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Report for Clinical Trial NCT01528085

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Open Label Phase II Study to Evaluate the Efficacy and Safety of Induction and Consolidation Therapy With Nilotinib in Combination With Chemotherapy in Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL)

The goal of this trial is to evaluate the efficacy and the tolerance of the combination of nilotinib with chemotherapy in the front-line setting as induction and consolidation therapy in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be used in this trial with the addition of nilotinib as concomitant therapy during induction, consolidation and maintenance. The patients will be prospectively monitored for minimal residual disease and bcr-abl tyrosine kinase domain mutations.

NCT01528085 Philadelphia Chromsome Positive Acute Lymphoblastic Leukemia
MeSH:Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Philadelphia Chromosome
HPO:Leukemia Lymphoid leukemia

1 Interventions

Name: Nilotinib

Description: Nilotinib, p.o Chemotherapy (Dexamethasone, Methotroxate, Cyclophosphamide (optional), Vincristine, Vindesine, Cytarabine, 6-Mercapto-Purine)
Type: Drug


Primary Outcomes

Description: rate of patients without event

Measure: Evaluation of efficacy of a nilotinib-based induction and consolidation therapy

Time: after 12 months

Secondary Outcomes

Description: The rate of complete haematological remission after induction treatment

Measure: complete haematological remission

Time: after induction treatment (week 5)

Description: major molecular response defined by a BCR-ABL/ABL < 0.1% in bone marrow

Measure: major molecular response in bone marrow

Description: complete molecular response defined by a BCR-ABL/ABL < 0.001% in bone marrow

Measure: complete molecular response

Description: The proportion of patients with confirmed undetectable BCR-ABL level with a test sensitivity of at least 4.5 log.

Measure: undetectable BCR-ABL level

Measure: Event free survival

Measure: Relapse free survival

Measure: Progression free survival

Description: Detection of a T315I or p-loop BCR-ABL TK domain mutation

Measure: T315I or p-loop Mutations

Description: The proportion of patients with molecular relapse or progression

Measure: molecular relapse or progression

Measure: Overall survival

Description: Tolerability as determined by descriptive assessment of adverse events and discontinuation due to treatment-related SAEs

Measure: Tolerability

Description: (all patients who started treatment)

Measure: Death during induction

Time: End of induction (week 5)

Measure: Death in complete remission

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T315I

T315I or p-loop Mutations. --- T315I ---

Detection of a T315I or p-loop BCR-ABL TK domain mutation. --- T315I ---



HPO Nodes


HPO: