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Tests treatment safety and results for Acute Lymphoblastic Leukemia
Official title Efficacy of Targeted Drugs Combined With Chemotherapy in the Treatment of T-ALL
ClinicalTrials.gov ID: NCT07203352
What this study is testing
What is targeted drug?
targeted drug is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute lymphoblastic leukemia.
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
- This prospective, randomized, controlled trial evaluates the efficacy and safety of a new targeted drug combined with chemotherapy versus standard chemotherapy alone. Eligible patients were randomized 1:1 to either the treatment or control group.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- The people were diagnosed with acute T-lymphocytic leukemia (according to the 2016 WHO classification) based on their bone marrow pathology and...
- The people must have never received anti-leukemia treatment before;
- Age ≥ 18 years old, gender not restricted;
- The people' Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;
- The people or their legal representatives must provide written informed consent before undergoing the special examinations or procedures of the study.
You likely can't join if
- Classified as other types of leukemia according to the WHO 2016 classification;
- Previously received systemic or local treatments including chemotherapy;
- Previously underwent hematopoietic stem cell transplantation;
- Had other tumors in addition to leukemia;
- Had uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, severe infectious diseases, etc.;
- Patients with a history of allergic reactions to any drugs in this research protocol;
See the full eligibility criteria
- The people were diagnosed with acute T-lymphocytic leukemia (according to the 2016 WHO classification) based on their bone marrow pathology and hematology, and sufficient bone marrow samples were available for PCR...
- The people must have never received anti-leukemia treatment before;
- Age ≥ 18 years old, gender not restricted;
- The people' Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;
- The people or their legal representatives must provide written informed consent before undergoing the special examinations or procedures of the study.
- Classified as other types of leukemia according to the WHO 2016 classification;
- Previously received systemic or local treatments including chemotherapy;
- Previously underwent hematopoietic stem cell transplantation;
- Had other tumors in addition to leukemia;
- Had uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, severe infectious diseases, etc.;
- Patients with a history of allergic reactions to any drugs in this research protocol;
- Left ventricular ejection fraction ≤ 50%;
- Laboratory test values at screening (unless caused by leukemia): ALT or AST higher than twice the upper limit of normal, AKP and bilirubin higher than 1.5 times the upper limit of normal, creatinine level higher than...
- Other concurrent and uncontrolled medical conditions that the researcher considers will affect the patient's participation in the study;
- Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;
- Pregnant or lactating women;
- HIV-infected individuals.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, 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.