Multicenter Trial Treatment of Philadelphia Chromosome Negative B-cell Acute Lymphoblastic Leukemia of Young Adults

NCT ID: NCT02617004

Last Updated: 2019-02-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2025-12-31

Brief Summary

The purpose of this study is to prospectively validate the new risk model, based on minimal residual disease (MRD) response level and oncogenetic status by comparing historical results of GRAALL-2005 with those of GRAALL-2014 in an identical population of patients (Philadelphia chromosome negative, B lineage ALL, aged 18 to 59 years old).

Conditions

Philadelphia Chromosome Negative Adult B-cell Acute Lymphoblastic Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Whose blood and bone marrow explorations have been completed before the steroids prephase

2. Aged 18 to 59 years old with not previously treated (including intrathecal injection) B-lineage-ALL newly diagnosed according to the WHO 2008 definition with ≥ 20% bone marrow blasts

3. Whose karyotype shows no t(9;22) and/or the absence in molecular biology of breakpoint cluster region-Abelson (BCR-ABL)

4. With Eastern Cooperative Oncology Group (ECOG) performance status ≤3

5. With or without central nervous system (CNS) or testis involvement

6. Without other evolving cancer (except basal cell carcinoma of the skin or "in situ" carcinoma of the cervix) or its radiotherapy or chemotherapy treatment should be finished at least since 6 months

7. Having signed a written informed consent

8. With efficient contraception for women of childbearing age (excluding estrogens and IUD)

9. With health insurance coverage

10. Who have received or being receiving the steroid prephase

Exclusion Criteria

1. With lymphoblastic lymphoma and bone marrow blasts < 20%, Burkitt-type ALL, or with antecedents of chronic myeloid leukemia (CML) or other myeloproliferative neoplasm

2. With contra-indication to anthracyclines or any other general or visceral contra-indication to intensive therapy except if considered related to the ALL:

• Aspartate transaminase (AST) and/or alanine transaminase (ALT) > 5 x upper limit of normal range (ULN)
• Total bilirubin ≥ 2.5 x upper limit of normal range (ULN)
• Creatinine >1.5x upper limit of normal range (ULN) or creatinine clearance <50 mL/mn

3. Myocardial infarction within 6 months prior to inclusion in the trial, cardiomyopathy (NYHA grade III or IV), left ventricle ejection fraction (LVEF) < 50% and or Shortening fraction < 30%,

4. Active severe infection or known seropositivity for HIV or human T cell leukemia/lymphoma virus type 1 (HTLV1) or active hepatitis B or C

5. Pregnant (beta-Human Chorionic Gonadotropin positive) or nursing woman

6. Not able to bear with the procedures or the frequency of visits planned in the trial

7. Unable to consent, under tutelage or curators, or judiciary safeguard.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hervé Dombret, MDPhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Hématologie Adulte, Saint Louis hospital

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Hervé Dombret, MDPhD

Role: CONTACT

herve.dombret@aphp.fr

+33 (0)1 57 27 68 47

Véronique Lhéritier

Role: CONTACT

veronique.lheritier@chu-lyon.fr

+33(0)4 78 86 22 39

Facility Contacts

Hervé Dombret

Role: primary

herve.dombret@aphp.fr

+33 (0)1 57 27 68 47

References

Boissel N, Chevret S, Rigal-Huguet F, Leguay TT, Hunault M, Graux C, Chalandon Y, Delabesse E, Hicheri Y, Chevallier P, Balsat M, Pastoret C, Escoffre-Barbe M, Pasquier F, Joris M, Thiebaut A, Huynh A, Dhedin N, Lemasle E, Bonmati C, Maury S, Guillerm G, Berceanu A, Schanz U, Cluzeau T, Turlure P, Rousselot P, De Prijck B, Grardel N, Bene MC, Lafage-Pochitaloff M, Cuccuini W, Ifrah NH, Lheritier V, Asnafi V, Clappier E, Dombret H. Age-adapted chemotherapy and MRD-oriented transplant for Ph-negative acute lymphoblastic leukemia: the GRAALL-2014 trial. Blood. 2025 Oct 24:blood.2025029611. doi: 10.1182/blood.2025029611. Online ahead of print.

Reference Type: DERIVED

PMID: 41135009 (View on PubMed)

Other Identifiers

AOM12629_3

Identifier Type: -

Identifier Source: org_study_id