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New treatment option for Philadelphia Chromosome-Positive
Official title Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT06308588
What this study is testing
What is Blinatumomab?
Blinatumomab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for philadelphia chromosome-positive.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of one of the following: a) Participants ≥18 years of age with previously untreated or minimally pretreated Ph-positive ALL who are not...
- Performance status ≤2 (ECOG Scale) if age ≥18 years or Lansky ≥50 if age \<18 years
- Weight ≥40kg
- 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
You likely can't join if
- Active serious infection not controlled by oral or intravenous antibiotics.
- Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will...
- Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.
- Prolonged QTc interval on pre-entry electrocardiogram (\> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist
- History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain...
- Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side...
See the full eligibility criteria
- Diagnosis of one of the following: a) Participants ≥18 years of age with previously untreated or minimally pretreated Ph-positive ALL who are not suitable candidates for intensive chemotherapy. Participants who have...
- Performance status ≤2 (ECOG Scale) if age ≥18 years or Lansky ≥50 if age \<18 years
- Weight ≥40kg
- 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
- Adequate renal function defined as: a) Creatinine clearance ≥30 mL/min
- Adequate pancreatic function as defined by the following criteria: a) Serum lipase and amylase \< 1.5 x ULN
- Adequate cardiac function as assessed clinically by history and physical examination.
- For females of childbearing potential, a negative urine pregnancy test must be documented
- Willingness to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study participation. For women of child-bearing potential, adequate methods...
- Ability to understand and the willingness to sign a written informed consent document.
- Signed informed consent
- Active serious infection not controlled by oral or intravenous antibiotics.
- Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year.
- Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.
- Prolonged QTc interval on pre-entry electrocardiogram (\> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist
- History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain...
- Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged...
- Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not...
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.