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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
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

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

Authority:

United States: Federal Government

Study ID:

CCCWFU-27102

NCT ID:

NCT00082940

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

Name

Location

Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Josephine Ford Cancer Center at Henry Ford Health SystemDetroit, Michigan  48202
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
St. Joseph Hospital Regional Cancer Center - OrangeOrange, California  92868-3849
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Cancer Care SpecialistsHouma, Louisiana  70360
Southeastern Medical Oncology CenterGoldsboro, North Carolina  27534
Medical Center VincennesVincennes, Indiana  47591
Chattanooga Oncology and Hematology AssociatesChattanooga, Tennessee  37404
Southwest Regional Cancer Center - CentralAustin, Texas  78705