NCT00149136

Brief Summary

ALL patients aged 55 years or older were treated with steroids during one week and Ph+ve cases were then offered a specific therapy including an induction treatment with steroids, cyclophosphamide, daunorubicin and vincristine, followed, irrespective of response to induction chemotherapy, by imatinib, 600 mg daily, combined with intermittent steroids during 2 months. Patients in complete response (CR) were then given 10 blocks of alternating chemotherapy, including 2 additional two-month blocks of imatinib, for a total treatment duration of 2 years. Therapy of occult central nervous system leukemia included 5 intrathecal injections of methotrexate and cranial irradiation. Duration of therapy : 2 years.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

April 27, 2007

Status Verified

April 1, 2007

First QC Date

September 6, 2005

Last Update Submit

April 26, 2007

Conditions

Acute Lymphocytic Leukemia

Keywords

Acute Lymphocytic Leukemia,Ph+,elderly patients,Imatinib

Outcome Measures

Primary Outcomes (1)

  • Impact of Imatinib on survival in elderly patients with Ph+ALL

Secondary Outcomes (6)

  • Tolerance of Imatinib

  • Complete remission rate

  • Minimal Residual Disease after Imatinib treatment

  • Leukemia free survival

  • Impact of steroids given before starting chemotherapy

  • +1 more secondary outcomes

Interventions

imatinibDRUG

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ph+ ALL patients
  • years or older
  • Signed written informed consent

You may not qualify if:

  • CML in transformation
  • Concomitant malignancy
  • Previous treatment by Imatinib
  • Severe organ condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xavier THOMAS

Lyon, 69437, France

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Xavier THOMAS, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

August 1, 2002

Last Updated

April 27, 2007

Record last verified: 2007-04

Locations

FR(1)