Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
This is a multi-center, prospective, single-arm, non-randomly assigned, treatment phase II study of CML patients in first or second chronic phase (i.e. after allogeneic stem cell transplantation) and proven BCR::ABL1 T315I mutation.
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are asciminib 200 mg BID. The registry lists allocation as na. This is a multi-center, prospective, single-arm, non-randomly assigned, treatment phase II study of CML patients in first or second chronic phase (i.e.
They plan to enroll about 50 people at 10 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Efficacy of Asciminib in Chronic Phase CML Patients With T315I Mutations
Interventions: asciminib 200 mg BID
Primary outcome (registry wording): Rate of MR2 at 12 months
Who it is for (from inclusion criteria)
Ages 18 Years to any
Male or female patients with BCR::ABL1 positive CML in first or second chronic phase (i.e. after allogeneic stem cell transplantation) and proven T315I mutations detected by Sanger sequencing or NGS
Age ≥ 18 years old (no upper age limit is given)
how well you can do daily activities (ECOG score) of ≤2
Serum levels of potassium, magnesium, total calcium within the normal limits (≥LLN \[lower limit of normal\] and ≤ULN \[upper limit of normal\]). Correction of electrolytes levels with supplements to fulfil enrolment criteria is allowed
AST and ALT ≤2.5 x ULN or 5.0 x ULN if considered due to leukemia
Alkaline phosphatase ≤2.5 x ULN unless considered due to leukemia
Total bilirubin ≤1.5 x ULN, except known Gilbert disease
Who the registry excludes
Pre-treatment with asciminib
BCR::ABL1 variants lacking ABL1 exon a2
Known impaired cardiac function, including any of the following:
Congenital long QT syndrome
History of or presence of clinically significant ventricular or atrial tachyarrhythmia
QTc \>450 msec on screening ECG
Myocardial infarction within 12 months prior to starting therapy
This study will provide follow-up evaluation and care of patients who have undergone allogeneic (donor) stem cell transplantation at the NIH Clinical Center. Patients are monitored for their response to treatment, disease relapse, and later-occurring effects of the transplant.
Background The development of new technologies now allow scientists to investigate the molecular basis and clinical manifestations of monoclonal B cell lymphocytosis (MBL), chronic lymphocytic leukemia(CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia (WM), and splenic marginal zone lymphoma (SMZL). Applying these methods in a natural history study can help identify processes involved in disease progression, and possibly lead to the discovery or validation of treatment targets.
Background: Cancer has a major impact in the United States and across the world. In 2015, over 1.5 million new cases of cancer were diagnosed in the U.S.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07789574?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07789574?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.