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Phase II Study of PS-341 in Low Grade Lymphoproliferative Disorders

Phase 2
18 Years
Not Enrolling
Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma

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Trial Information

Phase II Study of PS-341 in Low Grade Lymphoproliferative Disorders


I. Determine the frequency and duration of complete and partial response rates in patients
with grade I, II, or III follicular lymphoma or mantle cell lymphoma treated with


I. Determine the response of minimal residual disease by polymerase chain reaction (PCR)
detectable or clonotypic PCR minimal residual disease in bone marrow of patients treated
with this regimen.

II. Determine the time to progression and overall survival of patients treated with this

III. Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients are stratified according to disease type (follicular lymphoma vs mantle
cell lymphoma).

Patients receive an infusion of bortezomib over 3-5 seconds once weekly for 4 weeks.
Treatment repeats every 6 weeks in the absence of disease progression or unacceptable
toxicity. Patients who achieve at least a partial response lasting at least 6 months may
receive retreatment.

Patients are followed every 3 months for 1 year and then every 4 months for 2 years.

Inclusion Criteria:

- Histologically or cytologically confirmed lymphoproliferative disorder of 1 of the
following subtypes:

- * Relapsed or refractory grade I, II, or III follicular center cell lymphoma

- Relapsed or refractory mantle cell lymphoma

- Measurable disease for non-Hodgkin's lymphoma (NHL) only

- At least 1 unidimensionally measurable lesion

- At least 2 cm by conventional techniques OR at least 1 cm by spiral CT scan

- Lymph nodes no greater than 1 cm in short axis considered normal

- Absolute lymphocytosis greater than 5,000/mm^3 with B-cell phenotype (CD19, 20,or 23
positive) with more than 30% bone marrow lymphocytes for CLL or other leukemic forms
of NHL

- No known brain metastases

- Performance status - Karnofsky 70-100%

- At least 3 months

- See Disease Characteristics

- Absolute neutrophil count greater than 1,500/mm^3 (500/mm^3 if lymphomatous
involvement of bone marrow)

- Platelet count greater than 50,000/mm^3

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- AST and ALT no greater than 2.5 times ULN (4 times ULN in case of liver metastases)

- Creatinine less than 1.5 times ULN

- No symptomatic congestive heart failure

- No New York Heart Association class III or IV heart disease

- No unstable angina pectoris

- No cardiac arrhythmia

- No myocardial infarction within the past 6 months

- No cerebrovascular accident or transient ischemic attack within the past 6 months

- No history of orthostatic hypotension

- No evidence of acute ischemia or significant conduction abnormality (left anterior
hemiblock in the presence of right bundle branch block or second or third degree
atrioventricular blocks) on electrocardiogram

- No uncontrolled hypertension requiring antihypertensive medication

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Febrile episodes up to 38.5°C allowed if no evidence of active infection

- No other uncontrolled concurrent illness

- No known or active HIV infection

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study entry

- At least 3 months since prior monoclonal antibody therapy (e.g., rituximab)

- No more than 3 prior regimens of conventional cytotoxic chemotherapy

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
and recovered

- At least 1 week since prior steroid therapy

- At least 4 weeks since prior radiotherapy and recovered

- At least 4 weeks since prior major surgery

- No other concurrent investigational agents

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

The response probability will be estimated. The 95% confidence interval will be provided.

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

John Gerecitano

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2001

Completion Date:

Related Keywords:

  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoproliferative Disorders
  • Lymphoma, Mantle-Cell



Memorial Sloan Kettering Cancer Center New York, New York  10021