NCT00082940

Brief Summary

RATIONALE: Biological therapies, such as denileukin diftitox, may interfere with the growth of cancer cells and slow the growth of chronic lymphocytic leukemia. PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with fludarabine-refractory B-cell chronic lymphocytic leukemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2002

Shorter than P25 for phase_2 leukemia

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

January 19, 2017

Status Verified

June 1, 2013

Enrollment Period

2.4 years

First QC Date

May 14, 2004

Last Update Submit

January 17, 2017

Conditions

Leukemia

Keywords

B-cell chronic lymphocytic leukemiarefractory chronic lymphocytic leukemia

Interventions

denileukin diftitoxBIOLOGICAL

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (11)

St. Joseph Hospital Regional Cancer Center - Orange

Orange, California, 92868-3849, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

Medical Center Vincennes

Vincennes, Indiana, 47591, United States

Location

Cancer Care Specialists

Houma, Louisiana, 70360, United States

Location

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, 71130-3932, United States

Location

Josephine Ford Cancer Center at Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Southeastern Medical Oncology Center

Goldsboro, North Carolina, 27534, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Chattanooga Oncology and Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Southwest Regional Cancer Center - Central

Austin, Texas, 78705, United States

Location

Related Publications (1)

  • Frankel AE, Surendranathan A, Black JH, White A, Ganjoo K, Cripe LD. Phase II clinical studies of denileukin diftitox diphtheria toxin fusion protein in patients with previously treated chronic lymphocytic leukemia. Cancer. 2006 May 15;106(10):2158-64. doi: 10.1002/cncr.21851.

    PMID: 16586495RESULT

MeSH Terms

Conditions

LeukemiaLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

denileukin diftitox

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, B-CellLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arthur E. Frankel, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2004

First Posted

May 19, 2004

Study Start

August 1, 2002

Primary Completion

January 1, 2005

Study Completion

June 1, 2005

Last Updated

January 19, 2017

Record last verified: 2013-06

Locations

US(11)