Other Identifier: PDQ )
Not Provided
Not Provided
Not Provided
Not Provided
NCIC Clinical Trials Group
Not Provided
Study Chair: Andrew R. Belch, MD Cross Cancer Institute at University of Alberta
Canadian Cancer Trials Group
March 2010

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