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

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ClinicalTrials.gov Identifier: NCT01025505
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
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Tracking Information
First Submitted Date  ICMJE December 1, 2009
First Posted Date  ICMJE December 3, 2009
Last Update Posted Date October 15, 2018
Actual Study Start Date  ICMJE June 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
Disease-Free Survival (DFS) [ Time Frame: at 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
  • 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)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ph+/Bcr-Abl+ ALL Imatinib and Nilotinib Rotational Study
Official Title  ICMJE 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
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 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Treatment
  • Stem Cell Transplantation
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 2, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01025505
Other Study ID Numbers  ICMJE LAL1408
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gruppo Italiano Malattie EMatologiche dell'Adulto
Study Sponsor  ICMJE Gruppo Italiano Malattie EMatologiche dell'Adulto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michele Baccarani Policlinico Sant'Orsola
PRS Account Gruppo Italiano Malattie EMatologiche dell'Adulto
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP