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Denileukin Diftitox in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00138164
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : May 30, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Biological therapies, such as denileukin diftitox, may be able to carry cancer-killing substances directly to non-Hodgkin's lymphoma cells.

PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: denileukin diftitox Phase 2

Detailed Description:



  • Determine the efficacy of denileukin diftitox, in terms of objective response and time to progression, in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.


  • Determine the safety of this drug in these patients.
  • Determine the 1-year overall survival of patients treated with this drug.

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

Patients receive denileukin diftitox IV over 20-80 minutes on days 1-3, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, and 99 (weeks 1-16) in the absence of disease progression or unacceptable toxicity. Patients achieving a partial response at week 16 may continue treatment once monthly for up to 8 additional doses or until a complete response (CR) is achieved. Patients achieving a CR (at any time) receive 2 additional monthly doses of denileukin diftitox beyond CR.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 1 year.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Multicenter Study of Ontak® (Denileukin Diftitox) in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
Study Start Date : December 2004
Primary Completion Date : February 2006
Study Completion Date : November 2008

Primary Outcome Measures :
  1. Objective clinical response (complete or partial response)

Secondary Outcome Measures :
  1. Time to progression
  2. Overall survival at 1 year
  3. Safety

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL) of 1 of the following subtypes:

    • Diffuse large B-cell lymphoma
    • Follicular lymphoma (grades 1-3)
    • Small lymphocytic lymphoma
    • Transformed B-cell lymphoma
  • Relapsed or refractory disease

    • Disease failed to respond to or progressed after ≥ 2 prior treatment regimens (e.g., high-dose therapy [HDT] with stem cell transplantation [SCT]*) NOTE: *Patients who have received HDT with SCT are considered to have diminished bone marrow reserve
  • Diminished bone marrow reserve AND/OR mild to moderate cytopenia, meeting 1 of the following criteria:

    • Absolute neutrophil count ≥ 1,000/mm^3 but < 1,500/mm^3 (growth factor independent)
    • WBC ≥ 2,000/mm^3 but < 4,000/mm^3 (growth factor independent)
    • Platelet count ≥ 40,000/mm^3 (25,000/mm^3 if thrombocytopenia is secondary to marrow involvement by lymphoma) but < 150,000/mm^3 (platelet transfusion independent)
  • At least 1 bidimensionally measurable lymph node or tumor mass ≥ 4 cm



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 16 weeks


  • See Disease Characteristics


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2 times ULN
  • Albumin ≥ 3.0 g/dL
  • No history of veno-occlusive disease of the liver
  • No chronic hepatitis


  • Creatinine < 2 times ULN


  • No congestive heart failure
  • No New York Heart Association class III-IV cardiac disease
  • No ventricular tachycardia
  • No fibrillation
  • No myocardial infarction within the past 12 months


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No known HIV positivity
  • No active GVHD ≥ grade 2 within the past 6 months
  • No other serious medical illness or active infection that would preclude study participation
  • No known hypersensitivity to denileukin diftitox or any of its components (e.g., diphtheria toxin, interleukin-2, or their excipients)
  • No other malignancy within the past 5 years except successfully treated carcinoma in situ of the cervix or basal cell carcinoma


Biologic therapy

  • See Disease Characteristics
  • At least 6 months since prior allogeneic SCT
  • No concurrent immunotherapy


  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent anticancer hormonal therapy
  • No concurrent corticosteroids for the treatment of NHL
  • Concurrent corticosteroids allowed for the following conditions:

    • Tapering doses of corticosteroids for resolving graft-versus-host disease (GVHD)
    • Low-dose maintenance corticosteroids for the treatment of an autoimmune disorder
    • Corticosteroids as premedication prior to denileukin diftitox administration or as transient treatment for hypersensitivity reactions


  • More than 4 weeks since prior and no concurrent radiotherapy
  • No prior radiotherapy to the only site of evaluable disease unless disease progression has occurred at that site


  • Not specified


  • At least 3 weeks since prior antilymphoma therapy
  • More than 4 weeks since prior and no other concurrent experimental therapy, including approved drugs tested in an investigational setting

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138164

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Lauren C. Pinter-Brown, MD Jonsson Comprehensive Cancer Center

ClinicalTrials.gov Identifier: NCT00138164     History of Changes
Other Study ID Numbers: LIGAND-PIND-123
CDR0000439451 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: November 2008

Keywords provided by National Cancer Institute (NCI):
recurrent adult diffuse large cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent small lymphocytic lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Denileukin diftitox
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs