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This study evaluates the drug Azacitidine (AZA) in patients with Chronic Myeloid Leukemia (CML) who still have minimal residual disease despite tyrosine kinase inhibitor therapy. It included Philadelphia/BCR-ABL-positive patients over 16 who had received TKI therapy for at least 18 months. It was a Phase 1 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Patients 16 years or older with Philadelphia chromosome (Ph)- or BCR/ABL-positive CML (as determined by cytogenetics, FISH, or PCR). 2. Patients must have received FDA-approved TKI therapy for at least 18 months and not have increased their dose of FDA-approved TKI in the last 6 months. Patients participating on frontline protocols 2005-0048 (nilotinib) and 2005-0422 (dasatinib) are eligible for enrollment on this study. 3. Phase II patients must be in complete cytogenetic remission. For the phase I portion of the study, patients may be included without a complete cytogenetic remission provided they are in chronic phase. 4. Phase II patients must have detectable BCR-ABL transcript levels meeting at least one of the following criteria: Patient has never achieved a major molecular response, and transcript levels have shown in at least two consecutive measures separated by at least 1 month to have increased by any value, or Achieved a major molecular response that has been lost with an increase in transcript levels by at least 1-log, confirmed in two consecutive analyses separated by at least 1 month, or The patient has received therapy for at least 2 years and does not have a sustained major molecular response, or The patient has received therapy for at least 5 years and does not have a sustained complete molecular response. Patients included in the phase I portion of the study are eligible regardless of their level of BCR-ABL transcripts. 5. Patients must not have had a known continuous interruption of imatinib therapy of greater than 14 days or for a total of 6 weeks in the 6 months prior to enrollment. 6. Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital. 7. ECOG performance status \</= 2. 8. Adequate organ function defined as: bilirubin \< 2x upper limit of normal (ULN) (unless associated with Gilbert's syndrome), and ALT or AST \</= 2.5x ULN. 9. ANC \>/=1 x10(9)/L and platelets \>/= 50 x10(9)/L. 10. Serum creatinine \< 1.8 mg/dL or creatinine clearance greater or equal than 40 cc/min as defined by the Cockcroft-Gault Equation\*. Males(mL/min):(140-age)\* ABW(kg) / 72\* (serum creatinine(mg/dl)); Females (mL/min):0.85\*(140-age)\* ABW(kg) / 72\*(serum creatinine (mg/dl)) 11. Women of childbearing potential should be advised to avoid becoming pregnant and practice effective methods of contraception. Men should be advised not to father a child while receiving treatment with azacitidine. Azacitidine is classified as Pregnancy Category D. Females of childbearing potential: Recommendation is for 2 effective contraceptive methods during the study. Adequate forms of contraception are double-barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices, and tubal ligation. Male patients with female partners who are of childbearing potential: Recommendation is for male and partner to use at least 2 effective contraceptive methods, as described above, during the study. 12. Women of childbearing potential should have a pregnancy test within 7 days before initiation of study drug. Exclusion Criteria: 1. Patients receiving any other investigational agents. 2. Patients who are pregnant or breast-feeding. 3. Patients with clinically significant heart disease (NYHA Class III or IV). 4. Known or suspected hypersensitivity to azacitidine or mannitol. 5. Patients with advanced malignant hepatic tumors.