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Asciminib for Chronic Myeloid Leukemia

Phase 2
Waitlist Available
Led By Ghayas C Issa
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have received TKI therapy for at least 24 months and not have required dose reductions, escalations, discontinuation or re-initiation after discontinuation of TKI in the last 6 months
Patients with a diagnosis of Philadelphia chromosome (Ph)- or BCR-ABL1-positive CML (as determined by cytogenetics, fluorescence in situ hybridization [FISH], or polymerase chain reaction [PCR])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights

Study Summary

This trial is studying ABL001 as a possible treatment for CML patients who are already on TKI therapy. ABL001 may work by blocking enzymes needed for cell growth. Giving ABL001 and TKI together may be more effective than TKI alone.

Who is the study for?
This trial is for chronic myeloid leukemia patients who've been on tyrosine kinase inhibitor therapy for at least 2 years without needing changes in the last 6 months. They must have certain levels of disease markers and normal organ function tests. Pregnant women, those with severe heart conditions or infections like HIV, and anyone with a history of pancreatitis or other active cancers are excluded.Check my eligibility
What is being tested?
The study is testing ABL001's effectiveness when combined with tyrosine kinase inhibitors in treating chronic myeloid leukemia. It aims to see if this combination works better than the inhibitor alone by blocking enzymes that cancer cells need to grow.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include issues related to enzyme inhibition such as fatigue, digestive problems, skin reactions, liver abnormalities, and an increased risk of infection due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've been on TKI therapy for 2+ years without changes in the last 6 months.
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My leukemia is positive for the Philadelphia chromosome or BCR-ABL1.
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I agree to use effective birth control during and after the study.
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I am currently on nilotinib or dasatinib at a standard dose or lower.
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My cancer is in a controlled phase according to recent tests.
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My leukemia has not responded well enough to my current treatment.
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I haven't stopped my TKI therapy for more than 14 days at a time, except for specific reasons.
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I can take care of myself and do some daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of molecular response
Secondary outcome measures
Event free survival
Mismatch repair status
Overall survival
+1 more
Other outcome measures
Incidence of adverse events
Interference score
MD Anderson Symptom Inventory (MDASI)-Chronic Myeloid Leukemia (CML) score
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (asciminib)Experimental Treatment1 Intervention
Patients receive asciminib PO BID for up to 36 months while receiving standard of care dasatinib or nilotinib in the absence of disease progression or unacceptable toxicity. Patients may continue to receive asciminib after 36 months at the discretion of investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Asciminib
2018
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,409 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,606 Total Patients Enrolled
Ghayas C IssaPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Asciminib Clinical Trial Eligibility Overview. Trial Name: NCT04216563 — Phase 2
Chronic Myelogenous Leukemia Research Study Groups: Treatment (asciminib)
Chronic Myelogenous Leukemia Clinical Trial 2023: Asciminib Highlights & Side Effects. Trial Name: NCT04216563 — Phase 2
Asciminib 2023 Treatment Timeline for Medical Study. Trial Name: NCT04216563 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Asciminib been tested in any other previous trials?

"Presently, 15 separate trials are evaluating the effects of Asciminib. Of those investigations 4 have progressed to Phase 3. Predominantly located in Houston, Texas, this medical intervention is being studied at 487 sites worldwide."

Answered by AI

Is this study presently open to enrollment?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, whose initial listing was on July 29th 2020 is presently seeking volunteers. 40 individuals need to be recruited from a single location for the study to move forward."

Answered by AI

How many participants are currently taking part in this medical research?

"Affirmative, the information hosted on clinicaltrials.gov declares that this study is actively searching for participants. This particular trial was initially listed on July 29th 2020 and most recently updated February 1st 2022; they are seeking 40 individuals at a single medical centre."

Answered by AI

Is this medical experiment novel in its approach?

"The development of Asciminib has been tracked since 2014 when it was first trialled by Novartis Pharmaceuticals. It progressed to Phase 1 approval after a 326 patient trial in the same year and is now being tested in 15 different clinical studies spanning 45 countries and 146 cities."

Answered by AI

Has the FDA accepted Asciminib as a viable treatment option?

"Asciminib is rated a 2, as the Phase 2 trial implies that while there has been evidence of safety, efficacy hasn't yet been demonstrated."

Answered by AI
~13 spots leftby Dec 2025