Philadelphia Chromosome Negative Adult B-cell Acute Lymphoblastic LeukemiaGRAALL-2014/BNCT02617004
Multicenter Trial Treatment of Philadelphia Chromosome Negative B-cell Acute Lymphoblastic Leukemia of Young Adults
An observational study of Philadelphia Chromosome Negative Adult B-cell Acute Lymphoblastic Leukemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Philadelphia Chromosome Negative Adult B-cell Acute Lymphoblastic Leukemia
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young Adults (age 18-59) with Philadelphia Chromosome Negative B-cell Acute Lymphoblastic Leukemia
Who may be able to join
- Whose blood and bone marrow explorations have been completed before the steroids prephase
- 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
- Whose karyotype shows no t(9;22) and/or the absence in molecular biology of breakpoint cluster region-Abelson (BCR-ABL)
- With Eastern Cooperative Oncology Group (ECOG) performance status ≤3
- With or without central nervous system (CNS) or testis involvement
- 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
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- Having signed a written informed consent
- With efficient contraception for women of childbearing age (excluding estrogens and IUD)
- With health insurance coverage
- Who have received or being receiving the steroid prephase
Who cannot join
- With lymphoblastic lymphoma and bone marrow blasts < 20%, Burkitt-type ALL, or with antecedents of chronic myeloid leukemia (CML) or other myeloproliferative neoplasm
- 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
- 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%,
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- Active severe infection or known seropositivity for HIV or human T cell leukemia/lymphoma virus type 1 (HTLV1) or active hepatitis B or C
- Pregnant (beta-Human Chorionic Gonadotropin positive) or nursing woman
- Not able to bear with the procedures or the frequency of visits planned in the trial
- Unable to consent, under tutelage or curators, or judiciary safeguard.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hématologie Adulte, Saint Louis hospital
Paris, 75010
Hervé Dombret, +33 (0)1 57 27 68 47, herve.dombret@aphp.fr
About this study
Official title: Multicenter Trial Treatment of Philadelphia Chromosome Negative (Ph-) B-lineage Acute Lymphoblastic Leukemia (ALL) of Young Adults (18-59 Years).
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS)
Measured: 4 years
Secondary outcomes (8)
Cumulative incidence of relapse (CIR)
Measured: 4 years
non relapse mortality (NMR)
Measured: 4 years
Overall survival
Measured: 4 years
Cumulative incidence of relapse (CIR) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR)
Measured: 4 years
overall survival after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR)
Measured: 4 years
Non relapse mortality (NRM) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR)
Measured: 4 years
Disease free survival (DFS) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR)
Measured: 4 years
Minimal residual disease (MRD)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Philadelphia Chromosome Negative Adult B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé Dombret, MDPhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617004
- Sponsor's protocol ID
- AOM12629_3
- Acronym
- GRAALL-2014/B
- Status last verified
- Feb 2019
- First submitted
- 25 Nov 2015
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boissel N, Huguet F, Leguay T, Hunault M, Kim R, Hicheri Y, Passet M, Chevallier P, Balsat M, Pastoret C, Delabesse E, Maury S, Thiebaut-Bertrand A, Van Obbergh F, Cluzeau T, Escoffre-Barbe M, Straetmans N, Konopacki J, Belhabri A, Villate A, Pasquier F, Vaida I, Sanhes L, Blum S, Alexis M, Lamarque M, Farnault L, Berthon C, Lheritier V, Ifrah N, Graux C, Chalandon Y, Clappier E, Dombret H. Blinatumomab consolidation for high-risk Ph- B-cell acute lymphoblastic leukemia: the GRAALL-2014/B-QUEST study. Blood. 2026 Jul 16;148(3):289-299. doi: 10.1182/blood.2026033309.
PubMed 42126414Boissel N, Chevret S, Huguet F, Leguay T, 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, Manz M, Cluzeau T, Turlure P, Rousselot P, de Prijck B, Grardel N, Bene MC, Lafage-Pochitaloff M, Cuccuini W, Ifrah N, 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. 2026 Feb 19;147(8):821-833. doi: 10.1182/blood.2025029611.
PubMed 41135009
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Trial Treatment of Philadelphia Chromosome Negative (Ph-) B-lineage Acute Lymphoblastic Leukemia (ALL) of Young Adults (18-59 Years).
- ClinicalTrials.gov ID
- NCT02617004
- Acronym / sponsor ID
- GRAALL-2014/B / AOM12629_3
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young Adults (age 18-59) with Philadelphia Chromosome Negative B-cell Acute Lymphoblastic Leukemia
Key inclusion criteria (10 listed)
- Whose blood and bone marrow explorations have been completed before the steroids prephase
- 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
- Whose karyotype shows no t(9;22) and/or the absence in molecular biology of breakpoint cluster region-Abelson (BCR-ABL)
- With Eastern Cooperative Oncology Group (ECOG) performance status ≤3
- With or without central nervous system (CNS) or testis involvement
Key exclusion criteria (10 listed)
- With lymphoblastic lymphoma and bone marrow blasts < 20%, Burkitt-type ALL, or with antecedents of chronic myeloid leukemia (CML) or other myeloproliferative neoplasm
- With contra-indication to anthracyclines or any other general or visceral contra-indication to intensive therapy except if considered related to the ALL:
- 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%,
- Active severe infection or known seropositivity for HIV or human T cell leukemia/lymphoma virus type 1 (HTLV1) or active hepatitis B or C
- Pregnant (beta-Human Chorionic Gonadotropin positive) or nursing woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease free survival (DFS)
Time frame: 4 years
8 secondary outcomes
Cumulative incidence of relapse (CIR)
Time frame: 4 years
non relapse mortality (NMR)
Time frame: 4 years
Overall survival
Time frame: 4 years
Cumulative incidence of relapse (CIR) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR)
Time frame: 4 years
overall survival after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR)
Time frame: 4 years
Non relapse mortality (NRM) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR)
Time frame: 4 years
Disease free survival (DFS) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR)
Time frame: 4 years
Minimal residual disease (MRD)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Derived from this study: PubMed 42126414Boissel N, Huguet F, Leguay T, Hunault M, Kim R, Hicheri Y, Passet M, Chevallier P, Balsat M, Pastoret C, Delabesse E, Maury S, Thiebaut-Bertrand A, Van Obbergh F, Cluzeau T, Escoffre-Barbe M, Straetmans N, Konopacki J, Belhabri A, Villate A, Pasquier F, Vaida I, Sanhes L, Blum S, Alexis M, Lamarque M, Farnault L, Berthon C, Lheritier V, Ifrah N, Graux C, Chalandon Y, Clappier E, Dombret H. Blinatumomab consolidation for high-risk Ph- B-cell acute lymphoblastic leukemia: the GRAALL-2014/B-QUEST study. Blood. 2026 Jul 16;148(3):289-299. doi: 10.1182/blood.2026033309.
- Derived from this study: PubMed 41135009Boissel N, Chevret S, Huguet F, Leguay T, 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, Manz M, Cluzeau T, Turlure P, Rousselot P, de Prijck B, Grardel N, Bene MC, Lafage-Pochitaloff M, Cuccuini W, Ifrah N, 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. 2026 Feb 19;147(8):821-833. doi: 10.1182/blood.2025029611.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hervé Dombret, MDPhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Philadelphia Chromosome Negative Adult B-cell Acute Lymphoblastic Leukemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hervé Dombret, MDPhD (+33 (0)1 57 27 68 47, herve.dombret@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02617004, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.