TreatmentPhase 2LAL1408NCT01025505
Ph+/Bcr-Abl+ ALL Imatinib and Nilotinib Rotational Study
A Phase 2 study testing Nilotinib and Imatinib in people with Treatment and Stem Cell Transplantation, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 35 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment, Stem Cell Transplantation
- What is being tested?
- Nilotinib and Imatinib
- How many people
- 40 participants
- Where
- 35 sitesItaly
- Study dates
- Jun 2012to 1 Sep 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Italy35 sites
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona
Dipartimento Area Medica P.O.
Ascoli Piceno, 63100
UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
Bari
Ospedali Riuniti
Bergamo
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
Bologna
Sezione di Ematologia e Trapianti Spedali Civili
Brescia, 21125
Osp. Reg. A. Di Summa
Brindisi
Servizio di Ematologia - CTMO - ASL 8 P.O. Binaghi
Cagliari
Ospedale Ferrarotto
Catania, 95124
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
Ferrara, 44100
Clinica Ematologica - Università degli Studi
Genova
Ospedale Niguarda "Ca' Granda"
Milan, 20122
Sez. di medicina Interna Oncologia ed Ematologia
Modena
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Naples
Ospedale di Rilievo Nazionale "A. Cardarelli"
Naples
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara
Ospedale S. Luigi Gonzaga
Orbassano, 10043
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
Padova
Ospedali Riuniti 'Villa Sofia-Cervello'
Palermo
Div. di Ematologia IRCCS Policlinico S. Matteo
Pavia, 27100
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
Pesaro
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, 65100
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
Piacenza
Ospedale S.Maria delle Croci
Ravenna, 48100
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria
Rimini Ospedale "Infermi"
Rimini
Complesso Ospedaliero S. Giovanni Addolorata
Roma, 00184
Università degli Studi - Policlinico di Tor Vergata
Roma, 21100
U.O.C. Ematologia - Ospedale S.Eugenio
Roma
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
Siena, 53100
SCDO Ematologia 2 AOU S.Giovanni Battista
Torino
Policlinico Universitario - Clinica Ematologia
Udine, 33100
Policlinico G.B. Rossi
Verona, 37134
About this study
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
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.
- Conditions
- Treatment, Stem Cell Transplantation
- Being tested
- Nilotinib, Imatinib
- Keywords
- Untreated Ph+ ALL unfit for intense therapy and allo SCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NilotinibDrug
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.
ImatinibDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS)
Measured: at 24 months
Secondary outcomes (7)
Complete Hematological Response (CHR) rate
Measured: at 6, 12 and 24 weeks
Complete Cytogenetic Response (CCgR) rate
Measured: at 6, 12 and 24 weeks and duration of CCgR
Complete molecular response rate (CMR)
Measured: at 12 and 24 weeks and duration of CMolR
Type and number of BCR-ABL kinase domain mutations
Measured: developing during and after the study
Relationship between the response, biomarkers and gene expression profile (GEP)
Measured: At the end of study
Event-Free Survival (EFS) and Overall Survival (OS)
Measured: defined as the time from the 1st dose of corticosteroids to death or last contact
Side effects, adverse events (AE) and serious AE (SAE)
Measured: At the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startJun 2012
- Primary completionDec 2015
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele Baccarani, Principal investigator, Policlinico Sant'Orsola
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025505
- Sponsor's protocol ID
- LAL1408
- Acronym
- LAL1408
- Status last verified
- Oct 2022
- First submitted
- 1 Dec 2009
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01025505
- Acronym / sponsor ID
- LAL1408 / LAL1408
- Conditions
- Treatment, Stem Cell Transplantation
- Keywords
- Untreated Ph+ ALL unfit for intense therapy and allo SCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 3 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NilotinibThe 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 | – |
| ImatinibThe 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. | Drug | – |
Primary outcome
Disease-Free Survival (DFS)
Time frame: at 24 months
7 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- GIMEMA Foundation websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Baccarani principal investigator
Policlinico Sant'Orsola
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nilotinib and Imatinib in people with Treatment and Stem Cell Transplantation, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 35 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) (time frame: at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.