Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Phase 1

Terminated

• Conditions: Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Acute Lymphoblastic Leukemia
• Interventions: Drug: Nilotinib

• Registration Number: NCT00905398
• Lead Sponsor: Rony Schaffel

Brief Summary

Patients with acute lymphoblastic leukemia and positivity for the breakpoint cluster region-Abelson murine leukemia (BCR-ABL) protein or the Philadelphia chromosome have a poor prognosis with standard chemotherapy. The prognosis seemed to improve following the adition of imatinibe, a BCR-ABL inhibitor, to the treatment but still a substantial amount of patients relapse or progress during treatment.

Nilotinib is a BCR-ABL inhibitor more potent than imatinib. It has been shown to be effective against most of the cells that bear mutations of the BCR-ABL protein leading to resistance to imatinibe.

The investigators' hypothesis is that the addition of nilotinib to a standard chemotherapy for acute lymphoblastic leukemia (ALL) will translate into more rapid BCR-ABL reduction and effectiveness against imatinib-resistant clones leading to less relapses and better survival.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-20
• Primary Completion: 2012-06
• Status Verified: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-07
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Diagnosis of Acute Lymphoblastic Leukemia (ALL)
• BCR-ABL positive positive by PCR (central Lab)
• No previous treatment for ALL except for corticoids and cyclophosphamide less than 600 mg/m2
• Must be able to swallow tablets
• Lab results within normal limits (Potassium, Calcium, Magnesio, Phosphorus, Transaminases, Alkaline Phosphatase, Bilirrubine, Amylase, Lypase)

Exclusion Criteria

• Heart disease
• Interval QTc Fridericia > 480 msec
• Coumadin use
• Pregnancy
• PS = 4
• Previous medical history of etilism or/and pancreatic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nilotinib	Nilotinib	single arm study

Primary Outcome Measures

Name	Time	Method
Complete remission	Day + 21 and Day + 41

Secondary Outcome Measures

Name	Time	Method
Toxicity	Three times a week for the first 40 days than once weekly for the next 9 months than monthly for the next 2.1 years
Molecular remission	Every three months until three years
Overall Survival	Three years