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

Rony Schaffel

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Acute Lymphoblastic Leukemia

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Treatments

Drug: Nilotinib

Study type

Interventional

Funder types

Other

Identifiers

NCT00905398

BrALL 01-08

25351732040200851

ANVISA

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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