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Bone Marrow Transplant

Nilotinib and Imatinib Mesylate Post SCT for Patients With ALL or CML (FHCRC-2223)
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
Status Conditions Phase Study ID
Closed Acute Lymphoid Leukemia (ALL); Chronic Myeloid Leukemia (CML); Hematologic Malignancies; Leukemia Phase I/II FHCRC-2223
NCT00702403
Summary

RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: 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.


Investigator
Paul Carpenter, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

 

 

  • Body surface area >= 1 m^2
  • Allogeneic HCT
  • ALL or 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 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 MRD 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
  • Stated willingness of the long-term follow-up "managing physician" (usually referring physician) to comply with study procedures and reporting requirements
  • Creatinine < 1.5 x ULN
  • Platelets > 20 x 10^9 /L
  • Serum potassium phosphorus, magnesium, and calcium >= LLN or correctable with supplements prior to first dose of study drug
  • Serum amylase and lipase < 1.5 x ULN
  • AST/ALT =< 3 x ULN
  • Conjugated bilirubin < 3 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

 

Exclusions (conditions that would prevent participation in this study)
  • 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
  • ANC less than 1500 per microliter at study entry despite the use of 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; LVEF < 45% as determined by MUGA scan or echocardiogram IRB Approved; 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)
  • QTcF > 450 milliseconds on screening ECG (using the QTcF formula); if QTc > 450 and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient rescreened for QTc
  • Myocardial infarction within one year prior to starting nilotinib
  • Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, unstable angina)
  • CNS involvement with leukemia at baseline (pre-imatinib therapy); CML CP, AP patients exempt from CNS involvement screening
  • Hypersensitivity to Gleevec or Tasigna
  • Patients who are Tasigna-resistant or intolerant
  • 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
  • Postmenopausal 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

 

Last Updated
June 20, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.