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Randomized Phase II Study Of Interleukin-12 In Combination With Rituximab In Patients With Non-Hodgkin's Lymphoma

Phase 2
18 Years
Not Enrolling
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Small Lymphocytic Lymphoma, Splenic Marginal Zone Lymphoma

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Trial Information

Randomized Phase II Study Of Interleukin-12 In Combination With Rituximab In Patients With Non-Hodgkin's Lymphoma


I. Compare the objective response in patients with B-cell non-Hodgkin's lymphoma treated
with rituximab and 2 different schedules of interleukin-12*.

II. Compare the toxic effects of these regimens in these patients. III. Determine the
objective response rate in patients with mantle cell lymphoma treated with these regimens.

IV. Determine the overall and progression-free survival of patients treated with these

V, Compare the quality of life of patients treated with these regimens. NOTE:
*Interleukin-12 will no longer be available after 6/30/05.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
histology (mantle cell lymphoma vs other [closed to accrual as of 3/10/04]) and
International Prognostic Factor Index (low and low-intermediate risk [closed to accrual as
of 3/10/04] vs high-intermediate and high risk). Patients are randomized to 1 of 2 treatment

ARM I: Patients receive rituximab IV on days 1, 8, 15, and 22. Patients receive
interleukin-12* subcutaneously (SC) twice weekly beginning on day 2 and continuing until
disease progression.

ARM II (closed to accrual as of 11/14/03): Patients receive rituximab as in arm I. Patients
are evaluated at week 12. Patients with stable or progressive disease receive
interleukin-12* SC twice weekly until disease progression or for 24 weeks. Patients with a
complete or partial response after rituximab are monitored until disease progression and
then begin interleukin-12 SC twice weekly until further disease progression.

NOTE: *Interleukin-12 will no longer be available after 06/30/05. Patients proceed to
follow-up as outlined below.

Quality of life is assessed at baseline and at 3 and 6 months.

Patients are followed every 3 months for 1 year and then every 6 months for up to 4 years.

PROJECTED ACCRUAL: A total of 90 patients (45 per treatment arm [arm II closed to accrual as
of 11/14/03]) will be accrued for this study within 3 years.

Inclusion Criteria:

- Histologically confirmed CD20-positive B-cell non-Hodgkin's lymphoma

- Previously treated low-grade lymphoma considered incurable with standard therapy

- Grade I or II follicular lymphoma*

- Lymphoplasmacytic lymphoma*

- Small lymphocytic lymphoma*

- Nodal marginal zone lymphoma*

- Extranodal marginal zone lymphoma of MALT type*

- Splenic marginal zone lymphoma*

- Previously treated mantle cell lymphoma allowed

- Meets one of the following criteria for measurable disease:

- Bidimensional diameter at least 1.5 cm by 1.5 cm on physical exam

- At least 2 cm in one dimension by CT scan, MRI, or plain radiograph imaging

- Palpable spleen at least 5 cm below the left costal margin

- No CNS involvement by lymphoma

- Performance status - ECOG 0-1

- At least 12 weeks

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 75,000/mm^3

- Hemoglobin ≥ 8 g/dL

- Bilirubin ≤ 3 times upper limit of normal (ULN)

- AST and ALT ≤ 3 times ULN

- Alkaline phosphatase ≤ 3 times ULN

- Creatinine ≤ 2 times ULN

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

- No history of angina

- No uncontrolled peptic ulcer disease

- No uncontrolled infection

- No other active malignancy

- No autoimmune-related phenomena (e.g., antinuclear antibody less than 2 times ULN,
rheumatoid factor less than 2 times ULN, and negative direct Coombs)

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Prior stem cell transplantation allowed

- More than 12 months since prior rituximab

- No prior interleukin-12

- No other concurrent immunotherapy

- Recovered from prior chemotherapy

- No concurrent chemotherapy

- No concurrent steroid therapy

- No concurrent radiotherapy

- Any number of prior therapies allowed

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response

Outcome Description:

The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. In addition, confidence intervals for the response probability will be calculated according to the approach of Duffy and Santner.

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Stephen Ansell

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group


United States: Food and Drug Administration

Study ID:




Start Date:

October 2001

Completion Date:

Related Keywords:

  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Nodal Marginal Zone B-cell Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell



North Central Cancer Treatment Group Rochester, Minnesota  55905