Completed

A Phase II Study of ONTAK® (Denileukin Diftitox, DABIL-2) in Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia

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What is being tested

Data Collection

Who is being recruted

Chronic Disease
+11

+ Hematologic Diseases
+ Immune System Diseases
From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2002
See protocol details

Summary

Principal SponsorWake Forest University Health Sciences
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2002Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the complete and partial response rate in patients with fludarabine-refractory B-cell chronic lymphocytic leukemia treated with denileukin diftitox. Secondary * Determine the toxicity profile of this drug in these patients. * Determine the response rate in patients (regardless of CD25 receptor density) treated with this drug. * Determine the progression-free survival and overall survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive denileukin diftitox IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response after 8 courses proceed to follow-up. Patients achieving a partial response or stable disease after 8 courses may continue treatment at the discretion of the investigator. Patients are followed every 3 months for 1 year and then annually until relapse. PROJECTED ACCRUAL: A total of 12-44 patients will be accrued for this study within 1 year.

Official TitleA Phase II Study of ONTAK® (Denileukin Diftitox, DABIL-2) in Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia 
NCT00082940
Principal SponsorWake Forest University Health Sciences
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Chronic Disease
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Disease Attributes
Criteria

DISEASE CHARACTERISTICS: * Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria at any time during the course of disease (e.g., at initial diagnosis or relapse): * Absolute lymphocytosis \> 5,000/mm\^3 * Lymphocytes must appear mature with \< 55% prolymphocytes * More than 30% of all nucleated cells are lymphoid on bone marrow aspirate smear * Lymphoid infiltrates compatible with bone marrow involvement by CLL on core bone marrow biopsy * Predominant B-cell monoclonal population of cells share the B-cell marker (CD19) with the CD5 antigen in the absence of other pan-T-cell markers by lymphocyte immunophenotyping * High-risk disease OR intermediate-risk disease * Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least 1 of the following criteria: * Massive or progressive splenomegaly and/or adenopathy * Weight loss \> 10% within the past 6 months * Common toxicity grade 2-4 fatigue * Fevers \> 100.5°F OR night sweats for more than 2 weeks without evidence of infection * Progressive lymphocytosis with an increase of \> 50% over a 2-month period or an anticipated doubling time of \< 6 months * Failed at least 1 prior fludarabine regimen, as defined by 1 of the following criteria: * Refractory or intolerant to fludarabine * Relapsed within 6 months after completion of fludarabine * No CNS leukemia * No mantle cell lymphoma in leukemic phase PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-2 Life expectancy * More than 2 months Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 50,000/mm\^3 * Hemoglobin ≥ 8 g/dL (transfusion allowed) Hepatic * Albumin ≥ 3 g/dL * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * No hepatitis B or C infection Renal * Creatinine ≤ 1.5 mg/dL OR * Creatinine clearance ≥ 40 mL/min Cardiovascular * LVEF ≥ 40% Other * No uncontrolled infection * No other concurrent serious illness * No HIV infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use two effective methods of contraception (one must be non-hormonal) during and for at least 1 month after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Prior denileukin diftitox allowed Chemotherapy * See Disease Characteristics Endocrine therapy * No concurrent corticosteroids as anti-emetics Radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * At least 28 days since prior anticancer therapy and recovered * No other concurrent antineoplastic drugs



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 11 locations
Suspended
St. Joseph Hospital Regional Cancer Center - OrangeOrange, United StatesSee the location
Suspended
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, United States
Suspended
Medical Center VincennesVincennes, United States
Suspended
Cancer Care SpecialistsHouma, United States

Completed11 Study Centers
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