LAL1408: Ph+/Bcr-Abl+ ALL Imatinib and Nilotinib Rotational Study

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)

Overall Status

Unknown status

CT.gov ID

NCT01025505

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

1.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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 Design

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2012

Actual Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2018

Outcome Measures

Primary Outcome Measures

Disease-Free Survival (DFS) [at 24 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Azienda Ospedaliera - Nuovo Ospedale "Torrette"	Ancona	Italy
2	Dipartimento Area Medica P.O.	Ascoli Piceno	Italy	63100
3	UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari	Bari	Italy
4	Ospedali Riuniti	Bergamo	Italy
5	Ist.Ematologia e Oncologia Medica L.e A. Seragnoli	Bologna	Italy
6	Sezione di Ematologia e Trapianti Spedali Civili	Brescia	Italy	21125
7	Osp. Reg. A. Di Summa	Brindisi	Italy
8	Servizio di Ematologia - CTMO - ASL 8 P.O. Binaghi	Cagliari	Italy
9	Ospedale Ferrarotto	Catania	Italy	95124
10	Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna	Ferrara	Italy	44100
11	Clinica Ematologica - Università degli Studi	Genova	Italy
12	Ospedale Niguarda "Ca' Granda"	Milano	Italy	20122
13	Sez. di medicina Interna Oncologia ed Ematologia	Modena	Italy
14	Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia	Napoli	Italy
15	Ospedale di Rilievo Nazionale "A. Cardarelli"	Napoli	Italy
16	S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro	Novara	Italy
17	Ospedale S. Luigi Gonzaga	Orbassano	Italy	10043
18	Università degli Studi di Padova - Ematologia ed Immunologia Clinica	Padova	Italy
19	Ospedali Riuniti 'Villa Sofia-Cervello'	Palermo	Italy
20	Div. di Ematologia IRCCS Policlinico S. Matteo	Pavia	Italy	27100
21	Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore	Pesaro	Italy
22	U.O. Ematologia Clinica - Azienda USL di Pescara	Pescara	Italy	65100
23	Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza	Piacenza	Italy
24	Ospedale S.Maria delle Croci	Ravenna	Italy	48100
25	Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"	Reggio Calabria	Italy
26	Rimini Ospedale "Infermi"	Rimini	Italy
27	Complesso Ospedaliero S. Giovanni Addolorata	Roma	Italy	00184
28	Università degli Studi - Policlinico di Tor Vergata	Roma	Italy	21100
29	U.O.C. Ematologia - Ospedale S.Eugenio	Roma	Italy
30	Università Cattolica del Sacro Cuore - Policlinico A. Gemelli	Roma	Italy
31	Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia	Roma	Italy
32	U.O. Ematologia, Azienda Ospedaliera Universitaria Senese	Siena	Italy	53100
33	SCDO Ematologia 2 AOU S.Giovanni Battista	Torino	Italy
34	Policlinico Universitario - Clinica Ematologia	Udine	Italy	33100
35	Policlinico G.B. Rossi	Verona	Italy	37134

Sponsors and Collaborators

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

Principal Investigator: Michele Baccarani, Policlinico Sant'Orsola

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

GIMEMA Foundation website

Publications

None provided.

Responsible Party:

Gruppo Italiano Malattie EMatologiche dell'Adulto

ClinicalTrials.gov Identifier:

NCT01025505

Other Study ID Numbers:

LAL1408

First Posted:

Dec 3, 2009

Last Update Posted:

Oct 15, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto

Untreated Ph+ ALL unfit for intense therapy and allo SCT

Additional relevant MeSH terms:

Imatinib Mesylate

Study Results

No Results Posted as of Oct 15, 2018