A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Ph+ALL
Recruiting
Phase 2
Interventional Study
Acute Lymphoblastic Leukemia
Philadelphia Chromosome
Philadelphia-Positive ALL
Adult ALL
IKZF1 Gene Mutation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 67 (estimated)
- Sponsor
- Nanfang Hospital, Southern Medical University · Other
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About This Trial
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 reg…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Signed written informed consent;
2. Newly diagnosed adult B-precursor Ph+ ALL;
3. Age greater or equal to 18 years;
4. ECOG Performance Status 0-1;
5. Ineligible for allo-HSCT.
6. Renal and hepatic function as defined below:
AST (GOT), ALT (GPT), and AP \<2 x upper limit …
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