STI 571 (GLIVEC) in the Treatment of Adult Acute Lymphoblastic Leukemia
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ClinicalTrials.gov Identifier: NCT00376467 |
Recruitment Status :
Completed
First Posted : September 14, 2006
Last Update Posted : February 7, 2014
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This proposal, developed in the framework of the GIMEMA, will permit:
- to evaluate the activity and toxicity of imatinib in the treatment of Ph+ acute lymphoblastic leukemia;
- to evaluate the molecular response to the treatment, and to monitor the molecular status of remission in all cases achieving or not a molecular response.
The GIMEMA has activated a network to centralize all biological samples (bone marrow and peripheral blood) at diagnosis from all new ALL patients. This will permit to identify, in particular, Ph + and/or BCR/ABL + cases within 5 days from diagnosis, thus permitting to treat these patients according to different programs on the basis of the presence of Ph chromosome.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Lymphoblastic Leukemia | Drug: Imatinib | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 105 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | STI 571 (GLIVEC) in the Treatment of Philadelphia-chromosome Positive and/or BCR/ABL Rearranged Adult Acute Lymphoblastic Leukemia. GIMEMA LAL 0201. |
Study Start Date : | December 2001 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | February 2011 |

- for Study A, the primary endpoint for activity is overall CMR rate [ Time Frame: after 6 months of imatinib treatment ]
- for Study B, the primary endpoint for activity is overall CHR (+/- CMR) rate . [ Time Frame: after induction treatment ]
- complete hematological or molecular remission duration [ Time Frame: at study end ]
- overall survival. [ Time Frame: at study end ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with Ph +ve and/or BCR/ABL +ve ALL, either in 1st CHR (independently from the molecular status) for study A, or at diagnosis and untreated for study B;
- Age >18 years and <60 for study A, >60 for study B;
- Written voluntary informed consent.
Exclusion Criteria:
- Patients of childbearing potential without a negative pregnancy test prior to the initiation of study. Barrier contraceptive precautions are to be used throughout the trial in both sexes;
- Pretreatment with steroids for more than 10 days in study B;
- Serum bilirubin and creatinine values >3 the upper limit of normal range;
- SGOT and SGPT values >3 the upper limit of the normal range;
- Patients who had received any other investigational agent within 4 weeks before the enrollment;
- Patients with cardiovascular diseases grade >3 according to the New York Heart Association (see Appendix 1);
- Patients with a history of non compliance to medical regimen or who are considered potentially unreliable;
- Patients with moderate/severe mood or psychiatric disorders;
- Concomitant neoplasia.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376467

Principal Investigator: | Michele Baccarani | Università degli Studi di Udine |
Responsible Party: | Gruppo Italiano Malattie EMatologiche dell'Adulto |
ClinicalTrials.gov Identifier: | NCT00376467 |
Other Study ID Numbers: |
LAL0201 |
First Posted: | September 14, 2006 Key Record Dates |
Last Update Posted: | February 7, 2014 |
Last Verified: | February 2014 |
Acute Lymphoblastic Leukemia Philadelphia positive Adult Elderly Imatinib |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |