Ph+/Bcr-Abl+ ALL Imatinib and Nilotinib Rotational Study (LAL1408)
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| ClinicalTrials.gov Identifier: NCT01025505 |
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Recruitment Status : Unknown
Verified October 2018 by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Recruitment status was: Active, not recruiting
First Posted : December 3, 2009
Last Update Posted : October 15, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Treatment Stem Cell Transplantation | Drug: Nilotinib Drug: Imatinib | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | June 2012 |
| Actual Primary Completion Date : | December 2015 |
| Estimated Study Completion Date : | December 2018 |
- Drug: Nilotinib
The dose of NIL is 800 mg daily (400 mg twice daily). It must be adapted according to specific guidelines in case of adverse events (AE). It cannot be increased.
- Drug: Imatinib
The dose of IM is 600 mg daily (300 mg b.i.d.). It must be adapted according to specific guidelines in case of AE. It cannot be increased.
- Disease-Free Survival (DFS) [ Time Frame: at 24 months ]
- 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 ]
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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:
- 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
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): NCT01025505
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| Principal Investigator: | Michele Baccarani | Policlinico Sant'Orsola |
| Responsible Party: | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| ClinicalTrials.gov Identifier: | NCT01025505 |
| Other Study ID Numbers: |
LAL1408 |
| First Posted: | December 3, 2009 Key Record Dates |
| Last Update Posted: | October 15, 2018 |
| Last Verified: | October 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Untreated Ph+ ALL unfit for intense therapy and allo SCT |
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Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |