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An Open-Labeled, Phase II Study of Rituximab in Combination With Recombinant IL-2 for Relapsed or Refractory Non-Hodgkin's Lymphoma of Intermediate- or High-Grade Histology

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

An Open-Labeled, Phase II Study of Rituximab in Combination With Recombinant IL-2 for Relapsed or Refractory Non-Hodgkin's Lymphoma of Intermediate- or High-Grade Histology


- Determine the clinical efficacy of rituximab and interleukin-2 in patients with
relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.

- Determine the 2-year progression-free survival of patients treated with this regimen.

- Determine the safety of this regimen in these patients.

- Correlate response with natural killer cell numbers and rituximab, interleukin-2
(IL-2), and soluble IL-2 receptor levels in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive rituximab IV once weekly on weeks 1-4 and interleukin-2 subcutaneously 3
times weekly on weeks 2-9. Treatment continues in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 12 weeks for 2 years.

PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study.

Inclusion Criteria


- Diagnosis of intermediate- or high-grade non-Hodgkin's lymphoma according to the
Working Formulation, including the following subtypes:

- Diffuse large cell lymphoma

- Diffuse mixed cell lymphoma

- Immunoblastic large cell lymphoma

- CD20+ disease

- Measurable progressive or refractory disease

- No primary CNS lymphoma or lymphomatous meningitis NOTE: A new classification scheme
for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of
"indolent" or "aggressive" lymphoma will replace the former terminology of "low",
"intermediate", or "high" grade lymphoma. However, this protocol uses the former



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified


- Lymphocyte count less than 20,000/mm^3

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 75,000/mm^3

- Hemoglobin at least 9.5 g/dL


- SGOT and SGPT no greater than 1.5 times upper limit of normal

- Bilirubin normal

- No liver disease

- Hepatitis C-seropositive patients are allowed provided they have no active disease,
as demonstrated by any of the following:

- Undetectable hepatitis C viral loads

- Biopsy showing no active disease

- Normal transaminases on at least 3 different occasions within the past year


- Creatinine normal


- No clinically significant cardiac dysfunction

- No myocardial infarction within the past 6 months

- No heart failure within the past 6 months


- No clinically significant pulmonary dysfunction

- Patients with prior radiotherapy to the lung or autologous transplantation must have
FEV greater than 50% and DLCO greater than 50% within 8 weeks before study treatment


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No significant infections within the past 2 weeks (including pneumonia or bronchitis)

- No history of autoimmune disease

- No prior or concurrent malignancy except inactive nonmelanoma skin cancer, carcinoma
in situ of the cervix, or other solid tumor curatively treated with no evidence of
recurrence within the past 2 years

- No symptomatic thyroid disease requiring medical intervention other than replacement
treatment for hypothyroidism

- No prior type 1 hypersensitivity or anaphylactic reactions to murine products,
rituximab, or radioimmunoconjugated anti-CD20 antibody infusion


Biologic therapy

- At least 3 months since prior autologous bone marrow transplantation

- No prior allogeneic bone marrow transplantation

- No prior interleukin-2

- No prior interferon (alfa, beta, or gamma)

- No concurrent basiliximab, daclizumab, or monoclonal antibody OKT3


- More than 30 days since prior chemotherapy

- No concurrent anticancer chemotherapy

Endocrine therapy

- More than 2 weeks since prior systemic steroids

- No concurrent systemic corticosteroids


- More than 30 days since prior radiotherapy

- No concurrent radiotherapy


- More than 30 days since prior major surgery


- More than 30 days since other prior investigational drugs

- More than 30 days since prior immunosuppressive medications

- No concurrent immunosuppressive medications including the following:

- Cyclosporine

- Mycophenolate mofetil

- Tacrolimus

- Sirolimus

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Tarun Kewalramani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2003

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Memorial Sloan-Kettering Cancer Center New York, New York  10021