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New treatment option for CML,Blast Phase
Official title Olverembatinib Combined With Venetoclax and Azacitidine in Blast Phase Ph Chromosome-positive CML
ClinicalTrials.gov ID: NCT06757855
What this study is testing
What is Olverembatinib?
Olverembatinib is an investigational medicine, being studied as a potential treatment for cml,blast phase.
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
- Even in the TKI era, the outcoms of patients with blast phase is still poor.The response rate to conventional intensive chemotherapy is only 12.5% and the 5-year survival rate is 0 for patients with myeloid blast crsis. The response rate of TKI monotherapy is about 50% and the response rate is further improved when combined TKI and chemotherapy for patients with lymphoid blast crsis.
- 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 15 and older
You may be able to join if
- Patients with t(9;22)(q34;q11)/BCR::ABL1 positive blast-phase CML who are aged 15 years or older, whether initially in the blast phase or progressing...
- ECOG performance status score ≤ 2.
- Major organ function assessment criteria: Total bilirubin \< 1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine...
- Men and women of reproductive potential agree and adopt effective contraceptive measures.
- The informed consent form is signed by the patient himself/herself or an immediate family member. Considering the patient's condition, if the...
You likely can't join if
- Before group entry, other systemic anti-cancer treatments for acute transformation were received (excluding single-agent TKI, hormone, or hydroxyurea...
- Myocardial infarction occurred within 12 months before enrollment in this study; other clinically significant cardiac diseases (such as unstable...
- Uncontrolled active severe infection
- Known positive serum HIV
- Acute pancreatitis occurred within 1 year before study screening, or a history of chronic pancreatitis
- Uncontrolled hypertriglyceridemia (triglycerides \> 450 mg/dL, i.e., 5.1 mmol/L) or hypercholesterolemia (total cholesterol (TC) ≥ 6.2 mmol/L)
See the full eligibility criteria
- Patients with t(9;22)(q34;q11)/BCR::ABL1 positive blast-phase CML who are aged 15 years or older, whether initially in the blast phase or progressing from the chronic phase, with no gender restriction. Blast phase...
- ECOG performance status score ≤ 2.
- Major organ function assessment criteria: Total bilirubin \< 1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN; serum creatinine \< 2×ULN; myocardial enzymes...
- Men and women of reproductive potential agree and adopt effective contraceptive measures.
- The informed consent form is signed by the patient himself/herself or an immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the control of the disease, the legal...
- Before group entry, other systemic anti-cancer treatments for acute transformation were received (excluding single-agent TKI, hormone, or hydroxyurea for reducing tumor burden before group entry, and single-agent...
- Myocardial infarction occurred within 12 months before enrollment in this study; other clinically significant cardiac diseases (such as unstable angina, congestive heart failure, uncontrollable hypertension...
- Uncontrolled active severe infection
- Known positive serum HIV
- Acute pancreatitis occurred within 1 year before study screening, or a history of chronic pancreatitis
- Uncontrolled hypertriglyceridemia (triglycerides \> 450 mg/dL, i.e., 5.1 mmol/L) or hypercholesterolemia (total cholesterol (TC) ≥ 6.2 mmol/L)
- Another malignancy diagnosed and treated within 5 years before diagnosis, or previously diagnosed with another malignancy with evidence of residual disease. Patients with non-melanoma skin cancer or any type of...
- Pregnant or lactating women
- Clinical manifestations of CNS leukemia or extramedullary infiltration
- Uncontrolled diabetes, defined as glycated hemoglobin value \> 7.5%. Patients with previously existing but well-controlled diabetes need not be excluded
- Mental illness that may prevent the subject from completing treatment or providing informed consent
- Other conditions considered unsuitable for this study by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
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, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. 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.