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

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02619630
• Collaborator: (none)
• Enrollment: 275
• Location: 1
• Arm: 1
• Duration (Months): 120
• Patients Per Site Per Month: 2.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
T-cell Adult Acute Lymphoblastic Leukemia	Drug: nelarabine	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 275 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Dec 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-Risk (HR) patients Nelarabine during consolidation and maintenance	Drug: nelarabine; 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

Outcome Measures

Primary Outcome Measures

1. Disease free survival (DFS) [4 years]

Secondary Outcome Measures

1. Overall survival [4 years]

2. Cumulative incidence of relapse [4 years]

3. Non relapse mortality (NRM) [4 years]

4. Disease free survival censored at allograft in first complete remission (CR) [4 years]

5. Cumulative incidence of relapse censored at allograft in first complete remission (CR) [4 years]

6. Overall survival censored at allograft in first complete remission (CR) [4 years]

7. Non relapse mortality (NRM) censored at allograft in first complete remission (CR) [4 years]

8. Minimal residual disease (MRD) [within 1 year]

9. Proportion of patients having received the 5 cycles of nelarabine [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 59 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Whose blood and bone marrow explorations have been completed before the steroids prephase

2. 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

3. With Eastern Cooperative Oncology Group (ECOG) performance status < 3

4. With or without central nervous system (CNS) involvement or testis

5. 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

6. Having signed a written informed consent

7. With efficient contraception for women of childbearing age (excluding estrogens and IUD)

8. Having received or being receiving steroid prephase

9. With health insurance coverage

Exclusion Criteria:

1. With lymphoblastic lymphoma and bone marrow blasts < 20%, Burkitt-type ALL or with antecedents of chronic myeloid leukemia (CML) or other myeloproliferative neoplasm

2. 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

1. 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%,

2. 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

3. Other active malignancy

4. Pregnant (beta-Human Chorionic Gonadotropin (hCG) positive) or nursing woman

5. 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

6. Treated with any other investigational agent or participation in another trial within 30 days prior to entering this study

7. Not able to bear with the procedures or the frequency of visits planned in the trial

8. Unable to consent, under tutelage or curators, or judiciary safeguard

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hematology	Paris		France	75010

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT02619630
• Other Study ID Numbers: AOM12629_2
• First Posted: Dec 2, 2015
• Last Update Posted: Oct 21, 2019
• Last Verified: Feb 1, 2019

• Additional relevant MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Results

No Results Posted as of Oct 21, 2019