Could new immune drugs replace transplants for leukemia patients?
NCT ID NCT06860269
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding newer antibody-based drugs to standard chemotherapy can improve survival and reduce the need for stem cell transplants in adults with acute lymphoblastic leukemia (ALL). About 1,200 patients aged 18–65 with newly diagnosed ALL will be assigned to one of three groups based on their leukemia subtype. The goal is to see if these newer treatments can control the disease better than current approaches.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 1,200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Mar 2035
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients aged 18 to 65 years old 2. Newly diagnosed ALL or T-LL according to the WHO criteria 3. Immunophenotypic, cytogenetic and/or FISH and molecular evaluation performed and allowing classifying the patient in one of the Phpos ALL, Phneg BCP-ALL or T-ALL/LL cohorts 4. Not previously treated except with corticosteroids and/or intrathecal therapy (prephase) 5. Eligible for allo-HSCT if Phpos ALL or Phneg BCP-ALL 6. ECOG performance status ≤2 7. Patient willing and able to understand the protocol requirements and comply with the treatment schedule, scheduled visits, electronic patient outcome reporting, exams and other requirements of the study 8. Patients has signed written inform consent 9. Willingness of women of child-bearing potential (WOCBP) and male subjects whose sexual partners are WOCBP to use an effective form of contraception, i.e. methods with a failure rate of \<1% per year when used consistently and correctly, during the study and at least 6 months thereafter 10. Eligible for National Health Insurance (for French patients) Exclusion Criteria: Common exclusion criteria : 1. Patient previously treated with systemic chemotherapy, antibody-based therapy or TKI 2. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention 3. History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, coordination/movement disorder, autoimmune disease with CNS involvement, psychosis (with the exception of CNS leukemia that is well controlled with intrathecal therapy) 4. Patients with LVEF\<50% or other clinically significant heart disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension) 5. Prior documented chronic liver disease. Inadequate hepatic functions defined as AST or ALT \> 5 x the institutional upper limit of normal (ULN), or \> 5 x ULN unless if considered due to leukemia. Total bilirubin \> 1.5 x ULN unless if considered due to leukemia or Gilbert/Meulengracht 6. Estimated glomerular filtration rate (GFR) \< 50 mL/mn using the MDRD equation 7. Chronic pancreatitis or acute pancreatitis within 6 months before study start 8. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) or active infection with Hepatitis B or C. 9. Concurrent severe diseases which exclude the administration of therapy 10. Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study 11. Pregnancy and breast feeding 12. Patients unwilling or unable to comply with the protocol 13. Patients under a legal protection regime (guardianship, trusteeship, judicial safeguard) 14. Chronic or current active uncontrolled infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment 15. Current use of prohibited medication 16. Known hypersensitivity or severe reaction to ponatinib (GRAAPH), blinatumomab (GRAAPH and GRAALL-B) , isatuximab (GRAALL-T) or their excipients. 17. Receipt of live (including attenuated) vaccines or anticipation of need for such vaccines during the study If patients with Phpos ALL: 1. Complete left bundle branch block, right bundle branch block plus left anterior hemiblock, bi-fascicular block 2. History of or presence of clinically significant ventricular or atrial tachyarrhythmias 3. Clinically significant resting bradycardia (\< 50 beats per minute) 4. Congenital long QT syndrome or QTcF \> 470 msec on screening ECG. If QTc \> 470 msec and electrolytes are not within normal ranges before ponatinib dosing, electrolytes should be corrected and then the patient rescreened for QTcF criterion 5. Currently taking drug(s) that are known to have a risk of causing prolonged QTc or TdP unless the drug(s) can be changed to acceptable alternatives (ie, an alternate class of agents that do not affect the cardiac conduction system), or the participant can safely discontinue the drug(s) 6. Previous myocardial infarction within the last 12 months 7. Symptomatic peripheral vascular disease 8. History of ischemic stroke or transient ischemic attacks (TIAs) within the last 12 months 9. Significant bleeding disorder or thrombophilia unrelated to the underlying malignancy indication for study participation 10. Gastrointestinal disorders, such as malabsorption syndrome or any other illness that could affect oral absorption
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hôpital Saint Louis
RECRUITINGParis, France
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