Skip to content

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

A Phase II Multicenter Study of Ontak® (Denileukin Diftitox) in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00138164
Enrollment
50
Registered
2005-08-30
Start date
2004-12-31
Completion date
2008-11-30
Last updated
2013-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

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

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Interventions

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Jonsson Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 16 weeks Hematopoietic * See Disease Characteristics Hepatic * 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 Renal * Creatinine \< 2 times ULN Cardiovascular * 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 Other * 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 PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * At least 6 months since prior allogeneic SCT * No concurrent immunotherapy Chemotherapy * 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 Radiotherapy * 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 Surgery * Not specified Other * 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

Design outcomes

Primary

MeasureTime frame
Objective clinical response (complete or partial response)

Secondary

MeasureTime frame
Time to progression
Overall survival at 1 year
Safety

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026