Clinical Outcomes of 3L+ Therapies Among Patients With Chronic Myeloid Leukemia and Those With T315I Mutation

Last updated: April 5, 2023
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

N/A

Condition

Leukemia

Chronic Myeloid Leukemia

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT05611216
CABL001AUS09
  • Ages > 18
  • All Genders

Study Summary

The study was a retrospective, non-interventional patient chart review and used a panel of oncologists/hematologists from the US to collect real-world clinical outcomes of patients with CML-CP in 3L+ and those with the T315I mutation.

Eligibility Criteria

Inclusion

Inclusion Criteria: Physician selection Physicians were eligible to participate in the study if they fulfilled all of the followingcriteria:

  • Completed medical subspecialty training
  • Reported hematology, medical oncology, or any other oncology subspecialties as theprimary medical subspecialty
  • Were responsible for treatment decisions and follow-up for ≥ 1 adult patient with Ph+CML-CP who received a 3L or those with the T315I mutation since January 2013 (the datefrom which molecular monitoring response on the International Scale (IS) became a morestandard procedure/commonly available
  • Had access to molecular monitoring results reported on the IS, and with a sensitivitylevel of precision for molecular response of MR3 (BCR ABL1/ABL1 ≤ 0.1% or 3-logreduction) or better Patient selection Participating physicians were directed to provide information on patientswho were included into the following separate cohorts. Each participating physiciancontributed up to 5 patient medical charts from each cohort. For the 3L cohort:
  • Adult patients diagnosed with Ph+ CML-CP who initiated a 1L therapy, switched to a 2Ltherapy, and initiated a 3L therapy for CML-CP
  • All lines of therapy (TKIs or other CML treatments) received outside of aninterventional clinical trial setting
  • 3L therapy was initiated on or after January 1st, 2013 (when molecular monitoringbecame a common practice in CML monitoring) and no later than November 30th, 2018, tohave a minimum of 2 years of follow-up after therapy initiation, except if the patientdied before For the T315I cohort:
  • Adult patients diagnosed with Ph+ CML-CP who initiated ≥ 1 line of therapy for Ph+CML-CP and T315I mutation was identified
  • All lines of therapy (TKIs or other CML treatments) received outside of aninterventional clinical trial setting
  • Line of therapy identified as the T315I line of interest was initiated on or afterJanuary 1st, 2013, and no later than November 30th, 2018, to have a minimum of 2 yearsof follow-up after therapy initiation, except if the patient died before For both cohorts:
  • Patients with Ph+ CML-CP for whom the physician had complete information on the CMLrelated care from CML diagnosis and for ≥ 2 years after the initiation of line oftherapy of interest (i.e., 3L or line of therapy identified as the T315I line ofinterest), unless the patient died before. Complete information included: CMLtreatments, treatment duration, routine laboratory (e.g., complete blood count (CBC),BCR-ABL), CML status (e.g., SOKAL risk score, CP/accelerated phase (AP)/ blast crisis (BC)), medications, and clinical status (e.g., history, physical exam)
  • The physician had access to molecular monitoring results reported on the IS frominitiation of the line of therapy of interest and with a sensitivity level ofprecision for molecular response of MR3 (BCR-ABL1/ABL1≤0.1% or 3-log reduction) orbetter Of note, the cohorts were not mutually exclusive such that patients included inthe 3L cohort with T315I mutation was included in the T315I cohort. Thereafter, therewas an oversampling of patients with T315I mutation. Patients from the T315I cohortfrom the oversampling with a 3L were not included in the 3L cohort.

Exclusion

Exclusion Criteria:

  • Physicians and patients who did not meet study inclusion criteria detailed above wereexcluded.

Study Design

Total Participants: 164
Study Start date:
December 01, 2020
Estimated Completion Date:
December 23, 2021

Study Description

This study included two distinct cohorts of CML-CP patients; that is, patients with CML-CP who initiated 3L for CML-CP (i.e., 3L cohort) and patients with CML-CP with T315I mutation (i.e., T315I cohort).

Study design for the analyses of the 3L cohort:

  • The index date: date of initiation of 3L therapy for CML-CP

  • The study period: period of ≥ 24 months following the index date unless the patient died before

  • Patient characteristics were measured at CML diagnosis and at the index date

  • The clinical outcomes of interest were measured during the study period

Study design for the analyses of the T315I cohort:

  • The index date: date of initiation of a line of therapy identified as the T315I line of interest (i.e., identification of T315I mutation before initiation or over the course of line of therapy)

  • The study period: period of ≥ 24 months following the index date unless the patient died before

  • Patient characteristics were measured at CML diagnosis and at the index date.

  • The clinical outcomes of interest were measured during the study period

Connect with a study center

  • Novartis Investigative Site

    East Hanover, New Jersey 07936
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.