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

NCT05611216 | Completed

• 1 other identifier: CABL001AUS09
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Myeloid Leukemia

Keywords

CML,; CP,; case report from,; lines of therapy,; T315I mutation

Outcome Measures

Primary Outcomes (11)

• Number of lines of therapy

  To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy

  throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)

• Number of patients with total number of lines

  To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy

  throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)

• Number of patients: Treatment received

  To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy

  throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)

• Number of patients: Calendar year of line of therapy initiation

  To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy

  throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)

• Duration of line of therapy

  To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy

  throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)

• Number of patients with most frequent treatment sequences from first- to third-line of therapy

  To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy

  throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)

• Number of patients who died after initiation of third-line therapy

  To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy

  throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)

• Number of patients who progressed to AP/BC after initiation of third-line therapy

  To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy

  throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)

• Number of patients who underwent HSCT after initiation of third-line therapy

  To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy

  throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)

• Number of patients developed graft versus host disease after undergoing HSCT3

  To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy

  throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)

• Number of patients who were still on the third-line therapy as of the data collection date

  To evaluate treatment patterns in patients with CML-CP who were previously treated with TKI or other CML treatments and were relapsed/refractory to/were intolerant/had other reasons for switching of CML therapy

  throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)

Secondary Outcomes (20)

• Number of patients who achieved molecular response during third-line therapy

  throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)

• Number of patients who achieved cytogenic response during third-line therapy

  throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)

• Number of patients who achieved complete hematologic response during third-line therapy

  throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)

• Number of patients who achieved molecular response during the line of therapy identified as the T315I line of interest

  throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)

• Number of patients who achieved cytogenic response during the line of therapy identified as the T315I line of interest

  throughout the study period, approximately 5 years (On or after January 1st, 2013 and no later than November 30th, 2018)

Study Arms (2)

Third-line (3L) Cohort

patients with Chronic Myeloid Leukemia - Chronic Phase (CML-CP) who initiated 3L for CML-CP

T315I Cohort

patients with CML-CP with T315I mutation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Chronic Myeloid Leukemia and those with T315I Mutation in the United States

You may qualify if:

• Physician selection
• Physicians were eligible to participate in the study if they fulfilled all of the following criteria:
• Completed medical subspecialty training
• Reported hematology, medical oncology, or any other oncology subspecialties as the primary 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 date from which molecular monitoring response on the International Scale (IS) became a more standard procedure/commonly available
• Had access to molecular monitoring results reported on the IS, and with a sensitivity level of precision for molecular response of MR3 (BCR ABL1/ABL1 ≤ 0.1% or 3-log reduction) or better
• Patient selection Participating physicians were directed to provide information on patients who were included into the following separate cohorts. Each participating physician contributed 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 2L therapy, and initiated a 3L therapy for CML-CP
• All lines of therapy (TKIs or other CML treatments) received outside of an interventional clinical trial setting
• L therapy was initiated on or after January 1st, 2013 (when molecular monitoring became a common practice in CML monitoring) and no later than November 30th, 2018, to have a minimum of 2 years of follow-up after therapy initiation, except if the patient died 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 an interventional clinical trial setting
• Line of therapy identified as the T315I line of interest was initiated on or after January 1st, 2013, and no later than November 30th, 2018, to have a minimum of 2 years of follow-up after therapy initiation, except if the patient died before

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936, United States

Location

Related Links

• Results for CABL001AUS09 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 9, 2022
• Study Start: December 1, 2020
• Primary Completion: December 23, 2021
• Study Completion: December 23, 2021
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)