PEDIATRIC CML STUDY:

Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia
(Clinicaltrials.gov Identifier: NCT04925479)

This study aims to support the development of asciminib in pediatric patients (ages 1 to <18) previously treated with TKIs by extrapolating its efficacy from adult CML cases based on shared disease characteristics.

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USA: 8
China: 4
France: 4
Germany: 3
Greece: 1
Hungary: 1
Italy: 3
Japan: 3
Rep. of Korea: 2
Netherlands:1
Poland: 1
Russia: 2
Thailand: 3
Turkey: 2

Asciminib Roll-over Study
(Clinicaltrials.gov Identifier: NCT04877522)

This open-label, global roll-over study aims to assess the long-term safety of asciminib and provide continued treatment for patients who have completed a Novartis-sponsored asciminib study and are deemed to benefit from ongoing therapy.

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USA: 4
Argentina: 1
Austria: 2
Brazil: 3
Bulgaria: 1
Canada: 1
China: 12
Czechia: 2
Denmark: 1
France: 6
Germany: 4
Italy: 3
Japan: 1
Rep. Korea: 4
Lebanon: 1
Malaysia: 3
Mexico: 1
Poland: 4
Portugal: 2
Romania: 1
Russia: 4
Saudia Arabia: 1
Singapore: 1
Spain: 11
Taiwan: 1
Turkey: 1
UK: 2

Clinical Study of Asciminib in Previously Treated Indian Patients With Ph+ CML-CP Without T315I Mutation and in Patients With Ph+ CML-CP With T315I Mutation (ASC4INDIA)
(Clinicaltrials.gov Identifier: NCT06427811)

This Phase IV study aims to confirm the safety and efficacy of asciminib in Indian patients with Ph+ CML-CP, with and without the T315I mutation, following its approval by the Drugs Controller General of India.

Phase II Study Assessing Efficacy and Safety of Asciminib in Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

(Clinicaltrials.gov Identifier: NCT06236724)

The study aims to evaluate the effectiveness and safety of asciminib in controlling chronic myeloid leukemia (CML) by assessing molecular and cytogenetic responses, treatment-free remission, survival outcomes, and adverse events over time.

Recruiting
Estimated enrolment: 50 participants

Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase (ALERTCML)

(Clinicaltrials.gov Identifier: NCT05143840)

This Phase 2, multicenter, open-label study aims to evaluate the efficacy and safety of asciminib as a frontline treatment for newly diagnosed chronic-phase CML, with response monitored via PCR and an option to add a low-dose TKI if needed after 24-36 months.

Augusta University 

Contact details: 
jsonnenberg@augusta.edu

Asciminib Used in Consolidation With Imatinib vs. Imatinib to Achieve TFR in CP-CML
(Clinicaltrial.gov Identifier: NCT05413915)

The aim of this study is to establish if consolidation of imatinib-treated patients in stable DMR through the addition of asciminib, can lead to superior rates of TFR1, compared to imatinib alone in chronic phase-chronic myelogenous leukemia patients.

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Treatment Free Remission After Combination Therapy With Asciminib (ABL001) Plus Tyrosine Kinase Inhibitors (TKI) in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation
(Clinicaltrials.gov Identifier: NCT04838041)

This Phase II study aims to evaluate the outcomes of patients with chronic-phase chronic myeloid leukemia (CML) who previously attempted TKI discontinuation and resumed the same TKI upon relapse.

Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
(Clinicaltrials.gov Identifier: NCT06629584)

This Phase 2 open-label study aims to evaluate the efficacy of asciminib in patients previously treated with one line of TKI therapy by assessing the rate of major molecular response (MMR) at 12 months.

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Recruiting
Estimated enrolment: 40 participants

Asciminib Prospective Non-Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML- CP in Real World Setting in France (ASSURE-3)
(Clinicaltrials.gov Identifier: NCT06092879)

This study aims to gather real-world data on asciminib treatment patterns, focusing on patient retention at 12 months to enhance understanding of its use in a broader population.

Asciminib RMP Study
(Clinicaltrials.gov Identifier: NCT05943522)

This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of asciminib in the real-world clinical setting in Korean chronic myeloid leukemia (CML) patients.

ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML
(Clinicaltrials.gov Identifier: NCT03595917)

This study aims to evaluate the safety and efficacy of ABL001 in combination with dasatinib and prednisone as a potential treatment for BCR-ABL+ B-cell acute lymphoblastic leukemia (Ph+ ALL) and chronic myeloid leukemia in lymphoid blast crisis.

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ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants (CML)
(Clinicaltrials.gov Identifier: NCT06787144)

This study aims to evaluate the safety, tolerability, and optimal dose of ELVN-001 in Japanese patients with chronic-phase CML, with or without T315I mutations, who have failed, are intolerant to, or are ineligible for at least two prior TKIs.

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A Phase 1a/​1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia (CML)
(Clinicaltrials.gov Identifier: NCT05304377)

This study aims to evaluate the safety, tolerability, and optimal dose of ELVN-001 in patients with CML, with or without T315I mutations, who are relapsed, refractory, or intolerant to TKIs.

USA: 3
Australia: 1
Canada: 1
France: 7
Germany: 7
Israel: 3
Rep. of Korea: 5
Spain: 5
UK: 2

A Study of HS-10382 in Patients With Chronic Myeloid Leukemia
(Clinicaltrials.gov Identifier: NCT05367700)

This study aims to evaluate the safety, tolerability, pharmacokinetics, and anti-CML activity of HS-10382, an oral allosteric BCR-ABL1 inhibitor, in patients with chronic myeloid leukemia (CML).

Study of Olverembatinib (HQP1351) in Patients With CP-CML (POLARIS-2)
(Clinicaltrials.gov Identifier: NCT06423911)

This Phase 3 global multicenter study aims to evaluate the efficacy of olverembatinib in chronic-phase CML, comparing its MMR rate to bosutinib in patients without the T315I mutation and assessing its therapeutic benefits in those with the mutation.

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Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
(Clinicaltrials.gov Identifier: NCT04260022)

This Phase Ib multi-center, open-label study aims to evaluate the pharmacokinetics and determine the recommended Phase 2 dose of HQP1351 in patients with CML (CP, AP, or BP) or Ph+ ALL who have experienced resistance or intolerance to prior TKIs.

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A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia
(Clinicaltrial.gov Identifier: NCT06401603)

This study aims to determine the recommended safe and biologically effective doses of lisaftoclax and olverembatinib in combination with decitabine for participants with advanced CML and Ph+ AML.

Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs
(Clinicaltrials.gov Identifier: NCT05311943)

This study aims to evaluate the efficacy and safety of olverembatinib in chronic-phase CML patients who are resistant or intolerant to at least two second-generation TKIs, with efficacy measured by major molecular response (MMR) at 12 months.

Efficacy and Safety of Dose Redution of Radotinib as a First Line Treament in Ph+ CML
(Clinicaltrial.gov Identifier: NCT06665412)

This observational study aims to evaluate the efficacy and safety of radotinib dose reduction in Ph+ CML patients, with the primary outcome assessed by the MMR rate at 12 months.

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A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs
(Clinicaltrials.gov Identifier: NCT03459534)

This Phase III multinational, multicenter, single-arm study aims to evaluate the efficacy and safety of radotinib in chronic-phase Ph+ CML patients who have failed or are intolerant to previous TKI therapies, including Imatinib.

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Rep. of Korea: 1
Russia: 6
Turkey: 6
Ukraine: 5

CARDINAL- A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia
(Clinicaltrials.gov Identifier: NCT06163430)

USA: 9
Australia: 2
France: 5
Germany: 6
Italy: 5
Rep. of Korea: 4
Spain: 9

TGRX-678 US Phase I for Subjects with Refractory or Advanced Chronic Myelogenous Leukemia
(Clinicaltrials.gov Identifier: NCT06088888)

This single-arm, open-label study aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of TGRX-678 in CML patients who have failed or are intolerant to TKI treatments.

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TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients
(Clinicaltrials.gov Identifier: NCT06453902)

This Phase II single-arm, open-label, multicenter study aims to evaluate the safety and efficacy of TGRX-678 in accelerated-phase CML patients who have relapsed or are refractory to third-generation TKI treatment, including those with or without the T315I mutation.

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