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A Phase II Study of PS-341 (Bortezomib) in Patients With Relapsed or Refractory Hodgkin's Lymphoma

Phase 2
18 Years
Not Enrolling
Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma, Recurrent Adult Hodgkin Lymphoma

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Trial Information

A Phase II Study of PS-341 (Bortezomib) in Patients With Relapsed or Refractory Hodgkin's Lymphoma


I. To evaluate the efficacy of bortezomib in patients with relapsed or refractory Hodgkin's
lymphoma using overall response rate as the primary efficacy endpoint.

II. To assess time to progression and 2-year overall survival after bortezomib therapy.

III. To evaluate the safety and tolerability of bortezomib in patients with
relapsed/refractory Hodgkin's lymphoma.

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats
every 21 days for up to 8 courses in the absence of rapid disease progression or
unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

Inclusion Criteria:

- Histologically confirmed classical Hodgkin's lymphoma

- No bone marrow biopsies or fine needle aspirates as the sole means of diagnosis

- Core biopsies allowed if they contain adequate tissue for primary diagnosis

- The following subtypes are allowed:

- Nodular sclerosis

- Lymphocyte rich

- Mixed cellularity

- Lymphocyte depletion

- Classical Hodgkin's lymphoma, not otherwise specified

- No nodular lymphocyte-predominant Hodgkin's lymphoma

- Relapsed or refractory disease after at least 1 prior standard systemic cytotoxic
chemotherapy regimen

- Measurable disease by physical exam or imaging studies

- Any tumor mass > 1 cm is allowed

- No non-measurable disease only, including the following:

- Bone lesions

- Ascites

- Pleural or pericardial effusion

- Lymphangitis cutis/pulmonis

- Bone marrow

- No curative option available with high-dose therapy and stem cell transplantation

- Performance status - 0-2

- Absolute neutrophil count ≥ 750/mm^3

- Platelet count ≥ 75,000/mm^3

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST ≤ 2.5 times ULN

- Creatinine ≤ 2.5 mg/dL

- No sensory or motor peripheral neuropathy ≥ grade 2

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for up to 3 months after
study participation

- See Disease Characteristics

- Prior stem cell transplantation allowed

- See Disease Characteristics

- No concurrent chemotherapy

- No concurrent dexamethasone or other steroidal antiemetics

- Concurrent steroids for adrenal failure allowed

- Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for
diabetes) allowed

- Prior radiotherapy to a symptomatic lesion or one that may produce disability (e.g.,
unstable femur) is allowed provided other measurable disease is present

- No concurrent palliative radiotherapy

- Recovered from all prior treatment

- No prior bortezomib or other proteosome inhibitors

Type of Study:


Study Design:

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

Outcome Measure:

Overall response rate

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Nancy Bartlett

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

March 2004

Completion Date:

Related Keywords:

  • Adult Lymphocyte Depletion Hodgkin Lymphoma
  • Adult Mixed Cellularity Hodgkin Lymphoma
  • Adult Nodular Sclerosis Hodgkin Lymphoma
  • Recurrent Adult Hodgkin Lymphoma
  • Hodgkin Disease
  • Lymphoma
  • Sclerosis



Cancer and Leukemia Group B Chicago, Illinois  60606