A Precision Medicine Trial for Patients With Relapsed or Refractory T Cell ALL (ALL-TARGET)

April 16, 2026 updated by: Philippe ROUSSELOT

A Precision Medicine Randomized Trial for Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemian Based on a Functional Approach

To evaluate the benefit of a precision medicine based strategy (targeted therapeutic options (TTOs)) for patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) (in terms of composite remission).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

93

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients aged 15y or more (under 18y only for France)
  2. Signed informed consent for patients aged ≥ 18 years and signed informed consent from both parents for patients aged between ≥ 15 years and < 18 years (only for France).

  3. Patients with T-cell acute lymphoblastic leukemia in first or second relapse or in the refractory phase.

    1. Patients with first relapses are eligible if relapse occurred within 24 months post complete remission achievement and if nelarabine is not considered as appropriate salvage therapy.
    2. Patients with second and all subsequent relapses are eligible.
    3. Refractory patients are defined as patients not responding after at least 2 lines of chemotherapy (induction + salvage).
    4. Patients with relapses post-transplant and post CART-cells treatments are eligible.
  4. Blast cells in blood and/or bone marrow to allow the shipment to one of the 3 reference laboratories in France, Spain and The Netherlands or An informative biological assessment already performed within 10 days prior to inclusion in one of the three reference laboratories in France, Spain or The Netherlands with at least one targeted therapeutic option validated (TTO1, venetoclax + tofacitinib; TTO2, venetoclax+ everolimus + enrylaze; TTO3, venetoclax + 5-azacytidine) by one of the three National Validation Committees.
  5. Adequate ECOG score (0-3).
  6. Patients must be affiliated to a National Health systems (see country-based specificity).
  7. Patients must not have a contra-indication for venetoclax, tofacitinib, everolimus, glutaminolytic agents (enrylaze) or 5-azacytidine.
  8. Willingness of women of child-bearing potential (WOCBP) or of male patients whose sexual partners are WOCBP to use an effective form of contraception during the study and at least 6 months thereafter.

Exclusion Criteria:

  1. Patients in palliative care.
  2. Patients with late relapses after the first complete remission (> 24 months post complete remission).
  3. Patients with extramedullary only relapses or with clinically symptomatic central nervous system (CNS) involvement.
  4. Pregnant or lactating women.
  5. Participation in another clinical trial with an investigative drug at the time of study enrolment.
  6. Individuals with another active uncontrolled malignancy.
  7. Known active HBV-, HCV and HIV related diseases.
  8. Patient under curatorship or deprived of liberty (except for minors).

  9. Patients with contra-indication to chemotherapy except if considered related to the ALL:

    • ASAT (SGOT) and/or ALAT (SGPT) > 5 x ULN
    • Total bilirubin ≥ 2.5 x ULN
    • Estimated glomerular filtration rate (GFR) < 50 mL/mn using the MDRD equation

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TTO1 Venetoclax + Tofacitinib
Drug: Venetoclax + Tofacitinib

Cycle 1:

Venetoclax, 100 mg/d PO day1; 200 mg/d day2; 300 mg/d day3 and 400 mg/day thereafter (100 mg/day in case of concomitant administration of azoles) Tofacitinib, 10 mg BID PO started from day 5

Cycle 2 and 3 (4, 5 and 6 if applicable):

Venetoclax, 400 mg/day PO (100 mg/day in case of concomitant administration of azoles) Tofacitinib, 10 mg BID PO
Experimental: TTO2 Venetoclax + Everolimus + Enrylaze
Drug: Venetoclax+ Everoliumus +Enrylaze

Cycle 1:

Venetoclax, 100 mg/d PO day1; 200 mg/d day2; 300 mg/d day3 and 400 mg/day thereafter (100 mg/day in case of concomitant administration of azoles)

Everolimus, 5 mg/day orally continuously. Everolimus must be administered at least 6 hours after venetoclax.

Enrylaze 25 mg/m2 intravenously at day1, 3, 5, 7 (half dose for patients >50 years)

Cycle 2 and 3 (4, 5 and 6 if applicable):

Venetoclax, 400 mg/day PO (100 mg/day in case of concomitant administration of azoles)

Everolimus, 5 mg/day orally continuously (based on tolerance, in the absence of related AE > 1, everolimus daily dose can be increased to 10 mg/d). Everolimus must be administered at least 6 hours after venetoclax.

Enrylaze 25 mg/m2 intravenously at day1, 3, 5, 7 (half dose for patients >50 years)
Experimental: TTO3 Venetoclax + 5 Azacitidine
Drug: Venetoclax + 5 Azacitidine

Cycle 1:

Venetoclax, 100 mg/day PO day1; 200 mg/d day2; 300 mg/d day3 and 400 mg/day thereafter (100 mg/d in case of concomitant administration of azoles) 5-azacytidine, 75 mg/m² sub cut QD started from day5 to day10

Cycle 2 and 3 (4, 5 and 6 if applicable):

Venetoclax, PO 400 mg/day (100 mg/day in case of concomitant administration of azoles) 5-azacytidine, 75 mg/m² sub cut QD started from day1 to day7
Active Comparator: SOC Regular chemotherapy
Drug: Venetoclax + Tofacitinib

Cycle 1:

Venetoclax, 100 mg/d PO day1; 200 mg/d day2; 300 mg/d day3 and 400 mg/day thereafter (100 mg/day in case of concomitant administration of azoles) Tofacitinib, 10 mg BID PO started from day 5

Cycle 2 and 3 (4, 5 and 6 if applicable):

Venetoclax, 400 mg/day PO (100 mg/day in case of concomitant administration of azoles) Tofacitinib, 10 mg BID PO

Drug: Venetoclax+ Everoliumus +Enrylaze

Cycle 1:

Venetoclax, 100 mg/d PO day1; 200 mg/d day2; 300 mg/d day3 and 400 mg/day thereafter (100 mg/day in case of concomitant administration of azoles)

Everolimus, 5 mg/day orally continuously. Everolimus must be administered at least 6 hours after venetoclax.

Enrylaze 25 mg/m2 intravenously at day1, 3, 5, 7 (half dose for patients >50 years)

Cycle 2 and 3 (4, 5 and 6 if applicable):

Venetoclax, 400 mg/day PO (100 mg/day in case of concomitant administration of azoles)

Everolimus, 5 mg/day orally continuously (based on tolerance, in the absence of related AE > 1, everolimus daily dose can be increased to 10 mg/d). Everolimus must be administered at least 6 hours after venetoclax.

Enrylaze 25 mg/m2 intravenously at day1, 3, 5, 7 (half dose for patients >50 years)

Drug: Venetoclax + 5 Azacitidine

Cycle 1:

Venetoclax, 100 mg/day PO day1; 200 mg/d day2; 300 mg/d day3 and 400 mg/day thereafter (100 mg/d in case of concomitant administration of azoles) 5-azacytidine, 75 mg/m² sub cut QD started from day5 to day10

Cycle 2 and 3 (4, 5 and 6 if applicable):

Venetoclax, PO 400 mg/day (100 mg/day in case of concomitant administration of azoles) 5-azacytidine, 75 mg/m² sub cut QD started from day1 to day7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission rate
Time Frame: 3 months
Composite Complete Remission (CRc) rate defined as complete remission (CR) and remission without complete hematological recovery (CRi) by 3 months post-randomization.
3 months

Collaborators and Investigators

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

Sponsor

Philippe ROUSSELOT

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 (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

April 4, 2026

First Submitted That Met QC Criteria

April 4, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P23/15_All Target
  • 2024-516570-30-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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