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Tyrosine Kinase Inhibitor

Asciminib for Chronic Myeloid Leukemia (ASC2ESCALATE Trial)

Verified Trial
Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
You have chronic myeloid leukemia that is not is the blastic or accelerated phase
Be older than 18 years old
Must not have
History of other active malignancy within 3 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively.
You have not had a stem-cell transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 3, 6, 12, 18, and 24 months
Awards & highlights

ASC2ESCALATE Trial Summary

This trialwill test a new drug to treat chronic myeloid leukemia in those who haven't responded to other treatments.

Who is the study for?
This trial is for adults with chronic myeloid leukemia who have either failed or couldn't tolerate their first treatment, or are newly diagnosed and treated briefly. They should be in good physical condition, not in the advanced stages of leukemia, and without serious heart issues or a history of certain other cancers.Check my eligibility
What is being tested?
Asciminib (Scemblix) is being tested as a solo treatment for chronic myeloid leukemia. The study will include patients previously treated with one TKI drug that didn't work well or caused side effects, as well as new patients who've had minimal prior treatment.See study design
What are the potential side effects?
While specific side effects aren't listed here, asciminib may cause changes in blood counts, liver enzymes, pancreatitis risk increase; it could also affect heart rhythm potentially leading to severe cardiac events.

ASC2ESCALATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My chronic myeloid leukemia is in the early or chronic phase.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't had any cancer except for basal cell skin cancer or treated carcinoma in situ in the last 3 years.
Select...
I have not undergone a stem-cell transplant.
Select...
I have never taken the medication Scemblix.
Select...
My heart has no abnormalities.

ASC2ESCALATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 3, 6, 12, 18, and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 3, 6, 12, 18, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants who achieve Major Molecular Response (MMR) in the 2L setting
Secondary outcome measures
Duration of MMR
MMR Rate - All scheduled time points
MR2 Rate - All scheduled time points
+8 more
Other outcome measures
To investigate MR2, MR4, MR4.5 rate at visit

ASC2ESCALATE Trial Design

1Treatment groups
Experimental Treatment
Group I: AsciminibExperimental Treatment1 Intervention
80 mg initial oral dose taken once a day with possible dose escalation

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,853 Previous Clinical Trials
4,197,623 Total Patients Enrolled
Rodrigo Maegawa, MDStudy DirectorNovartis
Daisy Yang, PhDStudy DirectorNovartis

Media Library

Asciminib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05384587 — Phase 2
Chronic Myelogenous Leukemia Research Study Groups: Asciminib
Chronic Myelogenous Leukemia Clinical Trial 2023: Asciminib Highlights & Side Effects. Trial Name: NCT05384587 — Phase 2
Asciminib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05384587 — Phase 2

Frequently Asked Questions

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

Are there any slots remaining in this research endeavor for participants?

"Yes indeed. The clinical trial, initially advertised on August 29th 2022 and recently amended on January 5th 2023, is registering 92 patients across 4 medical centres as indicated by the information hosted on ClinicalTrials.gov."

Answered by AI

Has the FDA affirmed Asciminib for use in treatment?

"The safety of Asciminib was rated a 2 as this is still in phase two, and thus there are no long-term efficacy data but some short-term evidence supporting its security."

Answered by AI

Are there a variety of locations offering this investigation in the city?

"Currently, Rocky Mountain Cancer Centers USOR in Boulder, Hematology Oncology Care in Cincinnati, and Texas Oncology P A TX Oncology Baylor in Dallas are actively recruiting. Additionally there 4 additional sites with available clinical trial positions."

Answered by AI

How many participants have signed up for the research project?

"Affirmative. The clinicaltrials.gov website reveals that this study is currently seeking participants, having been initially posted on August 29th 2022 and last updated on January 5th 2023. From 4 different sites they are looking to find 92 individuals for enrolment into the trial."

Answered by AI

Who else is applying?

What site did they apply to?
Novant Health Heart and Vascular Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
~67 spots leftby Feb 2025