Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Denileukin Diftitox in Treating Patients With Adult T-Cell Leukemia/Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over NCI NCI-05-C-0185 NCI-P6591, NCT00138190

Special Category: NCI Web site featured trial, NIH Clinical Center trial

Objectives

Primary

1. Determine the antitumor activity of denileukin diftitox, in terms of response rate, time to disease progression, and overall survival, in patients with Tac-expressing HTLV-1-associated adult T-cell leukemia/lymphoma.

Secondary

1. Determine the safety of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed Tac-expressing adult T-cell leukemia/lymphoma (ATL)
  • All stages allowed, including chronic, lymphomatous, or acute (ATL)



• HTLV-1 antibody positive



• More than 10% of malignant cells must express CD25



• Measurable disease, defined as > 10% abnormal (i.e., TAC homogenous strongly expressing) peripheral blood mononuclear cells



• No smoldering ATL



• No symptomatic leukemic meningitis*

 [Note: *Patients with ATL and another HTLV-1-associated disease (e.g., tropical spastic paraparesis) are eligible]

Prior/Concurrent Therapy:

Biologic therapy

• No prior denileukin diftitox
• No concurrent monoclonal antibodies
• No concurrent gammaglobulin

Chemotherapy

• At least 3 weeks since prior cytotoxic chemotherapy for ATL
• No concurrent chemotherapy

Endocrine therapy

• Prior or concurrent corticosteroids allowed

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No concurrent drugs that would affect lymphocytes
• No other concurrent investigational anticancer drugs

Patient Characteristics:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• More than 2 months

Hematopoietic

• Granulocyte count ≥ 1,000/mm³
• Platelet count ≥ 50,000/mm³

Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Bilirubin ≤ 3.0 mg/dL
• Albumin ≥ 2.5 g/dL

Renal

• Creatinine < 2.0 mg/dL

Cardiovascular

• No myocardial infarction within the past 6 months
• No severe coronary artery disease

Other

• Not pregnant
• No nursing during and for 3 months after completion of study treatment
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after completion of study treatment
• HIV negative
• No other serious illness

Expected Enrollment

A total of 9-29 patients will be accrued for this study within 1-2½ years.

Outcomes

Response rate after 2 courses of treatment and then after every course for 1 year

Safety after 2 courses of treatment and then after every 4 courses for 1 year

Outline

This is a non-randomized study.

Patients receive denileukin diftitox IV over 1 hour on days 1-5. Treatment repeats every 14 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of treatment beyond CR.

After completion of study treatment, patients are followed at 4 weeks, every 1-3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

John Janik, MD, Principal investigator		Ph: 301-402-2913 Email: janikj@mail.nih.gov

U.S.A.
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937

Related Information

Featured trial article
Web site for additional information

Registry Information
Official Title		Phase II Study of the Efficacy and Toxicity of Ontak® (Denileukin Diftitox) in the Therapy of Adult T-Cell Leukemia
Trial Start Date		2005-07-07
Trial Completion Date		2010-12-22 (estimated)
Registered in ClinicalTrials.gov		NCT00138190
Date Submitted to PDQ		2005-07-07
Information Last Verified		2008-04-06

Back to Top