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Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia (LAL0904)

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ClinicalTrials.gov Identifier: NCT00458848
Recruitment Status : Completed
First Posted : April 11, 2007
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions 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
Enrollment 470
Recruitment Details  
Pre-assignment Details We are reporting on the subset of patients that was treated according to amendment three, in which Imatinib was given only at induction.
Arm/Group Title Philadelphia Positive, Imatinib Only in Induction Therapy
Hide Arm/Group Description These subset of patients was treated according to amendment three, in which Imatinib was given only at induction.
Period Title: Overall Study
Started 51
Completed 51
Not Completed 0
Arm/Group Title Philadelphia Positive, Imatinib Only in Induction Therapy
Hide Arm/Group Description

In this protocol, adult Philadelphia positive acute lymphoblastic leukemia patients were treated with chemotherapy for induction and consolidation, followed by maintenance with imatinib. The protocol was subsequently amended and imatinib was incorporated in the induction and post-remission phase together with chemotherapy. Due to the toxicity of this combined approach, the protocol was further amended to a sequential scheme based on imatinib plus steroids as induction, followed by consolidation with chemotherapy plus imatinib and, when applicable, by a hematopoietic stem cell transplant.

Thus, we have analyzed only this subset of patients as it was not feasible to analyzed all patients enrolled due also to the disease itself.

Overall Number of Baseline Participants 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 51 participants
45.94
(16.99 to 59.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
28
  54.9%
Male
23
  45.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 51 participants
51
White Blood Cells (WBC) at diagnosis-nsr  
Median (Full Range)
Unit of measure:  10^9 cells/L
Number Analyzed 51 participants
28.00
(1.40 to 597.00)
BCR transcript-molecular at diagnosis  
Measure Type: Number
Unit of measure:  Participants
p190 Number Analyzed 51 participants
39
p210 Number Analyzed 51 participants
7
p190/p210 Number Analyzed 51 participants
5
Pre-treatment response  
Measure Type: Number
Unit of measure:  Participants
Non responder-blasts reduction <75% Number Analyzed 51 participants
10
Responder-blasts reduction >=75% Number Analyzed 51 participants
38
Frequency missing Number Analyzed 51 participants
3
1.Primary Outcome
Title Percentage of Participants Reaching Disease Free Survival
Hide Description [Not Specified]
Time Frame At 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Philadelphia Positive, Imatinib Only in Induction Therapy
Hide Arm/Group Description:

In this protocol, adult Philadelphia positive acute lymphoblastic leukemia patients were treated with chemotherapy for induction and consolidation, followed by maintenance with imatinib. The protocol was subsequently amended and imatinib was incorporated in the induction and post-remission phase together with chemotherapy. Due to the toxicity of this combined approach, the protocol was further amended to a sequential scheme based on imatinib plus steroids as induction, followed by consolidation with chemotherapy plus imatinib and, when applicable, by a hematopoietic stem cell transplant.

Thus, we have analyzed only this subset of patients as it was not feasible to analyzed all patients enrolled due also to the disease itself.

Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: percentage of participants
45.8
2.Secondary Outcome
Title Number of Patients Reaching Complete Hematological Response After Induction Therapy
Hide Description [Not Specified]
Time Frame At the end of induction, day +50
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Philadelphia Positive, Imatinib Only in Induction Therapy
Hide Arm/Group Description:

In this protocol, adult Philadelphia positive acute lymphoblastic leukemia patients were treated with chemotherapy for induction and consolidation, followed by maintenance with imatinib. The protocol was subsequently amended and imatinib was incorporated in the induction and post-remission phase together with chemotherapy. Due to the toxicity of this combined approach, the protocol was further amended to a sequential scheme based on imatinib plus steroids as induction, followed by consolidation with chemotherapy plus imatinib and, when applicable, by a hematopoietic stem cell transplant.

Thus, we have analyzed only this subset of patients as it was not feasible to analyzed all patients enrolled due also to the disease itself.

Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: participants
49
3.Secondary Outcome
Title Percentage of Participants Reaching Overall Survival
Hide Description Overall survival from diagnosis
Time Frame At 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Philadelphia Positive, Imatinib Only in Induction Therapy
Hide Arm/Group Description:

In this protocol, adult Philadelphia positive acute lymphoblastic leukemia patients were treated with chemotherapy for induction and consolidation, followed by maintenance with imatinib. The protocol was subsequently amended and imatinib was incorporated in the induction and post-remission phase together with chemotherapy. Due to the toxicity of this combined approach, the protocol was further amended to a sequential scheme based on imatinib plus steroids as induction, followed by consolidation with chemotherapy plus imatinib and, when applicable, by a hematopoietic stem cell transplant.

Thus, we have analyzed only this subset of patients as it was not feasible to analyzed all patients enrolled due also to the disease itself.

Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: percentage of patients
48.8
Time Frame 34 months
Adverse Event Reporting Description Only serious adverse events are reported.
 
Arm/Group Title Philadelphia Positive, Imatinib Only in Induction Therapy
Hide Arm/Group Description

In this protocol, adult Philadelphia positive acute lymphoblastic leukemia patients were treated with chemotherapy for induction and consolidation, followed by maintenance with imatinib. The protocol was subsequently amended and imatinib was incorporated in the induction and post-remission phase together with chemotherapy. Due to the toxicity of this combined approach, the protocol was further amended to a sequential scheme based on imatinib plus steroids as induction, followed by consolidation with chemotherapy plus imatinib and, when applicable, by a hematopoietic stem cell transplant.

Thus, we have analyzed only this subset of patients as it was not feasible to analyzed all patients enrolled due also to the disease itself.

All-Cause Mortality
Philadelphia Positive, Imatinib Only in Induction Therapy
Affected / at Risk (%)
Total   2/51 (3.92%)    
Show Serious Adverse Events Hide Serious Adverse Events
Philadelphia Positive, Imatinib Only in Induction Therapy
Affected / at Risk (%) # Events
Total   7/51 (13.73%)    
Gastrointestinal disorders   
Abdominal pain *  1/51 (1.96%)  1
General disorders   
Death *  2/51 (3.92%)  2
Pyrexia *  1/51 (1.96%)  1
Nervous system disorders   
Headache *  1/51 (1.96%)  1
Respiratory, thoracic and mediastinal disorders   
Hypoxia *  1/51 (1.96%)  1
Vascular disorders   
Intra-abdominal haematoma *  1/51 (1.96%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Philadelphia Positive, Imatinib Only in Induction Therapy
Affected / at Risk (%) # Events
Total   0/51 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alfonso Piciocchi
Organization: GIMEMA
Phone: +39 06 70390513
EMail: a.piciocchi@gimema.it
Layout table for additonal information
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00458848     History of Changes
Other Study ID Numbers: LAL0904
LAL0904 ( Other Identifier: GIMEMA )
2004-001738-11 ( Other Identifier: EudraCT )
First Submitted: April 9, 2007
First Posted: April 11, 2007
Results First Submitted: November 21, 2017
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019