Phase 2 N=91 Treatment

Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT00844298 ↗

Enrolled (actual)

Serious AEs

19.8%

Results posted

Sep 2015

Primary outcome: Primary: Proportion of Patients Achieving Hematologic and Molecular Complete Remission (CR) After Induction Therapy — 91 percentage of analyzable subjects

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Nilotinib+mVPD (Drug)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: Asan Medical Center
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Patients Achieving Hematologic and Molecular Complete Remission (CR) After Induction Therapy	91	—
SECONDARY Disease(Relapse)-Free Survival	—	—
SECONDARY Overall Survival	—	—

Summary

RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving nilotinib together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving nilotinib together with combination chemotherapy works in treating patients with newly diagnosed acute lymphoblastic leukemia.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Newly diagnosed acute lymphoblastic leukemia or acute mixed lineage leukemia
Positive for Bcr-Abl fusion transcript (Philadelphia chromosome-positive disease) by RT-PCR

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Total bilirubin 450 msec on baseline ECG (using the QTcF formula)
Myocardial infarction within the past 12 months
Other clinically significant heart disease, including any of the following:
Unstable angina
Congestive heart failure
Uncontrolled hypertension
Uncontrolled arrhythmias
No other primary malignant disease requiring systemic treatment
No acute or chronic liver, pancreatic, or severe renal disease
No other severe and/or life-threatening medical disease
No history of significant congenital or acquired bleeding disorder unrelated to cancer
No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug
No history of non-compliance

PRIOR CONCURRENT THERAPY:

More than 30 days since prior investigational agents
No concurrent medications that have the potential to prolong the QTc interval
No concurrent strong CYP3A4 inhibitors
No concurrent therapeutic coumarin derivatives

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00844298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.