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Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old) (GRAALL-2014/T)

Primary Purpose

T-cell Adult Acute Lymphoblastic Leukemia

Status

Recruiting

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

nelarabine

About this trial

This is an interventional treatment trial for T-cell Adult Acute Lymphoblastic Leukemia

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
With efficient contraception for women of childbearing age (excluding estrogens and IUD)
Having received or being receiving steroid prephase
With health insurance coverage

Exclusion Criteria:

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%,
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

Sites / Locations

HematologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High-Risk (HR) patients

Arm Description

Nelarabine during consolidation and maintenance

Outcomes

Primary Outcome Measures

Disease free survival (DFS)

Secondary Outcome Measures

Overall survival

Cumulative incidence of relapse

Non relapse mortality (NRM)

Disease free survival censored at allograft in first complete remission (CR)

Cumulative incidence of relapse censored at allograft in first complete remission (CR)

Overall survival censored at allograft in first complete remission (CR)

Non relapse mortality (NRM) censored at allograft in first complete remission (CR)

Minimal residual disease (MRD)

Proportion of patients having received the 5 cycles of nelarabine

Full Information

NCT ID

NCT02619630

First Posted

November 25, 2015

Last Updated

October 18, 2019

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT02619630

Brief Title

Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old)

Acronym

GRAALL-2014/T

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Recruiting

Study Start Date

December 2015 (undefined)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

T-cell Adult Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

275 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High-Risk (HR) patients

Arm Type

Experimental

Arm Description

Nelarabine during consolidation and maintenance

Intervention Type

Drug

Intervention Name(s)

nelarabine

Intervention Description

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

Primary Outcome Measure Information:

Title

Disease free survival (DFS)

Time Frame

4 years

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

4 years

Title

Cumulative incidence of relapse

Time Frame

4 years

Title

Non relapse mortality (NRM)

Time Frame

4 years

Title

Disease free survival censored at allograft in first complete remission (CR)

Time Frame

4 years

Title

Cumulative incidence of relapse censored at allograft in first complete remission (CR)

Time Frame

4 years

Title

Overall survival censored at allograft in first complete remission (CR)

Time Frame

4 years

Title

Non relapse mortality (NRM) censored at allograft in first complete remission (CR)

Time Frame

4 years

Title

Minimal residual disease (MRD)

Time Frame

within 1 year

Title

Proportion of patients having received the 5 cycles of nelarabine

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 With efficient contraception for women of childbearing age (excluding estrogens and IUD) Having received or being receiving steroid prephase With health insurance coverage Exclusion Criteria: 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%, 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hervé Dombret, MDPhD

Phone

+33 (0)1 57 27 68 47

herve.dombret@aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Véronique Lhéritier

Phone

+33(0)4 78 86 22 39

veronique.lheritier@chu-lyon.fr

Facility Information:

Facility Name

Hematology

City

Paris

ZIP/Postal Code

75010

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hervé Dombret, MDPhD

herve.dombret@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old)

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