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

Phase 2
18 Years
Not Enrolling

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Trial Information

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



- Determine the complete and partial response rate in patients with
fludarabine-refractory B-cell chronic lymphocytic leukemia treated with denileukin


- 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.

Inclusion Criteria


- 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

- 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

- 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

- Refractory or intolerant to fludarabine

- Relapsed within 6 months after completion of fludarabine

- No CNS leukemia

- No mantle cell lymphoma in leukemic phase



- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- More than 2 months


- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 50,000/mm^3

- Hemoglobin ≥ 8 g/dL (transfusion allowed)


- 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


- Creatinine ≤ 1.5 mg/dL OR

- Creatinine clearance ≥ 40 mL/min


- LVEF ≥ 40%


- 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


Biologic therapy

- Prior denileukin diftitox allowed


- See Disease Characteristics

Endocrine therapy

- No concurrent corticosteroids as anti-emetics


- No concurrent radiotherapy


- Not specified


- At least 28 days since prior anticancer therapy and recovered

- No other concurrent antineoplastic drugs

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Arthur E. Frankel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Federal Government

Study ID:




Start Date:

August 2002

Completion Date:

June 2005

Related Keywords:

  • Leukemia
  • B-cell chronic lymphocytic leukemia
  • refractory chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Josephine Ford Cancer Center at Henry Ford Health System Detroit, Michigan  48202
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Feist-Weiller Cancer Center at Louisiana State University Health Sciences Shreveport, Louisiana  71130-3932
St. Joseph Hospital Regional Cancer Center - Orange Orange, California  92868-3849
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Cancer Care Specialists Houma, Louisiana  70360
Southeastern Medical Oncology Center Goldsboro, North Carolina  27534
Medical Center Vincennes Vincennes, Indiana  47591
Chattanooga Oncology and Hematology Associates Chattanooga, Tennessee  37404
Southwest Regional Cancer Center - Central Austin, Texas  78705