T-cell Adult Acute Lymphoblastic LeukemiaPhase 2GRAALL-2014/TNCT02619630
Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old)
A Phase 2 study testing nelarabine in people with T-cell Adult Acute Lymphoblastic Leukemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate the efficacy of nelarabine-based consolidation and maintenance therapy in term of relapse-free survival (RFS) in high-risk (HR) patients. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- T-cell Adult Acute Lymphoblastic Leukemia
- What is being tested?
- nelarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Dec 2025
- Phase
- Phase 2
- 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
- Whose blood and bone marrow explorations have been completed before the steroids prephase
- aged 18-59 years old with a not previously treated (including IT injection) T-ALL newly-diagnosed according to the WHO 2008 definition with > 20% bone marrow blasts
- With Eastern Cooperative Oncology Group (ECOG) performance status < 3
- With or without central nervous system (CNS) involvement or testis
- Without other evolving cancer (except basal cell carcinoma of the skin and "in situ" carcinoma of the cervix) or its chemo or radio-therapy treatment finished at least since 6 months
- Having signed a written informed consent
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- With efficient contraception for women of childbearing age (excluding estrogens and IUD)
- Having received or being receiving steroid prephase
- With health insurance coverage
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 > 1.5 x 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 ejection ventricle fraction (LEVF) < 50% and/or RF < 30%,
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- Active severe infection or known seropositivity for HIV or Human T cell leukemia/lymphoma virus type 1 (HTLV-1) or active hepatitis B or C
- Other active malignancy
- Pregnant (beta-Human Chorionic Gonadotropin (hCG) positive) or nursing woman
- Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least three months thereafter. Patients not willing to ensure not to beget a child during participation in the study and at least three months thereafter
- Treated with any other investigational agent or participation in another trial within 30 days prior to entering this study
- 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
Hematology
Paris, 75010
Hervé Dombret, MDPhD, herve.dombret@aphp.fr
About this study
Official title: Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old): Evaluating the Efficacy of a Nelarabine Based Consolidation and Maintenance in High-risk Patients
The purpose of this study is to evaluate the efficacy of nelarabine-based consolidation and maintenance therapy in term of relapse-free survival (RFS) in high-risk (HR) patients.
- Being tested
- nelarabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nelarabineDrug
Nelarabine 1500 mg/m2/d (IV 2h) : D1, D3, D5 Cyclophosphamide 150 mg/m2/d (IV 3h) : D1, D3 etoposide (VP-16) 75 mg/m2/d (IV 1h) : D1, D3 granulocyte-colony stimulating factor 5 µg/kg/d (SC) : D7 until neutrophil >1 Giga/Liter
for a maximum of 5 blocks
| Study group | Role | What they receive |
|---|---|---|
| High-Risk (HR) patients | Experimental | Nelarabine during consolidation and maintenance Receives: Drug: nelarabine |
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 (9)
Overall survival
Measured: 4 years
Cumulative incidence of relapse
Measured: 4 years
Non relapse mortality (NRM)
Measured: 4 years
Disease free survival censored at allograft in first complete remission (CR)
Measured: 4 years
Cumulative incidence of relapse censored at allograft in first complete remission (CR)
Measured: 4 years
Overall survival censored at allograft in first complete remission (CR)
Measured: 4 years
Non relapse mortality (NRM) censored at allograft in first complete remission (CR)
Measured: 4 years
Minimal residual disease (MRD)
Measured: within 1 year
Proportion of patients having received the 5 cycles of nelarabine
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startDec 2015
- 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 (1)Papers the sponsor has linked to this study.
- Other trials for T-cell Adult 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619630
- Sponsor's protocol ID
- AOM12629_2
- Acronym
- GRAALL-2014/T
- Status last verified
- Feb 2019
- First submitted
- 25 Nov 2015
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boissel 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 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old): Evaluating the Efficacy of a Nelarabine Based Consolidation and Maintenance in High-risk Patients
- ClinicalTrials.gov ID
- NCT02619630
- Acronym / sponsor ID
- GRAALL-2014/T / AOM12629_2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Dec 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 evaluate the efficacy of nelarabine-based consolidation and maintenance therapy in term of relapse-free survival (RFS) in high-risk (HR) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-Risk (HR) patients | Experimental | Drug: nelarabineNelarabine during consolidation and maintenance |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Whose blood and bone marrow explorations have been completed before the steroids prephase
- aged 18-59 years old with a not previously treated (including IT injection) T-ALL newly-diagnosed according to the WHO 2008 definition with > 20% bone marrow blasts
- With Eastern Cooperative Oncology Group (ECOG) performance status < 3
- With or without central nervous system (CNS) involvement or testis
- Without other evolving cancer (except basal cell carcinoma of the skin and "in situ" carcinoma of the cervix) or its chemo or radio-therapy treatment finished at least since 6 months
Key exclusion criteria (13 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 ejection ventricle fraction (LEVF) < 50% and/or RF < 30%,
- Active severe infection or known seropositivity for HIV or Human T cell leukemia/lymphoma virus type 1 (HTLV-1) or active hepatitis B or C
- Other active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nelarabineNelarabine 1500 mg/m2/d (IV 2h) : D1, D3, D5 Cyclophosphamide 150 mg/m2/d (IV 3h) : D1, D3 etoposide (VP-16) 75 mg/m2/d (IV 1h) : D1, D3 granulocyte-colony stimulating factor 5 µg/kg/d (SC) : D7 until neutrophil >1 Giga/Liter for a maximum of 5 blocks | Drug | High-Risk (HR) patients |
Primary outcome
Disease free survival (DFS)
Time frame: 4 years
9 secondary outcomes
Overall survival
Time frame: 4 years
Cumulative incidence of relapse
Time frame: 4 years
Non relapse mortality (NRM)
Time frame: 4 years
Disease free survival censored at allograft in first complete remission (CR)
Time frame: 4 years
Cumulative incidence of relapse censored at allograft in first complete remission (CR)
Time frame: 4 years
Overall survival censored at allograft in first complete remission (CR)
Time frame: 4 years
Non relapse mortality (NRM) censored at allograft in first complete remission (CR)
Time frame: 4 years
Minimal residual disease (MRD)
Time frame: within 1 year
Proportion of patients having received the 5 cycles of nelarabine
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nelarabine in people with T-cell Adult 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 9 inclusion and 13 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 21 Oct 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.
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?
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 NCT02619630, which also lists 1 linked publication.
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 21 Oct 2019.