STI 571 (GLIVEC) in the Treatment of Adult Acute Lymphoblastic Leukemia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by:
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00376467
First received: September 13, 2006
Last updated: November 24, 2010
Last verified: November 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Acute Lymphoblastic Leukemia |
Drug: Imatinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Primary Outcome Measures:
- for Study A, the primary endpoint for activity is overall CMR rate [ Time Frame: after 6 months of imatinib treatment ] [ Designated as safety issue: No ]
- for Study B, the primary endpoint for activity is overall CHR (+/- CMR) rate . [ Time Frame: after induction treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- complete hematological or molecular remission duration [ Time Frame: at study end ] [ Designated as safety issue: No ]
- overall survival. [ Time Frame: at study end ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 91 |
| Study Start Date: | December 2001 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00376467
Contacts
| Contact: Marco Vignetti, MD | +39 06 441639 831 | vignetti@bce.uniroma1.it |
| Contact: Paola Fazi, MD | +39 06 441639 830 | fazi@bce.uniroma1.it |
Locations
| Italy | |
| Divisione di Ematologia, Azienda Policlinico "Umberto I", Università degli Studi "La Sapienza" | Recruiting |
| Rome, Italy, 00161 | |
| Contact: Giovanna Meloni, PhD +39 06 857 95 741 meloni@bce.uniroma1.it | |
| Contact: Antonella Vitale, MD +39 06 857 951 vitale@bce.uniroma1.it | |
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
| Principal Investigator: | Michele Baccarani | Università degli Studi di Udine |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00376467 History of Changes |
| Other Study ID Numbers: | LAL0201 |
| Study First Received: | September 13, 2006 |
| Last Updated: | November 24, 2010 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
|
Acute Lymphoblastic Leukemia Philadelphia positive Adult Elderly Imatinib |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Philadelphia Chromosome Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Translocation, Genetic Chromosome Aberrations Pathologic Processes Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013