A Multicenter Phase I/II Study of the Prophylactic Inhibition of BCR-ABL Tyrosine Kinase by Tasigna (Nilotinib) After Hematopoietic Cell Transplantation for Philadelphia Chromosome-Positive Leukemias.

This phase I/II trial is studying the side effects and best way to give nilotinib when given together with 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.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : imatinib mesylate
  • drug : nilotinib
  • other : pharmacological study

Phase: Phase 1/Phase 2

Eligibility

Ages Eligible For Study:

N/A - N/A

Inclusion Criteria

- 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

External Links

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Contact information

Primary Contact:

Physician Referrals 6507230822

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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