Phase II Study of ONTAK in Previously Treated Patients With Low-grade Non-Hodgkin's Lymphoma (NHL)

NCT00051025 | Completed Phase 2 Results

• 1 other identifier: L4389-30
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to look at the safety and effectiveness of ONTAK in previously treated patients with NHL.

Conditions

Non-Hodgkin's Lymphoma; Lymphoma, B-cell; Lymphoma, Low-grade

Outcome Measures

Primary Outcomes (1)

• Objective Clinical Response: Complete Response (CR) or Partial Response (PR) at Week 24, or, in the Event of Lengthened Cycle Intervals, at the End of Cycle 8.

  Complete response: achievement of a complete regression for \>4 weeks of all palpable and x-ray demonstrable disease and bone marrow disease. Partial response: response to therapy with a 75% reduction in the greatest diameters of the measurable lesions for \>4 weeks and had indeterminate bone marrow biopsy

  24 Weeks

Secondary Outcomes (2)

• Duration of Response

  From beginning of response to time of relapse

• Time-to-Treatment Failure

  From start of first treatment

Interventions

ONTAK DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological diagnosis of low-grade (indolent), B-cell, non-Hodgkin's lymphoma.
• Positive expression for CD25 of tumor cells in a lymph node biopsy as defined by greater than 20% of malignant cells staining for CD25 by standardized immunohistochemical assay.
• Modified Ann Arbor Stage I, II, III or IV.
• Patients must have received at least two but no more than five prior therapies. One prior therapy must have been cytotoxic chemotherapy and one prior therapy must have been monoclonal antibody therapy. Combination chemotherapy, including regimens used prior to bone marrow transplantation, will count as a single therapy for purposes of eligibility.
• Patients must have bidimensionally measurable disease.
• Patients must be 18 years of age or older.
• An ECOG performance status of 0, 1, or 2.
• Acceptable organ function defined as follows:
• absolute neutrophil count (ANC) \> or = to 1,000/mm3, platelet count \> or = to 50,000/mm3, Hemoglobin \> or = to 8 g/dL;
• Bilirubin \< or = to 1.5 times the upper limit of normal (ULN);
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< or = to 1.5 times the upper limit of normal;
• Serum creatinine \<1.8mg/dL;
• Serum albumin \> or = to 3.0 g/dL.
• New York Heart Association classification of I or II and no history of poorly controlled hypertension.
• Must be free of serious concurrent illness.

You may not qualify if:

• Patients with cutaneous T-cell lymphoma.
• Patients previously treated with ONTAK (DAB389lL-2) or DAB486IL-2.
• Inability to comply with protocol requirements for this study.
• Pregnant women or lactating women who are breast feeding or women planning to become pregnant during the treatment period or three weeks after their last treatment on protocol.
• Serious intercurrent medical illnesses or active infections requiring parenteral antibiotics, which would interfere with the ability of the patient to carry out the treatment program.
• Sero-positive for human immunodeficiency virus (HIV) antibody. History of ongoing Hepatitis B or Hepatitis C infection.
• Another malignancy or history of another cancer with less than five disease-free years (other than resected basal or squamous cell skin cancers or in situ cervical cancer).
• Patients with a known hypersensitivity to ONTAK or any of its components: diphtheria toxin, interleukin-2, or excipients.
• Any investigational agents within one month prior to study entry.
• Prior radiation therapy within four weeks of enrollment or to the only site of evaluable disease.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (2)

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Hematology and Oncology Services

Metairie, Louisiana, 70006, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, B-Cell

Interventions

denileukin diftitox

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Eisai Inc
• Organization: Eisai Call Center

888-422-4743

Study Officials

• Elyane Lombardy, M.D.

  Ligand Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 31, 2002
• First Posted: January 3, 2003
• Study Start: May 1, 2000
• Primary Completion: January 1, 2001
• Study Completion: September 1, 2006
• Last Updated: July 13, 2012
• Results First Posted: August 3, 2011

Record last verified: 2012-07

Locations

US (2)