Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML

Completed · Phase 1/Phase 2

Conditions studied: Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Blastic Phase Chronic Myelogenous Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia, Philadelphia Positive Adult Acute Lymphoblastic Leukemia, Philadelphia Positive Childhood Acute Lymphoblastic Leukemia, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Relapsing Chronic Myelogenous Leukemia, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Childhood Acute Lymphoblastic Leukemia

In brief

This phase I/II trial is studying the side effects and best way to give nilotinib when given alone or sequentially after imatinib mesylate after donor stem cell transplant in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia. Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID: NCT00702403
Run by: Fred Hutchinson Cancer Center
People needed: 40
Starts: 2008-08-14
Expected to finish: 2013-12-01
Last updated by the study team: 2017-08-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Body surface area >= 1 m\^2
Allogeneic HCT
Acute lymphocytic leukemia (ALL) or chronic myelogenous leukemia (CML) characterized by the p190 and/or p210 BCR/ABL gene rearrangement
CML in accelerated phase, blast crisis, or blast crisis remission as defined by World Health Organization (WHO) criteria
CML in chronic phase if patient age =< 17 years or a patient of any age with CML in second chronic phase or beyond
Patients with minimal residual disease (MRD) that is not declining in response to tyrosine kinase inhibitor therapy must be screened for the T315I and other mutations
An appropriately matched related or unrelated donor
Signed informed consent
Patient must have a life expectancy of at least 2 months
Stated willingness of the patient to comply with study procedures and reporting requirements
Creatinine =< 2.0 x upper limit normal (ULN)
Platelets > 20 x 10\^9 /L
Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x ULN, conjugated bilirubin < 3 x ULN
Serum potassium phosphorus, magnesium, and calcium >= lower limit normal (LLN) or correctable with supplements prior to first dose of study drug; calcium levels may be corrected for hypoalbuminemia
Serum amylase and lipase < 1.5 x ULN
Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing; postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
Careful rationalization with a view to discontinuing or considering alternatives to any concomitant medications that have potential to prolong the QT interval

You may not qualify if…

Autologous transplant
Non-myeloablative transplant
Patient age > 17 years with CML in first chronic phase
Aberrant antigen expression on marrow leukemic blasts >= 5% by multidimensional flow cytometric assay immediately before conditioning (CML patients in chronic phase exempt from flow cytometry screening)
Ph+ ALL without complete cytogenetic remission immediately before conditioning
Known T315I mutation
Hypersensitivity to Gleevec or Tasigna
Patients who are Tasigna-resistant or intolerant
Central nervous system (CNS) involvement with leukemia at baseline (pre-imatinib therapy); CML chronic phase (CP), accelerated phase (AP) patients exempt from CNS involvement screening
Female patients who are pregnant, breast-feeding, or of childbearing potential without a negative serum pregnancy test at screening; male or female patients of childbearing potential unwilling to use effective contraceptive precautions throughout the trial; post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
Life expectancy severely limited by diseases other than leukemia
Myocardial infarction within one year prior to starting nilotinib
Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, unstable angina)
Absolute neutrophil count (ANC) less than 1500 per microliter at study entry despite the use of filgrastim (G-CSF)
Impaired cardiac function, including any one of the following:
Complete left bundle branch block or bifascicular block (right bundle branch block plus left anterior hemiblock) or use of ventricular-paced pacemaker
Congenital long QT syndrome or a family history of long QT syndrome
History of or presence of significant ventricular or atrial tachyarrhythmias
Clinically significant resting bradycardia (< 50 beats per minute)
Corrected QT interval (QTc) > 450 milliseconds on screening electrocardiogram (ECG); if QTc > 450 and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient rescreened for QTc

Where it is running

Stanford University Hospitals and Clinics — Stanford, California, United States
H Lee Moffitt Cancer Center and Research Institute Phase 2 Consortium — Tampa, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
Oregon Health and Science University — Portland, Oregon, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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