NCT00558961

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2005

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

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

October 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

3.5 years

First QC Date

November 15, 2007

Last Update Submit

March 23, 2023

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLLchronic lymphocytic leukemialeukemiagleevecchlorambucil

Outcome Measures

Primary Outcomes (1)

  • Measure number of patients at maximum tolerated dose of Gleevec in combination with chlorambucil

    1 month

Secondary Outcomes (3)

  • Report adverse events as a measure of safety

    6 months

  • Report response to treatment as a measure of efficacy

    6 months

  • Report level of gleevec concentration at different doses as a measure of pharmacokinetics

    1 month

Study Arms (1)

I

EXPERIMENTAL

Gleevec Chlorambucil

Drug: Gleevec and Chlorambucil

Interventions

Gleevec and ChlorambucilDRUG

The first cohort will receive Gleevec at 300 mg daily on days 1-10 and chlorambucil 8mg/m2/d from day 3-7. This will be repeated every 28 days. Cohort 2 will receive 400 mg Gleevec and Cohort 3 will receive 600 mg Gleevec. Each dose level may be expanded up to 6 patients if 1 of 3 patients experiences any dose limiting toxicities.

Also known as: Gleevec (imatinib mesylate), Chlorambucil
I

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Documented prolymphocytic leukemia (PLL; prolymphocytes, 55% in blood)
  • Active cardiovascular disease as defined by NYHA class III-IV categorization.
  • Intercurrent illness or medical condition precluding safe administration 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charles Lemoyne Hospital

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Jewish General Hospital

Montreal, Quebec, H4T 1E2, Canada

Location

Related Publications (1)

  • 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. doi: 10.1038/sj.leu.2403247.

    PMID: 14712290BACKGROUND

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLeukemia

Interventions

Imatinib MesylateChlorambucil

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, Halogenated

Study Officials

  • Sarit Assouline, MD

    Jewish General Hospital

    PRINCIPAL INVESTIGATOR

  • Lawrence Panasci, MD

    Jewish General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Oncology, McGill University

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 16, 2007

Study Start

October 1, 2005

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

March 27, 2023

Record last verified: 2023-03

Locations

CA(2)