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Clinical Trial NCT07428486 for Phase I, FLAG Chemotherapy, Lisaftoclax, Pelcitoclax, Relapsed/Refractory, Lymphoblastic Leukemia Acute is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
M.D. Anderson Cancer CenterA Phase 1 Study Of FLAG Chemotherapy In Combination With Lisaftoclax And Pelcitoclax In Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia Phase 1 24
Primary Objectives
• To establish the minimum safe and biologically-effective doses of lisaftoclax and pelcitoclax in combination with FLAG chemotherapy
Secondary Objectives
- To determine the CR/CRi rate of the combination regimen
- To assess other efficacy endpoints (CR rate, measurable residual disease negativity by flow cytometry and clonoSEQ, relapse-free survival, overall survival, event-free survival)
- To ...
A Phase 1 Study Of FLAG Chemotherapy In Combination With Lisaftoclax And Pelcitoclax In Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia
- 2025-1676
- NCI-2026-01274 (Other Identifier) (NCI-CTRP Clinical Registry)
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalComb Treatment with FLAG + Lisaftoclax (PO)+ Pelcitoclax (IV) Q4W 5 cycles of the FLAG chemotherapy in combination with lisaftoclax and pelcitoclax | Fludarabine Given by IV Cytarabine Given by IV G-CSF Given by Injection Lisaftoclax Given by Po Pelcitoclax Given by Iv |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Safety and adverse events | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | Through study completion; an average of 1 year |
Diagnosis: Age ≥18 years with relapsed or refractory T-cell ALL.
Performance status ≤2 (ECOG Scale).
Adequate liver, cardiac, renal and pancreatic function as defined by the following criteria:
- Total serum bilirubin <2x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <3 x ULN, unless due to the underlying leukemia approved by the PI
- Creatinine clearance ≥30 mL/min
- Ejection fraction ≥40%
Ability to understand and the willingness to sign a written informed consent document
Willingness to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after completion of study participation. For women of childbearing potential, adequate methods of contraception include: complete abstinence, hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal Ligation or hysterectomy, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide.
Participant s who previously received lisaftoclax or any Bcl-xL inhibitor
Active and uncontrolled infection
Active secondary malignancy. Participant s with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the PI.
Clinically significant, uncontrolled, active cardiovascular disease, including active grade III-V cardiac failure as defined by the New York Heart Association Criteria
Prior investigational therapy within 14 days of enrollment, unless the participant has rapidly progressive disease judged to be life-threatening by the investigator. Cytoreduction with corticosteroids and/or hydroxyurea, is permitted.
Recent exposure to strong inducer of CYP3A or p-glycoprotein within 14 days of study enrollment, or 5 half-lives, whichever is longer. Agents include but are not limited to: carbamazepine, phenytoin, rifampin, and St. John's wart
Pregnant or lactating women
Inability to swallow
Unable or unwilling to sign the consent form
Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection
o Note: Participants who have isolated positive hepatitis B core antibody (ie, in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. Participants who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cytarabine, filgrastim, pegfilgrastim, lisaftoclax, and pelcitoclax or other agents used in study.
Participants with psychiatric illness/social situations that would limit compliance with study requirements.
M.D. Anderson Cancer CenterAscentage Pharma Group Inc.Texas