A Phase 1 Study Of FLAG Chemotherapy In Combination With Lisaftoclax And Pelcitoclax In Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia

May 1, 2026 updated by: M.D. Anderson Cancer Center
To find safe and effective doses of lisaftoclax and pelcitoclax in combination with FLAG chemotherapy in patients with relapsed/refractory T-ALL.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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:

    1. Total serum bilirubin <2x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI
    2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <3 x ULN, unless due to the underlying leukemia approved by the PI
    3. Creatinine clearance ≥30 mL/min
    4. 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.

Exclusion Criteria

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comb Treatment with FLAG + Lisaftoclax (PO)+ Pelcitoclax (IV) Q4W
5 cycles of the FLAG chemotherapy in combination with lisaftoclax and pelcitoclax
Drug: Fludarabine
Given by IV
Drug: Cytarabine
Given by IV
Drug: G-CSF
Given by Injection
Drug: Lisaftoclax
Given by Po
Drug: Pelcitoclax
Given by Iv

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Ascentage Pharma Group Inc.

Investigators

  • Principal Investigator: Nicholas J Short, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2026

Primary Completion (Actual)

April 27, 2026

Study Completion (Actual)

April 27, 2026

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-1676
  • NCI-2026-01274 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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