A Real-world Chronic Myelogenous Leukemia (CML) Patient Disease Registry to Describe Patient Experience and Clinical Outcomes Among Patients With CML Receiving Approved First or Second Line Tyrosine Kinase Inhibitor (TKI) Therapy

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07091019
Status
Recruiting
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Conditions

  • Chronic Myelogenous Leukemia - Chronic Phase

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • TKIs — OTHER
    There is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.

Study Details

This CML disease registry (ASC4REAL-2) aims to gather evidence on the tolerability, safety, effectiveness, and patient-reported outcomes (PRO) in real-world healthcare from patients with Ph+-CML-CP treated with TKIs approved for 1L and 2L, including prospective follow-up for 5 years identifying and describing long-term treatment outcomes.

Key Dates

Start date
Dec 17, 2025
Status verified
Jun 2026
Primary completion
Apr 20, 2033
Completion
Apr 20, 2033

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Asciminib
    Patients who started their 1L or 2L asciminib following FDA approval on or after Oct-2024 OR Patients who have exited an asciminib interventional study in US for 1L/2L CML and are continuing treatment with asciminib in routine medical care
  • Arm: Bosutinib
    Patients who started 1L or 2L bosutinib on or after Oct-2021
  • Arm: Dasatinib
    Patients who started 1L or 2L dasatinib on or after Oct-2021
  • Arm: Imatinib
    Patients who started 1L or 2L imatinib on or after Oct-2021
  • Arm: Nilotinib
    Patients who started 1L or 2L nilotinib on or after Oct-2021

Primary Outcome Measure

Rate of discontinuation of index TKI due to AEs [ Time Frame: Up to 5 years ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-0271
+1 205 502 9967
Omer Jamy (PRINCIPAL_INVESTIGATOR)
Stockton Hematology Oncology Medical Group IncStocktonCalifornia95204
+1 209 466 2626
Ravleen Grewal (PRINCIPAL_INVESTIGATOR)
Lundquist Inst BioMed at HarborTorranceCalifornia90509-2910
Sarah Elizabeth Tomassetti (PRINCIPAL_INVESTIGATOR)
Stamford HospitalStamfordConnecticut06902
Joshua Dower (PRINCIPAL_INVESTIGATOR)
Sacred Heart Medical OncologyPensacolaFlorida32504
+1 850 416 2730
Dany El-Sayah (PRINCIPAL_INVESTIGATOR)
St Agnes HospitalBaltimoreMaryland21229
+1 410 368 3412
Carole Miller (PRINCIPAL_INVESTIGATOR)
NY Cancer and Blood SpecialistsEast SetauketNew York11733
Adam Hines (PRINCIPAL_INVESTIGATOR)
SUNY Upstate Medical UniversitySyracuseNew York13210
Gillian Kupakuwana-Suk (PRINCIPAL_INVESTIGATOR)
Tri-County Hematology and Oncology AssociatesCantonOhio44718
Norman Rafique (PRINCIPAL_INVESTIGATOR)
Oregon Oncology Specialists SalemSalemOregon97301
John Strother (PRINCIPAL_INVESTIGATOR)
Avera CancerSioux FallsSouth Dakota57105
+1 605 322 3064
Tiffani Kirkpatrick (PRINCIPAL_INVESTIGATOR)
Baylor Scott and White ResearchTempleTexas76502
+1 254 935 5838
Lucas Wong (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer Research CenterSeattleWashington98109-1024
+1 206 667 7315
Vivian Oehler (PRINCIPAL_INVESTIGATOR)
MultiCare Health System InstituteTacomaWashington98405
+1 253 403 5265
Nehal Masood (PRINCIPAL_INVESTIGATOR)
Northwest Medical SpecialtiesTacomaWashington98405
+1 253 428 8756
Ali Dadla (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALStockton Hematology Oncology Medical Group Inc· Stockton, CALundquist Inst BioMed at Harbor· Torrance, CAStamford Hospital· Stamford, CTSacred Heart Medical Oncology· Pensacola, FLSt Agnes Hospital· Baltimore, MD

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