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)

A Phase I/II Multicenter, Dose-escalation Study of Oral Nilotinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ALL (Philadelphia Positive Acute Lymphocytic Leukemia)(Extension Study)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01279473

Enrollment

Registered

2011-01-19

Start date

2005-08-31

Completion date

Unknown

Last updated

2020-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia

Keywords

Chronic Myelogenous Leukemia, CML, Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive, ph+ ALL, Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)

Brief summary

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

Interventions

DRUGNilotinib

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients who complete CAMN107A1101 and obtained Informed concent by document

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Number of Adverse Events	3 weeks

Secondary

Measure	Time frame
Best hematologic response rate and Best cytogenetic response rate.	3 years
Percentage of BCR-ABL genes transcript and mutation status of BCR-ABL	3 years

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026