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Not yet taking people in GermanyPhase 2

Targeted drug combinations for T-cell acute lymphoblastic leukemia that returned or did not respond

Tests targeted drug combinations in people whose T-cell acute lymphoblastic leukemia relapsed or resisted treatment.

Key facts

Who runs it
Centre Hospitalier De Versailles
Where
Frankfurt Am Main, GermanySee the siteAlso in 4 other countries, 66 sites
Registry title
A PRECISION MEDICINE RANDOMIZED TRIAL FOR PATIENTS WITH RELAPSED OR REFRACTORY T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA BASED ON A FUNCTIONAL APPROACH. ALL-TARGET TRIAL
Status
Not yet recruiting
Phase
Phase 2
People taking part
86 people, planned
Started
1 Jun 2026
Expected to end
1 Jan 2030
Type of study
Interventional
Record updated
8 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 15 or older with T-cell acute lymphoblastic leukemia that came back (first or second relapse) or did not respond to treatment.

Age
15 years or older (in France, people under 18 need both parents to sign consent).
Sex
All sexes can join.
Disease stage
T-cell acute lymphoblastic leukemia in first or second relapse, or refractory. A first relapse counts only if it came within 24 months after complete remission and nelarabine is not seen as a good option. Later relapses can join. Refractory means no response after at least 2 lines of chemotherapy. Relapse after transplant or CAR-T cells can join.
Earlier treatment
Refractory patients must have had at least 2 lines of chemotherapy. Relapse after transplant or CAR-T cell treatment is allowed. No live or live-attenuated vaccine in the 4 weeks before the first dose of study treatment.
Biomarker or test result
Blast cells in blood or bone marrow must be sent to one of 3 reference laboratories (France, Spain, The Netherlands), or a recent test done within 10 days before inclusion. At least one targeted treatment option must be validated by a national committee.

Main reasons for not taking part

  • Late relapse more than 24 months after complete remission
  • Relapse outside the bone marrow only, or symptomatic central nervous system involvement
  • Pregnant or breastfeeding women
  • Known active HBV, HCV or HIV disease
  • Another active uncontrolled cancer, or taking part in another trial with an investigational drug

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • Patients aged 15y or more (under 18y only for France)
  • 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)
  • Patients with T-cell acute lymphoblastic leukemia in first or second relapse or in the refractory phase. a) 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. b) Patients with second and all subsequent relapses are eligible. c) Refractory patients are defined as patients not responding after at least 2 lines of chemotherapy (induction + salvage). d) Patients with relapses post-transplant and post CART-cells treatments are eligible
  • 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
  • Adequate ECOG score (0-3)
  • Patients must be affiliated to a National Health systems (see country-based specificity)
  • Patients must not have a contra-indication for venetoclax, tofacitinib, everolimus, glutaminolytic agents (enrylaze) or 5-azacytidine
  • 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 3 months thereafter (see Annex 13.9)

Who cannot take part

  • Administration of live or live-attenuated vaccines within 4 weeks prior to the first dose of study treatment (see Annex 13.10)
  • Participation in another clinical trial with an investigative drug at the time of study enrolment
  • Subject presenting with psychiatric disorders or any other condition that impair their ability to cooperate with study procedures
  • Individuals with another active uncontrolled malignancy
  • Known active HBV-, HCV and HIV related diseases
  • 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
  • Patients in palliative care
  • Patients with late relapses after the first complete remission (> 24 months post complete remission)
  • Patients with extramedullary only relapses or with clinically symptomatic central nervous system (CNS) involvement
  • Pregnant or lactating women
  • Patient under curatorship or deprived of liberty (except for minors)

Where in Germany

Also in 4 other countries, 66 sites

  • Goethe University FrankfurtFrankfurt Am Main, GermanyNot yet recruiting

About the trial

What the trial wants to find out

Evaluer le bénéfice d’une stratégie basée sur la médecine de précision (combinaisons de traitements ciblés (CTC)) sur le taux de réponse hématologique chez des patients atteints de leucémie aiguë lymphoblastique T en rechute ou réfractaire.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A PRECISION MEDICINE RANDOMIZED TRIAL FOR PATIENTS WITH RELAPSED OR REFRACTORY T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA BASED ON A FUNCTIONAL APPROACH. ALL-TARGET TRIAL
Plain-language title
Targeted drug combinations for T-cell acute lymphoblastic leukemia that returned or did not respondGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
8 June 2026