This trial is active, not recruiting.

Conditions treatment, stem cell transplantation
Treatments nilotinib, imatinib
Phase phase 2
Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Start date June 2012
End date December 2015
Trial size 40 participants
Trial identifier NCT01025505, LAL1408


This study is an open-label, multicentric, exploratory, single arm, phase II study of adults who are either more than 60 years old, or are unfit for intensive chemotherapy and allo SCT. The patients are treated with NILOTINIB, administered orally twice daily, for 6 weeks (Course A) followed by IMATINIB, administered orally twice daily, for other 6 weeks (Course B).The courses will be repeated (rotated) for a total of 4 times or until relapse, or until it is in the interest of the patients. Prednisone (P) will be administered to all patients for 7-14 days, before TKIs, so as to make it possible to wait for the results of cytogenetic and molecular tests, and to evaluate the response to P alone, hence for another 21 days. Intrathecal therapy (IT) with MTX/AraC/DEX is mandatory, monthly, in patients without clinical-cytologic evidence of meningeal involvement, while in patients with CNS involvement it is performed twice weekly until clearance of leukemic cells, hence once weekly. IM will be administered at the dosage of 600 mg daily (300 mg twice daily) and Nilotinib at the dosage of 800 mg daily (400 mg twice daily) in all courses.

All patients are scheduled to receive at least 4 courses of either drugs, for a total of 4 courses (4 x 6 = 24 weeks). After 4 courses, patients are either allowed to continue the treatment until relapse or progression, if it is in their interest, or to discontinue the treatment and receive other therapies.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Disease-Free Survival (DFS)
time frame: at 24 months

Secondary Outcomes

Complete Hematological Response (CHR) rate
time frame: at 6, 12 and 24 weeks
Complete Cytogenetic Response (CCgR) rate
time frame: at 6, 12 and 24 weeks and duration of CCgR
Complete molecular response rate (CMR)
time frame: at 12 and 24 weeks and duration of CMolR
Type and number of BCR-ABL kinase domain mutations
time frame: developing during and after the study
Relationship between the response, biomarkers and gene expression profile (GEP)
time frame: At the end of study
Event-Free Survival (EFS) and Overall Survival (OS)
time frame: defined as the time from the 1st dose of corticosteroids to death or last contact
Side effects, adverse events (AE) and serious AE (SAE)
time frame: At the end of study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Previously untreated Ph+ ALL more than 60 years old or more than 18 years old, but unfit for program of intensive therapy and allogeneic SCT

Additional Information

Official title Front-line Treatment of Ph Positive (Ph+)/Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL) With Two Tyrosine Kinase Inhibitors (TKI) (Imatinib and Nilotinib). A Phase II Exploratory Multicentric Study in Elderly Patients and in Patients Unfit for Program of Intensive Therapy and Allogeneic Stem Cell Transplantation. GIMEMA Protocol LAL1408. EudraCT 2009-01327122
Principal investigator Michele Baccarani
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Gruppo Italiano Malattie EMatologiche dell'Adulto.