BridgeMD
A PRECISION MEDICINE RANDOMIZED TRIAL FOR PATIENTS WITH RELAPSED OR REFRACTORY T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA BASED ON A FUNCTIONAL APPROACH. ALL-TARGET TRIAL
EU CTIS ID: 2024-516570-30-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- Patients in palliative care.
- Administration of live or live-attenuated vaccines within 4 weeks prior to the first dose of study treatment (see Annex 13.10)
- Subject presenting with psychiatric disorders or any other condition that impair their ability to cooperate with study procedures.
- 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.
See the full eligibility criteria
Who can join
- 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).
What rules you out
- Patients in palliative care.
- Administration of live or live-attenuated vaccines within 4 weeks prior to the first dose of study treatment (see Annex 13.10)
- Subject presenting with psychiatric disorders or any other condition that impair their ability to cooperate with study procedures.
- 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.
- Participation in another clinical trial with an investigative drug at the time of study enrolment.
- Individuals with another active uncontrolled malignancy.
- Known active HBV-, HCV and HIV related diseases.
- Patient under curatorship or deprived of liberty (except for minors).
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.