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Acute Lymphoblastic Leukemia, Adult B-CellPhase 2GRAALL-QUESTNCT03709719

Blinatumomab in High-risk B-cell Precursor Acute Lymphoblastic Leukemia

A Phase 2 study testing Blinatumomab Injection in people with Acute Lymphoblastic Leukemia, Adult B-Cell, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The GRAALL-QUEST study is a Phase 2 study nested in the GRAALL-2014/B study (NCT02617004). The GRAALL-QUEST study evaluates the safety and the efficacy of blinatumomab-containing consolidation and maintenance therapy in patients aged 18-59 years old with high-risk B-cell precursor acute lymphoblastic leukemia… Read more about this study

Who is it for?
Ages 18 to 59 years
What is being tested?
Blinatumomab Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteFrance
Study dates
20 Oct 2018to 30 Oct 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Included in GRAALL-2014/B
  • Whose blood and bone marrow explorations have been completed before the steroids prephase
  • Aged 18 to 59 years old with not previously treated B-lineage-ALL (including intrathecal injections) 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 BCR-ABL marker
  • With Eastern Cooperative Oncology Group (ECOG) performance status < 3
  • With or without central nervous system (CNS) or testis involvement
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  • Without other evolving cancer (except basal cell carcinoma of the skin or "in situ" carcinoma of the cervix) or its treatment should be finished at least since 6 months
  • Having signed a written informed consent
  • With efficient contraception for women of childbearing age (excluding estrogens and IUS)
  • With health insurance coverage
  • Who have received or being receiving the steroid prephase
  • With High Risk (HR) B-ALL
  • ECOG ≤ 3
  • In Complete Remission after one or two induction cures and having received the three blocks of consolidation N°1
  • With or without allogeneic donor

Who cannot join

  • With ECOG status > 3 after consolidation 1
  • With abnormal laboratory values as defined below after consolidation 1
  • Aspartate transaminase (AST) (SGOT) and/or alanine transaminase (ALT) (SGPT) ≥ 5 x ULN
  • Total bilirubin ≥ 1.5 x ULN
  • Creatinine ≥ 1.5 x ULN or creatinine clearance < 50 ml/min
  • Serum amylase and lipase ≥ 1.5 x ULN
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  • With active uncontrolled infection, any other concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator
  • New York Heart Association (NYHA) Functional Classification 3-4 cardiac disease
  • Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hopital saint Louis

    Paris, 75010

Other trials in France

About this study

Official title: A Phase II Study to Evaluate the Safety and the Efficacy of a Blinatumomab Based Consolidation and Maintenance in Patients With High-risk B-cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL). GRAALL-QUEST

The GRAALL-QUEST study is a Phase 2 study nested in the GRAALL-2014/B study (NCT02617004). The GRAALL-QUEST study evaluates the safety and the efficacy of blinatumomab-containing consolidation and maintenance therapy in patients aged 18-59 years old with high-risk B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in first complete hematologic remission after one induction course of standard chemotherapy and no central nervous system (CNS) involvement at diagnosis.

High-risk patients are defined as patients with KMT2A/MLL gene rearrangement, and/or IKZF1 (Ikaros) intra-genic deletion and/or high post-induction Ig-TCR minimal residual disease (MRD) level (≥10-4). In such patients not receiving blinatumomab, 3-year hematologic relapse incidence and relapse-free survival (RFS) are estimated at 60-65% and 50% only, respectively, on the basis of historical results.

A large subset of these high-risk patients (i.e. those with post-induction MRD level ≥10-3 and/or post-consolidation MRD level ≥10-4), but not all, will also be considered as candidates for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in first hematologic remission. The primary objective of the GRAALL-QUEST study is to evaluate the efficacy of adding blinatumomab to consolidation and eventually maintenance therapy in term of Relapse Free Survival (RFS). Secondary objectives are overall survival, comparison of RFS and Overall Survival (OS) in transplanted versus non-transplanted patients, MRD response and safety. Blinatumomab will be given as monthly cycles at the daily dose of 28 microg/d continuous IV infusion, together with 3 triple intra-thecal (IT) chemotherapy injections. The first cycle will start after completion of the first consolidation chemotherapy phase (corresponding to the MRD2 time-point). Patients receiving allo-HSCT will receive successive blinatumomab cycles until allo-HSCT. Patients not receiving allo-HSCT will receive a first blinatumomab cycle (cycle 1) during the second consolidation chemotherapy phase, followed by late intensification, then the third consolidation chemotherapy phase including another blinatumomab cycle (cycle 2) and maintenance chemotherapy including three additional blinatumomab cycles (cycles 3 to 5), for a total of 5 blinatumomab cycles maximum.

Being tested
Blinatumomab Injection
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blinatumomab InjectionDrug

    Blinatumomab 28 μg/day : D1 to D28

Study groups in NCT03709719
Study groupRoleWhat they receive
blinatumomabExperimentalNot described
Receives: Drug: Blinatumomab Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Free Survival Y3

    Disease Free Survival at 3 years

    Measured: 3 years

Secondary outcomes (7)

  1. OS Y3

    Overall survival at 3 years

    Measured: 3 years

  2. CIR Y3

    Cumulative incidence of relapse at 3 years

    Measured: 3 years

  3. NRM

    Non Relapse related Mortality

    Measured: 3 years

  4. MRD1

    Minimal Residual Disease

    Measured: after induction or on day 1 of first consolidation

  5. MRD2

    Minimal Residual Disease

    Measured: on day 1 of second consolidation

  6. MRD3

    Minimal Residual Disease

    Measured: on day 1 of late intensification(or at pre Allo-SCT evaluation)

  7. MRD4

    Minimal Residual Disease

    Measured: on day 1 of maintenance phase (or at day 100 after Allo-SCT)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2018
  2. Study start20 Oct 2018
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
95 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03709719
Sponsor's protocol ID
GRAALL-QUEST
Acronym
GRAALL-QUEST
Status last verified
Apr 2021
First submitted
15 Oct 2018
Last updated
3 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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 42126414

  • Pinton 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.

    PubMed 41592282

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Blinatumomab Injection in people with Acute Lymphoblastic Leukemia, Adult B-Cell, 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 15 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 3 May 2021. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival Y3 (time frame: 3 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 NCT03709719, 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 3 May 2021.

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