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

Phase 2

Completed

• Conditions: Leukemia

• Registration Number: NCT00458848
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2007-04-09
• Study First Submitted QC: 2007-04-09
• Study First Posted: 2007-04-11
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2017-11-21
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-24
• Last Update Submitted: 2018-09-24
• Results First Posted: 2019-02-15
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Reaching Disease Free Survival	At 60 months

Secondary Outcome Measures

Name	Time	Method
Number of Patients Reaching Complete Hematological Response After Induction Therapy	At the end of induction, day +50
Percentage of Participants Reaching Overall Survival	At 60 months	Overall survival from diagnosis

Trial Locations

Locations (66)

Ospedale Civile Alessandria; 🇮🇹 Alessandria, Italy

Ospedale Torrette University Ancona; 🇮🇹 Ancona, Italy

Ospedale S. Donato; 🇮🇹 Arezzo, Italy

Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"; 🇮🇹 Ascoli Piceno, Italy

S.G. Moscati Hospital; 🇮🇹 Avellino, Italy

Universita Degli Studi di Bari; 🇮🇹 Bari, Italy

University of Bologna Medical School; 🇮🇹 Bologna, Italy

Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

A. Perrino Hospital; 🇮🇹 Brindisi, Italy

Ospedale Binaghi; 🇮🇹 Cagliari, Italy

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