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Optimization of TKIs Treatment and Quality of Life in Ph+ CML Patients ≥60 Years in Deep Molecular Response

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ClinicalTrials.gov Identifier: NCT02326311
Recruitment Status : Recruiting
First Posted : December 29, 2014
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
Prof Domenico Russo, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brief Summary:
In this phase III clinical randomized study, "fixed" intermittent administration (one month ON/one month OFF) of TKIs (control arm), will be compared with "progressive" intermittent administration (one month ON/one month OFF for the 1st year; one month ON/two months OFF for the 2nd year; one month ON/three months OFF for the 3rd year) (experimental arm). Imatinib (Glivec), or Nilotinib (Tasigna), or Dasatinib (Sprycel) will be given intermittently at the same daily dose that was given daily at the time of the enrollment . Chronic phase Ph+ CML patients in stable major molecular response (MR3.0 or MR4.0) after ≥2 years of standard treatment with IM, NIL, or DAS will be randomized 1:1 to receive "fixed" INTERIM or "progressive" INTERIM. Randomization will be stratified by type of TKI (IM, NIL, or DAS,) and by depth of molecular response (MR3.0or MR4.0). The study is aimed to evaluate if a progressive increase of intermittent treatment discontinuation until 3 months is able to improve QoL outcomes with respect to "fixed" intermittent administration of TKIs (control arm) and to maintain MR3.0 / MR4.0 molecular response. Patients' self reported EORTC QLQ-C30 outcome measure will be assessed throughout the three years follow up period. The QoL results in this trial will be presented in accordance with high methodological quality criteria for documenting patient-reported outcomes (PRO) data in RCTs, including the CONSORT PRO recommendations. Furthermore, the study could give additional clinical and biological information to optimize TKIs therapy in elderly.

Condition or disease Intervention/treatment Phase
Leukemia, Chronic Myeloid Drug: imatinib Drug: nilotinib Drug: dasatinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 502 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase-III Randomized Study to Optimize TKIs Multiple Approaches - (OPTkIMA) - and Quality of Life (QoL) in Elderly Patients (≥60 Years) With Ph+ Chronic Myeloid Leukemia (CML) and MR3.0 / MR4.0 Stable Molecular Response
Actual Study Start Date : June 10, 2015
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Active Comparator: Fixed INTERIM TKI
Intervention: "fixed" intermittent administration (one month ON/one month OFF) of TKIs (imatinib, nilotinib, dasatinib)
Drug: imatinib
Tyrosin kinase inhibitor
Other Name: Glivec

Drug: nilotinib
Tyrosin kinase inhibitor
Other Name: Tasigna

Drug: dasatinib
Tyrosin kinase inhibitor
Other Name: Sprycell

Experimental: Progressive INTERIM TKI
Intervention: "progressive" intermittent administration (one month ON/one month OFF for the 1st year; one month ON/two months OFF for the 2nd year; one month ON/three months OFF for the 3rd year) (imatinib, nilotinib, dasatinib)
Drug: imatinib
Tyrosin kinase inhibitor
Other Name: Glivec

Drug: nilotinib
Tyrosin kinase inhibitor
Other Name: Tasigna

Drug: dasatinib
Tyrosin kinase inhibitor
Other Name: Sprycell




Primary Outcome Measures :
  1. Change in quality of Life [ Time Frame: Baseline (T0), and then at 3 (T1), 6 (T2), 9 (T3), 12 (T4), 18 (T5), 24 (T6), 30 (T7), and 36 (T8) months ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a confirmed diagnosis of Ph+ CML in CP
  2. Age ≥ 60 years old
  3. Stable MR3.0/ MR4.0 after at least 2 years of treatment with standard (daily administration) IM, NIL, or DAS therapy; the stability of molecular response will be documented by at least 3 consecutive molecular analyses over the last 12 months.
  4. Having completed the QoL baseline evaluation (i.e., before randomization)
  5. Written informed consent prior to any study procedures

Exclusion Criteria:

  1. Patients with Ph+ CML in accelerated/blastic phase (AP/BP), or in late CP previously treated (i.e. IFNalpha+/- low dose Ara-C, Hydroxurea, allogeneic stem cell transplantation, etc)
  2. Age < 60 years old
  3. Less than 2 years of treatment with standard (continuous administration) IM, NIL or DAS therapy

3. Absence of stable MR3.0/MR4.0 as documented by at least 3 consecutive molecular analyses over the last 12 months 4. No written informed consent prior to any study procedures. 5. Having any kind of psychiatric disorder or major cognitive dysfunction hampering a QoL evaluation (as judged by the physician).


Information from the National Library of Medicine

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): NCT02326311


Contacts
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Contact: Domenico Russo, Professor +390303996810 domenico.russo@unibs.it
Contact: Michele Malagola, MD +390303996810 michelemalagola@yahoo.it

Locations
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Italy
Policlinico Universitario di Milano Recruiting
Milano, Italy
Contact: Alessandra Iurlo, MD         
Sponsors and Collaborators
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Investigators
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Principal Investigator: Domenico Russo, Professor Chair of Hematology, BMT Unit
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Responsible Party: Prof Domenico Russo, Full Professor of Hematology, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT02326311    
Other Study ID Numbers: AOBSTMO-OPTKIMA-2014
First Posted: December 29, 2014    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action