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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Precursor B-Cell Lymphoblastic Leukemia-Lymphoma Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nilotinib

single arm study

Group Type EXPERIMENTAL

Nilotinib

Intervention Type DRUG

400mg, Oral, Bid, Daily for three years

Interventions

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Nilotinib

400mg, Oral, Bid, Daily for three years

Intervention Type DRUG

Other Intervention Names

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Tasigna AMN107

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No