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Study identifier: NCT06860269 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

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

Condition: Acute Lymphoblastic Leukemia  ·  Sponsor: Assistance Publique - Hôpitaux de Paris

PhasePhase 2/Phase 3
Planned participants1200
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

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About this study

Adult acute lymphoblastic leukemia (ALL) includes Ph-positive (Phpos) ALL, Ph-negative (Phneg) B-cell precursor (BCP) ALL and T-ALL/lymphoblastic lymphoma (LL), accounting for approximately 25, 50 and 25% of all cases, respectively. In younger adults, the results associated with standard therapy have markedly improved in these 3 groups, due to chemotherapy intensification in the BCP and T groups and addition of TKIs in the Phpos group, respectively. This led to reevaluate the role of allogeneic hematopoietic stem cell transplantation (HSCT) in first remission, which is generally now indicated only in higher-risk patients, mostly defined as those with persistent high levels of minimal residual disease (MRD). Nevertheless, event-free survival (EFS) remains at 60-70% at 3 years, meaning there is still room for further improvements. Fortunately, new immunotherapies have been approved to treat relapsed/refractory (R/R) BCP-ALL patients, including the anti-CD19 bispecific T-cell engager blinatumomab (BLINA, Blincyto®, Amgen). 4 BLINA is also approved for the frontline treatment of patients with persistent high measurable residual disease (MRD) levels after initial therapy (IG/TR MRD ≥0.1% (≥1.10-3 )). BLINA has been also evaluated frontline in combination with TKI in the Phpos group leading to promising outcome improvements. Toxicities associated with these combined treatments seem to be limited and manageable. In the Phpos ALL subset, the third-generation tyrosine kinase inhibit…

This description comes directly from the study's public registry record.

Talk to the study team

Nicolas Boissel, MD PhD  ·  1 42 49 96 43  ·  nicolas.boissel@aphp.fr

Jérôme Lambert, MD PhD  ·  0142499742  ·  jerome.lambert@u-paris.fr

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Locations (1)

Hôpital Saint LouisParis, FranceRecruiting

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