Phase IPhase 1NCT07428486
A Phase 1 Study Of FLAG Chemotherapy In Combination With Lisaftoclax And Pelcitoclax In Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia
A Phase 1 study testing Fludarabine, Cytarabine and G-CSF in people with Phase I and FLAG Chemotherapy, run by M.D. Anderson Cancer Center.
Trial summary
To find safe and effective doses of lisaftoclax and pelcitoclax in combination with FLAG chemotherapy in patients with relapsed/refractory T-ALL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phase I, FLAG Chemotherapy, Lisaftoclax
- What is being tested?
- Fludarabine, Cytarabine and G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Apr 2026to 27 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
About this study
To find safe and effective doses of lisaftoclax and pelcitoclax in combination with FLAG chemotherapy in patients with relapsed/refractory T-ALL.
Read the detailed description
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 determine the safety of the combination regimen
- Conditions
- Phase I, FLAG Chemotherapy, Lisaftoclax, Pelcitoclax, Relapsed/Refractory, Lymphoblastic Leukemia Acute
- Being tested
- Fludarabine, Cytarabine, G-CSF, Lisaftoclax, Pelcitoclax
- Medical subject headings
- Recurrence, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Given by IV
CytarabineDrug
Given by IV
G-CSFDrug
Given by Injection
LisaftoclaxDrug
Given by Po
PelcitoclaxDrug
Given by Iv
| Study group | Role | What they receive |
|---|---|---|
| Comb Treatment with FLAG + Lisaftoclax (PO)+ Pelcitoclax (IV) Q4W | Experimental | 5 cycles of the FLAG chemotherapy in combination with lisaftoclax and pelcitoclax Receives: Drug: Fludarabine; Drug: Cytarabine; Drug: G-CSF; Drug: Lisaftoclax; Drug: Pelcitoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start27 Apr 2026
- Primary completion27 Apr 2026
- Study completion27 Apr 2026
Why it stopped: PI requested
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase IStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ascentage Pharma Group Inc.
- Responsible party
- Sponsor
- Investigators
- Nicholas J Short, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428486
- Sponsor's protocol ID
- 2025-1676
- Other IDs
- NCI-2026-01274
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Of FLAG Chemotherapy In Combination With Lisaftoclax And Pelcitoclax In Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07428486
- Acronym / sponsor ID
- 2025-1676
- Conditions
- Phase I, FLAG Chemotherapy, Lisaftoclax, Pelcitoclax, Relapsed/Refractory, Lymphoblastic Leukemia Acute
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI requested
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Ascentage Pharma Group Inc.
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 27 Apr 2026 (actual)
- Study completion
- 27 Apr 2026 (actual)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To find safe and effective doses of lisaftoclax and pelcitoclax in combination with FLAG chemotherapy in patients with relapsed/refractory T-ALL.
Detailed description
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 determine the safety of the combination regimen
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comb Treatment with FLAG + Lisaftoclax (PO)+ Pelcitoclax (IV) Q4W | Experimental | Drug: Fludarabine, Drug: Cytarabine, Drug: G-CSF, Drug: Lisaftoclax, Drug: Pelcitoclax5 cycles of the FLAG chemotherapy in combination with lisaftoclax and pelcitoclax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FludarabineGiven by IV | Drug | Comb Treatment with FLAG + Lisaftoclax (PO)+ Pelcitoclax (IV) Q4W |
| CytarabineGiven by IV | Drug | Comb Treatment with FLAG + Lisaftoclax (PO)+ Pelcitoclax (IV) Q4W |
| G-CSFGiven by Injection | Drug | Comb Treatment with FLAG + Lisaftoclax (PO)+ Pelcitoclax (IV) Q4W |
| LisaftoclaxGiven by Po | Drug | Comb Treatment with FLAG + Lisaftoclax (PO)+ Pelcitoclax (IV) Q4W |
| PelcitoclaxGiven by Iv | Drug | Comb Treatment with FLAG + Lisaftoclax (PO)+ Pelcitoclax (IV) Q4W |
Primary outcome
Safety and adverse events
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas J Short, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fludarabine, Cytarabine and G-CSF in people with Phase I and FLAG Chemotherapy, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.