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A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Mantle Cell Lymphoma

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase II Study Of PS-341 (NSC 681239) In Patients With 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

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

Inclusion Criteria


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Principal Investigator

Andrew R. Belch, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cross Cancer Institute at University of Alberta


United States: Federal Government

Study ID:




Start Date:

July 2002

Completion Date:

December 2009

Related Keywords:

  • Lymphoma
  • stage I mantle cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell