Trial Outcomes & Findings for Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia (NCT NCT00458848)

NCT ID: NCT00458848

Last Updated: 2019-02-15

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 470 participants
• Primary outcome timeframe: At 60 months
• Results posted on: 2019-02-15

Participant Flow

We are reporting on the subset of patients that was treated according to amendment three, in which Imatinib was given only at induction.

Participant milestones

Measure	Philadelphia Positive, Imatinib Only in Induction Therapy These subset of patients was treated according to amendment three, in which Imatinib was given only at induction.
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Philadelphia Positive, Imatinib Only in Induction Therapy n=51 Participants 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.
Age, Continuous	45.94 years n=51 Participants
Sex: Female, Male Female	28 Participants n=51 Participants
Sex: Female, Male Male	23 Participants n=51 Participants
Region of Enrollment Italy	51 participants n=51 Participants
White Blood Cells (WBC) at diagnosis-nsr	28.00 10^9 cells/L n=51 Participants
BCR transcript-molecular at diagnosis p190	39 participants n=51 Participants
BCR transcript-molecular at diagnosis p210	7 participants n=51 Participants
BCR transcript-molecular at diagnosis p190/p210	5 participants n=51 Participants
Pre-treatment response Non responder-blasts reduction <75%	10 participants n=51 Participants
Pre-treatment response Responder-blasts reduction >=75%	38 participants n=51 Participants
Pre-treatment response Frequency missing	3 participants n=51 Participants

PRIMARY outcome

Timeframe: At 60 months

Outcome measures

Measure

Philadelphia Positive, Imatinib Only in Induction Therapy n=51 Participants 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.

Percentage of Participants Reaching Disease Free Survival

45.8 percentage of participants

SECONDARY outcome

Timeframe: At the end of induction, day +50

Outcome measures

Measure

Philadelphia Positive, Imatinib Only in Induction Therapy n=51 Participants 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.

Number of Patients Reaching Complete Hematological Response After Induction Therapy

49 participants

SECONDARY outcome

Timeframe: At 60 months

Overall survival from diagnosis

Outcome measures

Measure

Philadelphia Positive, Imatinib Only in Induction Therapy n=51 Participants 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.

Percentage of Participants Reaching Overall Survival

48.8 percentage of patients

Adverse Events

Philadelphia Positive, Imatinib Only in Induction Therapy

Serious events: 7 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	Philadelphia Positive, Imatinib Only in Induction Therapy n=51 participants at risk 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.
General disorders Death	3.9% 2/51 • Number of events 2 • 34 months Only serious adverse events are reported.
Nervous system disorders Headache	2.0% 1/51 • Number of events 1 • 34 months Only serious adverse events are reported.
General disorders Pyrexia	2.0% 1/51 • Number of events 1 • 34 months Only serious adverse events are reported.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.0% 1/51 • Number of events 1 • 34 months Only serious adverse events are reported.
Gastrointestinal disorders Abdominal pain	2.0% 1/51 • Number of events 1 • 34 months Only serious adverse events are reported.
Vascular disorders Intra-abdominal haematoma	2.0% 1/51 • Number of events 1 • 34 months Only serious adverse events are reported.

Other adverse events

Adverse event data not reported

Additional Information

Alfonso Piciocchi

GIMEMA

Phone: +39 06 70390513

Email: a.piciocchi@gimema.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place