BridgeMD
New treatment option for Acute Lymphoblastic Leukemia
Official title A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Ph+ALL
ClinicalTrials.gov ID: NCT06220487
What this study is testing
What is Prednisone, Olverembatinib, Blinatumomab, Chidamide?
Prednisone, Olverembatinib, Blinatumomab, Chidamide is an investigational medicine, 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
- ABC study is a phase 2, single-arm, open-label study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in patients with newly diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ALL). This study combined third generation TKI (Olverembatinib), histone deacetylase inhibitors (Chidamide) and CD3/CD19 bispecific T-cell engager (Blinatumomab) as first line regimen (ABC regimen) for 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
- Signed written informed consent;
- Newly diagnosed adult B-precursor Ph+ ALL;
- Age greater or equal to 18 years;
- ECOG Performance Status 0-1;
- Ineligible for allo-HSCT.
You likely can't join if
- History of receiving systemic chemotherapy or CAR-T therapy for ALL. Impaired cardiac function, including any one of the following: .LVEF \<45% as...
- ST depression of \>1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads. .Congenital long QT syndrome. .History of or...
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of olverembatinib or chidamide (e.g...
- Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least...
- Not eigiable for this study, decided by PI
See the full eligibility criteria
- Signed written informed consent;
- Newly diagnosed adult B-precursor Ph+ ALL;
- Age greater or equal to 18 years;
- ECOG Performance Status 0-1;
- Ineligible for allo-HSCT.
- Renal and hepatic function as defined below: AST (GOT), ALT (GPT), and AP \<2 x upper limit of normal (ULN). Creatinine clearance equal or greater than 50 mL/min.
- Pancreatic function as defined below: Serum amylase less or equal to 1.5 x ULN Serum lipase less or equal to1.5 x ULN
- Normal cardiac function;
- Negative HIV test, negative HBV DNA and HCV RNA;
- Negative pregnancy test in women of childbearing potential.
- History of receiving systemic chemotherapy or CAR-T therapy for ALL. Impaired cardiac function, including any one of the following: .LVEF \<45% as determined by MUGA scan or echocardiogram. .Complete left bundle branch...
- ST depression of \>1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads. .Congenital long QT syndrome. .History of or presence of significant ventricular or atrial arrhythmia. .Clinically...
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of olverembatinib or chidamide (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption...
- Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective...
- Not eigiable for this study, decided by PI
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 and older. 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.