Clinical trial · Interventional
Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults
Young Adult With Acute Lymphoblastic Leukemia (ALL) : a Multicentric Protocol. GRAALL 2005 : T ALL or B ALL Non Ph GRAALL 2005 R : B ALL Non Ph CD20+ GRAAPH 2005 : ALL Ph
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a multicenter trial of treatment for young ALL patients. All ALL patients will receive the same steroid pre-phase in order to evaluate sensitivity or resistance. Then, patients will be included into 3 specific trials according to biological features (immunophenotype, cytogenetics, and molecular biology). Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL) 2005: * T ALL or B ALL non Ph (N=810 patients planned). * GRAALL 2005 R: B ALL non Ph CD20+ (N=220 patients planned). * GRAAPH 2005: ALL Ph+ (N=270 patients planned)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphocytic | Lymphoid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib Mesylate | Drug | Imatinib Mesylate | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Event free survival for all patients
- timeFrame
- January 2014
- measure
- GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage)
- timeFrame
- January 2014
Secondary outcomes (7)
- measure
- CR in 1 or 2 courses
- timeFrame
- January 2014
- measure
- Death in induction
- timeFrame
- January 2014
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria: * 18-59 years * ALL newly diagnosed (blast \< 20%) * Central Nervous System (CNS) positive or negative * Signed written informed consent * For GRAAPH trial only: t(9;22) or BCR- ABL positive Exclusion Criteria: * Lymphoblastic lymphoma * ALL 3 * Chronic myeloid leukemia * Severe organ condition
References
Publications (16)
- DERIVEDPinton A, Courtois L, Delafoy M, Bonnet M, Cieslak A, Lhermitte L, Simonin M, Dourthe ME, Touzart A, Andrieu GP, Dombret H, Baruchel A, Spicuglia S, Payet-Bornet D, Boissel N, Macintyre E, Asnafi V. Homeodomain-driven oncogenic diversion to a gammadeltaTCR phenotype in T-cell acute lymphoblastic leukemia. Blood. 2026 Jun 4;147(23):2793-2808. doi: 10.1182/blood.2025030626. PMID 41592282
- DERIVEDDelafoy M, Bonnet MF, Lengline E, Cieslak A, Touzart A, Balducci E, Simonin M, Lheritier V, Dourthe ME, Heid-Picard B, Latour S, Dombret H, Rousselot P, Baruchel A, Boissel N, Andrieu GP, Asnafi V. LEF1 intragenic deletion induces a dominant-negative isoform and unveils a Wnt/beta-catenin vulnerability in T-ALL. Blood. 2025 Dec 18;146(25):3036-3049. doi: 10.1182/blood.2025030161. PMID 40857670
- DERIVEDSimonin M, Vasseur L, Lengline E, Lhermitte L, Cabannes-Hamy A, Balsat M, Schmidt A, Dourthe ME, Touzart A, Graux C, Grardel N, Cayuela JM, Arnoux I, Gandemer V, Huguet F, Ducassou S, Lheritier V, Chalandon Y, Ifrah N, Dombret H, Macintyre E, Petit A, Rousselot P, Lambert J, Baruchel A, Boissel N, Asnafi V. NGS-based stratification refines the risk stratification in T-ALL and identifies a very-high-risk subgroup of patients. Blood. 2024 Oct 10;144(15):1570-1580. doi: 10.1182/blood.2023023754. PMID 38848537
- DERIVEDBalducci E, Simonin M, Duployez N, Steimle T, Dourthe ME, Villarese P, Ducassou S, Arnoux I, Cayuela JM, Balsat M, Courtois L, Andrieu G, Touzart A, Huguet F, Petit A, Ifrah N, Dombret H, Baruchel A, Macintyre E, Preudhomme C, Boissel N, Asnafi V. Genomic imbalance analysis provides new insight into prognostic factors in adult and pediatric T-ALL. Blood. 2024 Aug 29;144(9):988-1000. doi: 10.1182/blood.2023022154. PMID 38518104
- DERIVEDOrvain C, Balsat M, Tavernier E, Marolleau JP, Pabst T, Chevallier P, de Gunzburg N, Cacheux V, Huguet F, Chantepie S, Caillot D, Chalandon Y, Frayfer J, Bonmati C, Lheritier V, Ifrah N, Dombret H, Boissel N, Hunault-Berger M. Thromboembolism prophylaxis in adult patients with acute lymphoblastic leukemia treated in the GRAALL-2005 study. Blood. 2020 Jul 16;136(3):328-338. doi: 10.1182/blood.2020004919.