search
Back to results

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

Primary Purpose

Leukemia, Chronic Myeloid

Status
Recruiting
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
imatinib
nilotinib
dasatinib
Sponsored by
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Chronic Myeloid

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Policlinico Universitario di MilanoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fixed INTERIM TKI

Progressive INTERIM TKI

Arm Description

Intervention: "fixed" intermittent administration (one month ON/one month OFF) of TKIs (imatinib, nilotinib, dasatinib)

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)

Outcomes

Primary Outcome Measures

Change in quality of Life

Secondary Outcome Measures

Full Information

First Posted
December 17, 2014
Last Updated
July 20, 2023
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
search

1. Study Identification

Unique Protocol Identification Number
NCT02326311
Brief Title
Optimization of TKIs Treatment and Quality of Life in Ph+ CML Patients ≥60 Years in Deep Molecular Response
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2015 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Chronic Myeloid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
502 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fixed INTERIM TKI
Arm Type
Active Comparator
Arm Description
Intervention: "fixed" intermittent administration (one month ON/one month OFF) of TKIs (imatinib, nilotinib, dasatinib)
Arm Title
Progressive INTERIM TKI
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
imatinib
Other Intervention Name(s)
Glivec
Intervention Description
Tyrosin kinase inhibitor
Intervention Type
Drug
Intervention Name(s)
nilotinib
Other Intervention Name(s)
Tasigna
Intervention Description
Tyrosin kinase inhibitor
Intervention Type
Drug
Intervention Name(s)
dasatinib
Other Intervention Name(s)
Sprycell
Intervention Description
Tyrosin kinase inhibitor
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a confirmed diagnosis of Ph+ CML in CP Age ≥ 60 years old 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. Having completed the QoL baseline evaluation (i.e., before randomization) Written informed consent prior to any study procedures Exclusion Criteria: 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) Age < 60 years old 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Domenico Russo, Professor
Phone
+390303996810
Email
domenico.russo@unibs.it
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Malagola, MD
Phone
+390303996810
Email
michelemalagola@yahoo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Domenico Russo, Professor
Organizational Affiliation
Chair of Hematology, BMT Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Universitario di Milano
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Iurlo, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs