Ph+/Bcr-Abl+ ALL Imatinib and Nilotinib Rotational Study (LAL1408)
This study is ongoing, but not recruiting participants.
Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01025505
First received: December 1, 2009
Last updated: January 27, 2015
Last verified: January 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Treatment Stem Cell Transplantation |
Drug: Nilotinib Drug: Imatinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Acute Lymphoblastic Leukemia
Acute Monoblastic Leukemia
Acute Myeloblastic Leukemia Type 5
U.S. FDA Resources
Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Primary Outcome Measures:
- Disease-Free Survival (DFS) [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Complete Hematological Response (CHR) rate [ Time Frame: at 6, 12 and 24 weeks ] [ Designated as safety issue: No ]
- Complete Cytogenetic Response (CCgR) rate [ Time Frame: at 6, 12 and 24 weeks and duration of CCgR ] [ Designated as safety issue: No ]
- Complete molecular response rate (CMR) [ Time Frame: at 12 and 24 weeks and duration of CMolR ] [ Designated as safety issue: No ]
- Type and number of BCR-ABL kinase domain mutations [ Time Frame: developing during and after the study ] [ Designated as safety issue: No ]
- Relationship between the response, biomarkers and gene expression profile (GEP) [ Time Frame: At the end of study ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Side effects, adverse events (AE) and serious AE (SAE) [ Time Frame: At the end of study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | January 2018 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025505
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025505
Locations
| Italy | |
| Azienda Ospedaliera - Nuovo Ospedale "Torrette" | |
| Ancona, Italy | |
| Dipartimento Area Medica P.O. | |
| Ascoli Piceno, Italy, 63100 | |
| UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari | |
| Bari, Italy | |
| Ospedali Riuniti | |
| Bergamo, Italy | |
| Ist.Ematologia e Oncologia Medica L.e A. Seragnoli | |
| Bologna, Italy | |
| Sezione di Ematologia e Trapianti Spedali Civili | |
| Brescia, Italy, 21125 | |
| Osp. Reg. A. Di Summa | |
| Brindisi, Italy | |
| Servizio di Ematologia - CTMO - ASL 8 P.O. Binaghi | |
| Cagliari, Italy | |
| Ospedale Ferrarotto | |
| Catania, Italy, 95124 | |
| Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna | |
| Ferrara, Italy, 44100 | |
| Clinica Ematologica - Università degli Studi | |
| Genova, Italy | |
| Ospedale Niguarda "Ca' Granda" | |
| Milano, Italy, 20122 | |
| Sez. di medicina Interna Oncologia ed Ematologia | |
| Modena, Italy | |
| Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia | |
| Napoli, Italy | |
| Ospedale di Rilievo Nazionale "A. Cardarelli" | |
| Napoli, Italy | |
| S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro | |
| Novara, Italy | |
| Ospedale S. Luigi Gonzaga | |
| Orbassano, Italy, 10043 | |
| Università degli Studi di Padova - Ematologia ed Immunologia Clinica | |
| Padova, Italy | |
| Ospedali Riuniti 'Villa Sofia-Cervello' | |
| Palermo, Italy | |
| Div. di Ematologia IRCCS Policlinico S. Matteo | |
| Pavia, Italy, 27100 | |
| Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore | |
| Pesaro, Italy | |
| U.O. Ematologia Clinica - Azienda USL di Pescara | |
| Pescara, Italy, 65100 | |
| Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza | |
| Piacenza, Italy | |
| Ospedale S.Maria delle Croci | |
| Ravenna, Italy, 48100 | |
| Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli" | |
| Reggio Calabria, Italy | |
| Rimini Ospedale "Infermi" | |
| Rimini, Italy | |
| Università degli Studi - Policlinico di Tor Vergata | |
| Roma, Italy, 21100 | |
| Complesso Ospedaliero S. Giovanni Addolorata | |
| Roma, Italy, 00184 | |
| U.O.C. Ematologia - Ospedale S.Eugenio | |
| Roma, Italy | |
| Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia | |
| Roma, Italy | |
| Università Cattolica del Sacro Cuore - Policlinico A. Gemelli | |
| Roma, Italy | |
| U.O. Ematologia, Azienda Ospedaliera Universitaria Senese | |
| Siena, Italy, 53100 | |
| SCDO Ematologia 2 AOU S.Giovanni Battista | |
| Torino, Italy | |
| Policlinico Universitario - Clinica Ematologia | |
| Udine, Italy, 33100 | |
| Policlinico G.B. Rossi | |
| Verona, Italy, 37134 | |
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
| Principal Investigator: | Michele Baccarani | Policlinico Sant'Orsola |
More Information
No publications provided
| Responsible Party: | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| ClinicalTrials.gov Identifier: | NCT01025505 History of Changes |
| Other Study ID Numbers: | LAL1408 |
| Study First Received: | December 1, 2009 |
| Last Updated: | January 27, 2015 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
|
Untreated Ph+ ALL unfit for intense therapy and allo SCT |
Additional relevant MeSH terms:
|
Imatinib Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protein Kinase Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 02, 2015