De Novo Adult Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients (LAL1509)
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|ClinicalTrials.gov Identifier: NCT01361438|
Recruitment Status : Active, not recruiting
First Posted : May 26, 2011
Last Update Posted : February 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|ALL Ph Positive||Other: Total therapy approach||Phase 2|
This study will enroll adult de novo Ph+ acute lymphoblastic leukemia (ALL) patients (≥18 years, ≤60 years). Induction treatment will consist of 12 weeks of Dasatinib oral administration (140 mg QD). Patients will initiate treatment with steroids 7 days prior to starting Dasatinib and will continue up to day 31. Patients will continue treatment with Dasatinib up to day 84, except for disease progression, intolerable toxicity, or withdrawal from study.
- patients in hematological and molecular CR will receive a post-remissional treatment consisting of Dasatinib alone for a 6 months period
- patients in hematological CR with persistence of molecular disease will be allografted or, if not eligible or a donor is not available, treated with 2 cycles of a Clofarabine-Cyclophosphamide schedule.
- MRD negative patients (i.e. in CHR and PCR negative) will receive a 6 months Dasatinib maintenance treatment;
- MRD positive patients (i.e. in CHR and PCR positive) will receive Dasatinib as maintenance treatment until relapse or progression.
Patients not transplanted and treated with Clofarabine/Cyclophosphamide will also receive Dasatinib as maintenance treatment until relapse or progression.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Total Therapy Strategy for De Novo Adult Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients. GIMEMA Protocol LAL1509, EudraCT Number 2010-019119-39|
|Actual Study Start Date :||June 2011|
|Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||March 2018|
Other: Total therapy approach
- The primary objective of the trial is to estimate the feasibility of a total therapy strategy in de novo adult Ph positive ALL. [ Time Frame: at 42 months ]The primary endpoint is the rate of patients alive in CHR who have completed the trial treatment according to the therapeutic strategy;
- The median value of the minimum of PCR levels achieved in each patient during the Dasatinib treatment within day +85, whenever achieved from the start of the Dasatinib. [ Time Frame: at 42 months ]
- The rate of patients who become PCR negative after Dasatinib induction. [ Time Frame: at 42 months ]
- Out of patients who become PCR negative after induction, the rate of patients who remain persistently negative during maintenance treatment with Dasatinib (without chemotherapy or allogeneic transplant). [ Time Frame: at 42 months ]
- The median value of the minimum of PCR levels achieved in each patient after an allogeneic transplant or Clofarabine-Cyclophosphamide treatment as consolidation therapy. [ Time Frame: at 42 months ]
- The rate of patients alive in CHR who have completed the maintenance program with Dasatinib after an allogeneic transplant or two cycles of Clofarabine-Cyclophosphamide as consolidation therapy. [ Time Frame: at 42 months ]
- Disease free survival estimation starting from the date of evaluation of CHR. [ Time Frame: at 42 months ]
- Cumulative incidence of relapse estimation starting from the date of evaluation of CHR. [ Time Frame: at 42 months ]
- Overall survival estimation starting from date of inclusion. [ Time Frame: at 42 months ]
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): NCT01361438
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|Study Chair:||Roberto Foà, Pr.||Università Sapienza di Roma|