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Leukemia, LymphocyticPhase 3NCT00327678

Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults

A Phase 3 study testing Rituximab and Imatinib Mesylate in people with Leukemia, Lymphocytic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 59 years
Conditions the study is for
Leukemia, Lymphocytic
What is being tested?
Rituximab and Imatinib Mesylate
How many people
1,080 participants
Where
1 siteFrance
Study dates
May 2006to Apr 2014
Phase
Phase 3
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

Who may be able to join

  • 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

Who cannot join

  • Lymphoblastic lymphoma
  • ALL 3
  • Chronic myeloid leukemia
  • Severe organ condition

Trial locations and contacts

1 site in 1 country.

France1 site

  • Group for Research in Adult Acute Lymphoblastic Leukemia - GRAALL -

    Lyon, 69

Other trials in France

About this study

Official title: 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

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)
Read the detailed description

GRAALL 2005: T ALL or B ALL non Ph

Randomization between standard versus intensified cyclophosphamide administration during a 4-drug, 4 week chemotherapy and late intensification.

(N=810 patients planned)

GRAALL 2005 R: B ALL non Ph CD20+

Randomization between standard versus intensified cyclophosphamide administration during a 4-drug, 4 week chemotherapy and late intensification.

Randomization between Mabthera (rituximab) or no Mabthera during all induction and consolidation courses.(N=220 patients planned)

Allogenic transplantation will be performed depending on unfavourable risk factors.

GRAAPH 2005: ALL Ph

Randomization between an imatinib-based induction and a chemotherapy + imatinib induction. (N=270 patients planned)

Allogenic transplantation will be systematically performed in the presence of related or unrelated donors.

Autologous transplantation could be performed in the absence of a donor in case of Molecular Residual Disease (MRD) ≤ 10-4.

Consolidation therapy will be performed in the absence of a donor in case of MRD > 10-4.

Being tested
Rituximab, Imatinib Mesylate
Keywords
ALL,, young patients,, chemotherapy,, Mabtera,, Imatinib,, allogeneic transplant
Medical subject headings
Leukemia, Lymphoid

What participants receive

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

What is being measured

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

  1. Event free survival for all patients

    Measured: January 2014

  2. GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage)

    Measured: January 2014

Secondary outcomes (7)

  1. CR in 1 or 2 courses

    Measured: January 2014

  2. Death in induction

    Measured: January 2014

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: January 2014

  4. Death in first CR

    Measured: January 2014

  5. Relapse

    Measured: January 2014

  6. Relapse free survival

    Measured: January 2014

  7. Overall Survival

    Measured: January 2014

Timeline

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

  1. First posted18 May 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionApr 2014
  4. Study completionApr 2014

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,080 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00327678
Sponsor's protocol ID
GRAALL 2005
Status last verified
Mar 2016
First submitted
16 May 2006
Last updated
27 Jun 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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

  • 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.

    PubMed 40857670

  • 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.

    PubMed 38848537

  • 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.

    PubMed 38518104

  • Orvain 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.

    PubMed 32321172

  • 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.

    PubMed 31537687

  • 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.

    PubMed 30655366

  • Huguet F, Chevret S, Leguay T, Thomas X, Boissel N, Escoffre-Barbe M, Chevallier P, Hunault M, Vey N, Bonmati C, Lepretre S, Marolleau JP, Pabst T, Rousselot P, Buzyn A, Cahn JY, Lheritier V, Bene MC, Asnafi V, Delabesse E, Macintyre E, Chalandon Y, Ifrah N, Dombret H; Group of Research on Adult ALL (GRAALL). Intensified Therapy of Acute Lymphoblastic Leukemia in Adults: Report of the Randomized GRAALL-2005 Clinical Trial. J Clin Oncol. 2018 Aug 20;36(24):2514-2523. doi: 10.1200/JCO.2017.76.8192. Epub 2018 Jun 4.

    PubMed 29863974

  • Maury S, Chevret S, Thomas X, Heim D, Leguay T, Huguet F, Chevallier P, Hunault M, Boissel N, Escoffre-Barbe M, Hess U, Vey N, Pignon JM, Braun T, Marolleau JP, Cahn JY, Chalandon Y, Lheritier V, Beldjord K, Bene MC, Ifrah N, Dombret H; for GRAALL. Rituximab in B-Lineage Adult Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Sep 15;375(11):1044-53. doi: 10.1056/NEJMoa1605085.

    PubMed 27626518

  • 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.

    PubMed 26944475

  • Chalandon Y, Thomas X, Hayette S, Cayuela JM, Abbal C, Huguet F, Raffoux E, Leguay T, Rousselot P, Lepretre S, Escoffre-Barbe M, Maury S, Berthon C, Tavernier E, Lambert JF, Lafage-Pochitaloff M, Lheritier V, Chevret S, Ifrah N, Dombret H; Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL). Randomized study of reduced-intensity chemotherapy combined with imatinib in adults with Ph-positive acute lymphoblastic leukemia. Blood. 2015 Jun 11;125(24):3711-9. doi: 10.1182/blood-2015-02-627935. Epub 2015 Apr 15.

    PubMed 25878120

  • 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.

    PubMed 25675863

  • 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.

    PubMed 25587040

  • 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.

    PubMed 24740809

  • 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.

    PubMed 24166518

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab and Imatinib Mesylate in people with Leukemia, Lymphocytic, 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 27 Jun 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Event free survival for all patients (time frame: January 2014). The study lists 2 primary outcomes in all. 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 NCT00327678, which also lists 16 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 27 Jun 2016.

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