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.
PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Blinatumomab for Philadelphia Chromosome-Positive

To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.

Official registry: https://clinicaltrials.gov/study/NCT06308588 · M.D. Anderson Cancer Center · enrollment listed as 40

What this phase means

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 Blinatumomab, or Asciminib. The registry lists allocation as na. To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.

They plan to enroll about 40 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Interventions: Blinatumomab, Asciminib

Primary outcome (registry wording): Safety and adverse events (AEs)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Diagnosis of one of the following:
  • i. If they are in morphologic remission at enrollment, they are evaluable only MRD responses, RFS and OS b) Participants ≥ 12 years of age with relapsed/refractory Ph-positive ALL or with previously treated lymphoid blast phase CML
  • Performance status ≤2 (ECOG Scale) if age ≥18 years or Lansky ≥50 if age \<18 years
  • Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):
  • Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome
  • Alanine aminotransferase (ALT) ≤ 3 x ULN, OR
  • Aspartate aminotransferase (AST) ≤ 3 x ULN

Public study contact (from the registry)

Nicholas Short, MD

(713) 563-4485

nshort@mdanderson.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland
Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

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.

NCT00106925 · Official ClinicalTrials.gov record · National Heart, Lung, and Blood Institute (NHLBI)

RecruitingNot a traditional drug phaseBethesda, Maryland
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocy…

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.

NCT00923507 · Official ClinicalTrials.gov record · National Heart, Lung, and Blood Institute (NHLBI)

FAQ about this NCT record

Is NCT06308588 still recruiting?

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 NCT06308588?

Phase 1 / 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 NCT06308588?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary