Study to Evaluate Nilotinib in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ Acute Lymphoblastic Leukemia (ALL) (Extension Study)

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Myelogenous Leukemia; Acute Lymphoblastic Leukemia

Treatments: Drug: Nilotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01279473

TAS-3-01

CAMN107A1101E1

Details and patient eligibility

About

This study will investigate if nilotinib provides an improved safety and efficacy profile over that seen in patients receiving Imatinib.

Enrollment: 42 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who complete CAMN107A1101 and obtained Informed concent by document

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Nilotinib

Experimental group

Treatment:

Drug: Nilotinib