Dose Escalation Study of Gleevec and Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

November 15, 2007

Last Updated Date

June 12, 2009

Start Date ^ICMJE

October 2005

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Measure: Maximum tolerated dose of Gleevec in combination with chlorambucil [ Time Frame: 1 month ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00558961 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Measure: Safety [ Time Frame: 6 months ]
Measure: Efficacy [ Time Frame: 6 months ]
Measure: Pharmacokinetics [ Time Frame: 1 month ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Dose Escalation Study of Gleevec and Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia Patients

Official Title ^ICMJE

A Phase I-II Trial of Gleevec (Imatinib Mesylate) in Combination With Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia (CLL) Patients

Brief Summary

The purpose of this study is to determine maximum tolerated dose of Gleevec in combination with Chlorambucil in previously treated CLL patients.

Detailed Description

A recent study by Aloyz et al demonstrated a synergistic effect of imatinib on chlorambucil-mediated cytotoxicity in CLL cells in vitro. Imatinib inhibits c-abl and sensitizes cells to chlorambucil. The Phase I component of the study will determine the maximum tolerated dose and recommended Phase II dose of Gleevec when used in combination with chlorambucil. Once the maximum tolerated dose has been determined, a total of 16 patients will be enrolled in the Phase II component of the study. This study will determine the dose limiting toxicities, pharmacokinetics and pharmacodynamics of Gleevec in combination with chlorambucil.

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Lymphocytic Leukemia

Intervention ^ICMJE

Drug: Gleevec and Chlorambucil

Study Arms / Comparison Groups

Experimental: Gleevec Chlorambucil

Publications *

Aloyz R, Grzywacz K, Xu ZY, Loignon M, Alaoui-Jamali MA, Panasci L. Imatinib sensitizes CLL lymphocytes to chlorambucil. Leukemia. 2004 Mar;18(3):409-14.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

B-cell chronic lymphocytic leukemia (a) Rai stage 0-II with indication for treatment by NCI Working Group Criteria: or (b) Rai stage III or IV.
Received a minimum of one prior chemotherapy regimen. Prior treatment with corticosteroids, immunotherapies, monoclonal antibodies or radiation therapy is permitted.
White blood cell count > 25 x 10^9/L
ECOG 0, 1,or 2.
Adequate renal and hepatic function
Platelets > 75 x 10^9/L, transfusion independent.
Neutrophils > 1.0 x 10^9/L, transfusion independent

Exclusion Criteria:

Documented prolymphocytic leukemia (PLL; prolymphocytes, 55% in blood)
Active cardiovascular disease as defined by NYHA class III-IV categorization.
Intercurrent illness or medical condiation precluding safe adminstration of ribavirin.
Concurrent use of chronic steroids, except as replacement therapy for adrenal insufficiency
Known infection with HIV, Hepatitis B or C.
Concurrent malignancy (other than resected basal or squamous cell skin cancers or in-situ carcinoma).
Received any previous therapy for CLL within 28 days prior to study entry.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00558961

Responsible Party

Study ID Numbers ^ICMJE

CR0506PI, REC:05-054

Study Sponsor ^ICMJE

Jewish General Hospital

Collaborators ^ICMJE

Novartis Pharmaceuticals

Investigators ^ICMJE

Principal Investigator:	Sarit Assouline, MD	Jewish General Hospital
Study Director:	Lawrence Panasci, MD	Jewish General Hospital

Information Provided By

Jewish General Hospital

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP