Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia: a Multicenter Trial

NCT00222027 | Completed Phase 2

• 2 other identifiers: 0200701PHRC
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Several prognostic predictors, including baseline ALL features and response to initial therapy, have been described in adult ALL raising the issue of whether these predictors might be redundant and which must be considered for treatment stratification. In the GRAALL-2003 prospective Phase 2 study, we aim to hierarchize the following high-risk factors in Ph-negative ALL patients.

Conditions

Acute Lymphoblastic Leukemia

Keywords

Acute lymphoblastic leukemia; adult patient; chemotherapy; stem cell transplantation; Young adult patients

Outcome Measures

Primary Outcomes (1)

• Hierarchical evaluation of baseline poor-prognosis factors and response to initial therapy in younger adults with ALL

Secondary Outcomes (1)

• Hematologic and non hematologic toxicity of induction, consolidation and late intensification.

Interventions

Collection of treatment-stratefying prognostic factors PROCEDURE

Eligibility Criteria

• Age: 15 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years
• acute lymphoblastic leukemia newly diagnosed
• signed written informed consent

You may not qualify if:

• Lymphoblastic lymphoma
• Acute lymphoblastic leukemia 3
• Chronic Myeloid Leukemia acutisation
• Sever organ condition

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Service d'Hématologie Clinique, Hôpital Purpan

Toulouse, 31059, France

Location

Related Publications (11)

• Delafoy 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 DERIVED

• Simonin 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 DERIVED

• Balducci 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 DERIVED

• Touzart A, Boissel N, Belhocine M, Smith C, Graux C, Latiri M, Lhermitte L, Mathieu EL, Huguet F, Lamant L, Ferrier P, Ifrah N, Macintyre E, Dombret H, Asnafi V, Spicuglia S. Low level CpG island promoter methylation predicts a poor outcome in adult T-cell acute lymphoblastic leukemia. Haematologica. 2020 Jun;105(6):1575-1581. doi: 10.3324/haematol.2019.223677. Epub 2019 Sep 19.

  PMID: 31537687 DERIVED

• Bond J, Touzart A, Lepretre S, Graux C, Bargetzi M, Lhermitte L, Hypolite G, Leguay T, Hicheri Y, Guillerm G, Bilger K, Lheritier V, Hunault M, Huguet F, Chalandon Y, Ifrah N, Macintyre E, Dombret H, Asnafi V, Boissel N. DNMT3A mutation is associated with increased age and adverse outcome in adult T-cell acute lymphoblastic leukemia. Haematologica. 2019 Aug;104(8):1617-1625. doi: 10.3324/haematol.2018.197848. Epub 2019 Jan 17.

  PMID: 30655366 DERIVED

• Bond J, Marchand T, Touzart A, Cieslak A, Trinquand A, Sutton L, Radford-Weiss I, Lhermitte L, Spicuglia S, Dombret H, Macintyre E, Ifrah N, Hamel JF, Asnafi V. An early thymic precursor phenotype predicts outcome exclusively in HOXA-overexpressing adult T-cell acute lymphoblastic leukemia: a Group for Research in Adult Acute Lymphoblastic Leukemia study. Haematologica. 2016 Jun;101(6):732-40. doi: 10.3324/haematol.2015.141218. Epub 2016 Mar 4.

  PMID: 26944475 DERIVED

• Chien WW, Catallo R, Chebel A, Baranger L, Thomas X, Bene MC, Gerland LM, Schmidt A, Beldjord K, Klein N, Escoffre-Barbe M, Leguay T, Huguet F, Larosa F, Hayette S, Plesa A, Ifrah N, Dombret H, Salles G, Chassevent A, Ffrench M. The p16(INK4A)/pRb pathway and telomerase activity define a subgroup of Ph+ adult Acute Lymphoblastic Leukemia associated with inferior outcome. Leuk Res. 2015 Apr;39(4):453-61. doi: 10.1016/j.leukres.2015.01.008. Epub 2015 Jan 25.

  PMID: 25675863 DERIVED

• Dhedin N, Huynh A, Maury S, Tabrizi R, Beldjord K, Asnafi V, Thomas X, Chevallier P, Nguyen S, Coiteux V, Bourhis JH, Hichri Y, Escoffre-Barbe M, Reman O, Graux C, Chalandon Y, Blaise D, Schanz U, Lheritier V, Cahn JY, Dombret H, Ifrah N; GRAALL group. Role of allogeneic stem cell transplantation in adult patients with Ph-negative acute lymphoblastic leukemia. Blood. 2015 Apr 16;125(16):2486-96; quiz 2586. doi: 10.1182/blood-2014-09-599894. Epub 2015 Jan 13.

  PMID: 25587040 DERIVED

• Beldjord K, Chevret S, Asnafi V, Huguet F, Boulland ML, Leguay T, Thomas X, Cayuela JM, Grardel N, Chalandon Y, Boissel N, Schaefer B, Delabesse E, Cave H, Chevallier P, Buzyn A, Fest T, Reman O, Vernant JP, Lheritier V, Bene MC, Lafage M, Macintyre E, Ifrah N, Dombret H; Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL). Oncogenetics and minimal residual disease are independent outcome predictors in adult patients with acute lymphoblastic leukemia. Blood. 2014 Jun 12;123(24):3739-49. doi: 10.1182/blood-2014-01-547695. Epub 2014 Apr 16.

  PMID: 24740809 DERIVED

• Trinquand A, Tanguy-Schmidt A, Ben Abdelali R, Lambert J, Beldjord K, Lengline E, De Gunzburg N, Payet-Bornet D, Lhermitte L, Mossafa H, Lheritier V, Bond J, Huguet F, Buzyn A, Leguay T, Cahn JY, Thomas X, Chalandon Y, Delannoy A, Bonmati C, Maury S, Nadel B, Macintyre E, Ifrah N, Dombret H, Asnafi V. Toward a NOTCH1/FBXW7/RAS/PTEN-based oncogenetic risk classification of adult T-cell acute lymphoblastic leukemia: a Group for Research in Adult Acute Lymphoblastic Leukemia study. J Clin Oncol. 2013 Dec 1;31(34):4333-42. doi: 10.1200/JCO.2012.48.5292. Epub 2013 Oct 28.

  PMID: 24166518 DERIVED

• Maury S, Huguet F, Leguay T, Lacombe F, Maynadie M, Girard S, de Labarthe A, Kuhlein E, Raffoux E, Thomas X, Chevallier P, Buzyn A, Delannoy A, Chalandon Y, Vernant JP, Rousselot P, Macintyre E, Ifrah N, Dombret H, Bene MC; Group for Research on Adult Acute Lymphoblastic Leukemia. Adverse prognostic significance of CD20 expression in adults with Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia. Haematologica. 2010 Feb;95(2):324-8. doi: 10.3324/haematol.2009.010306. Epub 2009 Sep 22.

  PMID: 19773266 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Françoise HUGUET-RIGAL, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2003
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 7, 2009

Record last verified: 2009-01

Locations

FR (1)