Trial | NCT00458848  Report issue

Title

Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia
Phase II Study of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Study Participants

    470
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia.

Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category.
Study Started
Oct 31
2004
Primary Completion
Mar 31
2014
Study Completion
Mar 31
2014
Results Posted
Feb 15
2019
Last Update
Feb 15
2019

Drug asparaginase

Drug daunorubicin hydrochloride

Drug etoposide

Drug idarubicin

Drug imatinib mesylate

Drug mercaptopurine

Drug methotrexate

Drug methylprednisolone

Drug mitoxantrone hydrochloride

Drug prednisone

Drug vincristine sulfate

Procedure allogeneic hematopoietic stem cell transplantation

Procedure autologous hematopoietic stem cell transplantation

Procedure peripheral blood stem cell transplantation

Radiation radiation therapy

Criteria 

DISEASE CHARACTERISTICS:

Diagnosis of acute lymphoblastic leukemia (ALL) meeting the following criteria:

Negative myeloperoxidase stain
Phenotype T (T-ALL) or B (B-ALL)
No mature B-ALL (FAB L3, serum immunoglobulin-positive, terminal deoxynucleotidyl transferase-negative)

PATIENT CHARACTERISTICS:

Creatinine ≤ 2.5 mg/dL (after adequate hydration)
SGOT and SGPT ≤ 3 times upper limit of normal
LVEF ≥ 50%
No severe psychiatric disorders
No other concurrent malignant disease
No presence of documented infections not responding to antibiotic and/or antifungal therapy
Not pregnant

PRIOR CONCURRENT THERAPY:

No prior steroids
No prior antiblastic chemotherapy
No other concurrent chemotherapy or radiotherapy

Summary

Philadelphia Positive, Imatinib Only in Induction Therapy

All Events

Event Type Organ System Event Term Philadelphia Positive, Imatinib Only in Induction Therapy

Percentage of Participants Reaching Disease Free Survival

Philadelphia Positive, Imatinib Only in Induction Therapy

45.8
percentage of participants

Number of Patients Reaching Complete Hematological Response After Induction Therapy

Philadelphia Positive, Imatinib Only in Induction Therapy

49.0
participants

Percentage of Participants Reaching Overall Survival

Overall survival from diagnosis

Philadelphia Positive, Imatinib Only in Induction Therapy

48.8
percentage of patients

Age, Continuous

45.94
years (Median)
Full Range: 16.99 to 59.7

White Blood Cells (WBC) at diagnosis-nsr

28.00
10^9 cells/L (Median)
Full Range: 1.4 to 597.0

BCR transcript-molecular at diagnosis

Pre-treatment response

Region of Enrollment

Sex: Female, Male

Overall Study

Philadelphia Positive, Imatinib Only in Induction Therapy