Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase
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|ClinicalTrials.gov Identifier: NCT05143840|
Recruitment Status : Recruiting
First Posted : December 3, 2021
Last Update Posted : July 18, 2022
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia, Chronic Phase Adult CML Leukemia, Myeloid Leukemia,Myeloid, Chronic||Drug: Asciminib Drug: Ascimininb + Nilotinib||Phase 2|
Asciminib is a potent allosteric inhibitor of BCR-ABL1 oncogene that confers resistance to tyrosine kinase inhibitors (TKIs). Asciminib has potential to combine with TKIs to prevent the emergence of BCR-ABL1 mutations, increasing the depth of molecular response in CML-CP patients. Anticipated enrollment is 50 subjects across sites.
To estimate the proportion of patients with previously untreated CML-CP attaining deep molecular response (PCR blood test).
- To estimate the proportion of patients achieving molecular response at specific time points
- To estimate the time to molecular response
- To evaluate the duration of hematologic and molecular response to asciminib
- To define the time to progression and overall survival for patients with CML in early CP treated with asciminib
- To evaluate the safety profile of asciminib in patients with CML-CP
- To evaluate the development of ABL mutations for patients with CML in early CP treated with asciminib
- To analyze differences in response rates and in prognosis within different risk groups and patient characteristics
- To evaluate patient-reported outcomes in patients with CML receiving asciminib
- To investigate treatment-free remission after at least 2 years of sustained deep molecular remission for patients receiving single agent asciminib
- To evaluate the safety and efficacy of concomitant use of nilotinib with asciminib in patients who have not achieved MR4.5.
- To evaluate the rate of successful treatment discontinuation for patients using the combination of asciminib and nilotinib
- Evaluate the role of Digital droplet PCR (ddPCR) in predicting TFR
- Evaluating the correlation between the gene expression signature of patients and the chances of achieving MMR and DMR
- Evaluate whether B, NK and T cells DNA mutation and RNA expression are relevant and whether they can predict response in patients with CML using single cell analysis.
Subjects must meet all inclusion criteria and none of the exclusion criteria of the study. No enrollment waivers will be granted. After successful screening, subjects will be enrolled and treatment will start within 7 days of enrollment. Eligible subjects will begin asciminib on cycle 1 day 1 of the trial. After 2 years, subjects will be offered the addition of taking nilotinib with asciminib if a molecular response is not met (PCR blood test).
Duration of each participant is expected to take approximately 5 years.
Regimen Description Study Drug Dose Route Schedule Cycle Length Asciminib 40 mg Oral Twice a day (BID) 4 weeks (28 days) Nilotinib 300 mg* Oral Twice a day (BID) 4 weeks (28 days)
*Nilotinib will be taken if indicated at a maximum dose of 300mg BID
Dose levels and dose modifications of the study drugs will be made per protocol.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single group frontline asciminib|
|Masking:||None (Open Label)|
|Official Title:||Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase|
|Actual Study Start Date :||April 22, 2022|
|Estimated Primary Completion Date :||February 2025|
|Estimated Study Completion Date :||February 2027|
Asciminib 40mg taken orally twice a day starting cycle 1 day 1 for up to 24 months.
Potent tyrosine kinase inhibitor that displays anti-tumor activity by specifically targeting the ABL myristate-binding pocket (STAMP).
Other Name: ABL001
Drug: Ascimininb + Nilotinib
For subjects that do not achieve MR4.5 (molecular response) after 24 months of single-agent asciminib will be offered the addition of nilotinib 300mg, twice daily, with the goal of attaining MR4.5.
- Primary Outcome Measure 1: Deep Molecular Response [ Time Frame: 24 months ]This measure is the number of subjects in deep molecular response (DMR) defined as breakpoint cluster region ABL proto-oncogene 1 (BCR-ABL1) <0.0032% International Standard (IS) by real-time quantitative polymerase chain reaction (RT-PCR).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05143840
|Contact: Kelly Jenkins, MSN, RNfirstname.lastname@example.org|
|Contact: GCC Clinical Trials Office||706-721-2505||Cancer_Center_Trials@augusta.edu|
|United States, Georgia|
|Georgia Cancer Center at Augusta University||Not yet recruiting|
|Augusta, Georgia, United States, 30912|
|Contact: Kelly Jenkins, MSN, RN 706-721-1206 email@example.com|
|Contact 706-721-2505 Cancer_Center_Trials@augusta.edu|
|Principal Investigator: Jorge E. Cortes, MD|
|United States, Wisconsin|
|Froedtert Hospital & the Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Ehab Atallah, MD 414-805-4600 firstname.lastname@example.org|