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Compares treatment options for ALL, Adult
Official title RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.
ClinicalTrials.gov ID: NCT06250959
What this study is testing
What is Blinatumomab Injection [Blincyto]?
Blinatumomab Injection [Blincyto] is an investigational medicine, being studied as a potential treatment for all, adult.
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
- In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.
- Phase 2: a mid-size study of how well it works
- 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 15 to 65
You may be able to join if
- Age 15-65
- Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria
- Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ≦5 days
- ECOG score 0-3
- Liver function: total bilirubin ≦ 3 times the upper limit of normal; Alanine aminotransferase ≦ 3 times upper limit of normal motion; Aspartate...
You likely can't join if
- Ph+ (BCR-ABL1 positive) ALL
- T cells ALL
- Mature B-cell leukemia/lymphoma, B-cell lymphoma, with extramedullary disease
- Acute mixed-cell leukemia
- Central nervous system leukemia
- HIV infection
See the full eligibility criteria
- Age 15-65
- Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria
- Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ≦5 days
- ECOG score 0-3
- Liver function: total bilirubin ≦ 3 times the upper limit of normal; Alanine aminotransferase ≦ 3 times upper limit of normal motion; Aspartate aminotransferase ≦ 3 times upper limit of normal motion; (except...
- Renal function: endogenous creatinine clearance ≧30ml/min
- Patients must be able to understand and willing to participate in the study and must sign the informed consent form.
- Ph+ (BCR-ABL1 positive) ALL
- T cells ALL
- Mature B-cell leukemia/lymphoma, B-cell lymphoma, with extramedullary disease
- Acute mixed-cell leukemia
- Central nervous system leukemia
- HIV infection
- HBV-DNA or HCV-RNA positive
- Patients with grade 2 or higher heart failure and other patients deemed inappropriate for inclusion by the investigator
- Pregnant or breastfeeding patients
- The study patient was refused enrollment
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, 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 to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, 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.