Actively Recruiting
A 3-cohort Randomized Study Evaluating New Immunotherapies and Stem Cell Transplantation in Frontline Treatment of Adults With Acute Lymphoblastic Leukemia
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-10
1200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adult acute lymphoblastic leukemia (ALL), including its three main types: Ph-positive ALL, Ph-negative B-cell precursor ALL, and T-ALL/lymphoblastic lymphoma. The study aims to improve frontline treatment outcomes by incorporating new antibody-based therapies and refining when allogeneic hematopoietic stem cell transplantation (HSCT) is needed in first remission. Current treatments have improved survival but there is still potential for better results, especially by reducing relapse and improving survival with new immunotherapies. The trial is a prospective, multicenter, multi-country randomized study with three cohorts based on ALL subtype: Ph-negative BCP-ALL, Ph-positive ALL, and T-ALL/LL. Treatments include standard chemotherapy, blinatumomab (an anti-CD19 antibody), ponatinib (a tyrosine kinase inhibitor), and isatuximab (an anti-CD38 antibody) depending on the cohort. Some participants receive HSCT as standard care. These treatments are given in cycles with specific dosing schedules, including intravenous infusions and oral medications, from induction through maintenance phases. Participants will be closely monitored through scheduled visits involving blood tests, measurable residual disease assessments, physical exams, and questionnaires to track treatment effects and safety. Researchers will measure outcomes such as overall survival, event-free survival, relapse rates, and quality of life over a period of up to five years. Safety and adverse events will also be recorded, with ongoing assessments to evaluate how well the new therapies work and their impact on participants' health.
CONDITIONS
Brief Title
A 3-cohort Randomized Study Evaluating the Role of New Immunotherapeutic Agents and of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Frontline Therapy of Adults With Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 65 years old
- Newly diagnosed acute lymphoblastic leukemia (ALL) or T-lymphoblastic lymphoma (T-LL) according to WHO criteria
- Immunophenotypic, cytogenetic and molecular evaluation completed to classify patient into Ph-positive ALL, Ph-negative BCP-ALL, or T-ALL/LL cohorts
- No prior treatment except corticosteroids and/or intrathecal therapy
- Eligible for allogeneic hematopoietic stem cell transplantation if Ph-positive ALL or Ph-negative BCP-ALL
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Ability and willingness to comply with study protocol, visits, and electronic reporting
- Signed written informed consent
- Women of child-bearing potential and male partners must use effective contraception during the study and for six months after
- Eligible for National Health Insurance (for French patients)
You will not qualify if you...
- Prior treatment with systemic chemotherapy, antibody therapy, or tyrosine kinase inhibitors
- History of another primary cancer requiring active treatment
- Significant central nervous system disorders such as epilepsy, stroke, severe brain injuries, dementia, or psychosis (except controlled CNS leukemia)
- Left ventricular ejection fraction below 50% or serious heart disease
- Chronic liver disease or abnormal liver function tests unless due to leukemia
- Estimated glomerular filtration rate below 50 mL/min
- Chronic or recent acute pancreatitis within 6 months
- Known HIV infection or active hepatitis B or C
- Severe concurrent medical conditions preventing treatment
- Participation in another clinical trial within 30 days
- Pregnancy or breastfeeding
- Legal guardianship or inability to comply with protocol
- Active uncontrolled infection requiring systemic treatment
- Use of prohibited medications
- Known severe allergic reactions to study drugs or their components
- Recent or planned live vaccinations
- For Ph-positive ALL patients: specific heart conduction abnormalities, history of arrhythmias, significant bradycardia, long QT syndrome or prolonged QTc interval, recent myocardial infarction, symptomatic peripheral vascular disease, recent stroke, bleeding disorders unrelated to leukemia, or gastrointestinal disorders affecting drug absorption
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 5 cycles of treatment with variable duration depending on cohort assignment and transplantation timing
Participants receive randomized frontline therapy including chemotherapy with or without immunotherapeutic agents such as Blinatumomab, Isatuximab, Ponatinib, and may undergo allogeneic hematopoietic stem cell transplantation depending on their assigned cohort.
Multiple visits corresponding to chemotherapy cycles, immunotherapy infusions, and transplantation procedures
Duration - Up to 5 years
Participants are monitored for long-term outcomes including survival, relapse, graft-versus-host disease, and adverse events for up to 5 years after treatment.
Periodic visits over 5 years for assessments
Trial Site Locations
Total: 1 location
1
Hôpital Saint Louis
Paris, France
Actively Recruiting
Research Team
N
Nicolas Boissel, MD PhD
J
Jérôme Lambert, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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