Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia

NCT06629584 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2024-0396NCI-2024-07923
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, phase 2 study investigating asciminib in patients previously treated with one line of TKI therapy.

Conditions

Malignant Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Major molecular response (MMR) rate by 12 months

  MMR rate at 12 months with the 95% confidence interval will also be estimated.

  at 12 months of therapy

Study Arms (1)

Asciminib

EXPERIMENTAL

Patients will receive asciminib 80 mg once daily continuously for 28-day cycles for 2 years.

Drug: Asciminib

Interventions

Asciminib DRUG

Patients will receive asciminib 80 mg PO once daily continuously for 28-day cycles for 2 years.

Asciminib

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Diagnosis of Ph-positive (by cytogenetics or FISH) or BCR-ABL-positive (by PCR) CML in chronic phase and have received one prior line of therapy with a TKI.
• History of treatment failure defined as either:
• BCR::ABL1 \>0.1% for patients with intolerance to first-line TKI
• Less than complete hematologic response (CHR) at ≥3 months
• No partial cytogenetic response at ≥3 months
• BCR::ABL1 ≥ 10% at if 3-6 months
• BCR::ABL1 ≥ 1% at ≥6 months
• Loss of CCyR or development of mutations or other clonal chromosomal abnormalities at any time during TKI treatment
• ECOG performance status ≤ 2.
• Adequate end organ function within 12 days before the first dose of asciminib treatment. Patients with mild to moderate renal and hepatic impairment are eligible if:
• Total bilirubin ≤ 3.0 x ULN without AST/ALT increase
• Aspartate transaminase (AST) ≤ 5.0 x ULN
• Alanine transaminase (ALT) ≤ 5.0 x ULN
• Serum lipase ≤ 1.5 x ULN. For serum lipase \> ULN and ≤ 1.5 x ULN, value should be considered not clinically significant and not associated with risk factors for acute pancreatitis

You may not qualify if:

• Patients with a history of T315I mutation.
• Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF \< 40% by echocardiogram or multi-gated acquisition (MUGA) scan.
• Patients with a history of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third-degree AV block).
• Corrected QT interval (QTc) of \> 450 milliseconds (ms) on baseline electrocardiogram (ECG or EKG) (using the Fridericia Formula)
• Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
• Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
• Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointes that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication.
• Patients with known active infection with human immunodeficiency virus (HIV) or Hepatitis B or C.
• Patients with known conditions that would significantly affect the ingestion or gastrointestinal absorption of drugs administered orally.
• History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.
• ANC \< 500/mm3, platelet count \< 50,000 mm3.
• History of other active malignancy within 2 years prior to study entry except for previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively.
• Subject has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study.
• Patients should have discontinued therapy with imatinib, bosutinib, dasatinib or nilotinib or other anti-leukemia therapy (except hydroxyurea), at least 48 hours prior to start of study therapy and recovered from any toxicity due to these therapies to at least grade 1. The use of hydroxyurea is allowed immediately prior to study entry.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Novartis: collaborator

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Interventions

asciminib

Study Officials

• Ghayas Issa, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghayas Issa, MD

CONTACT

(713) 745-6798; gcissa@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 8, 2024
• Study Start: February 14, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)