Phase I, Dose Escalation Study of Decitabine
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|ClinicalTrials.gov Identifier: NCT02264873|
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : October 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Lymphoblastic, Acute Leukemia, Myeloid Acute Hematopoetic Myelodysplasia||Drug: Decitabine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Minimizing Leukemia Relapse: A Phase I, Dose Escalation Study of Decitabine in High Risk Pediatric Leukemia Post Allogeneic Transplant|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||September 18, 2018|
This is a 3+3 design of dose escalation
Dose escalation starting at 5 mg, and increasing by 2.5 mg to a Dose Level of 12.5 mg qd x 3 days.
Other Name: Decitabine, Dacogen
- Maximum Tolerated Dose as a Measure of Safety and Tolerability [ Time Frame: 3 months ]This is a dose escalation study of decitabine maintenance therapy after allo-HSCT for the maximally tolerated dose in pediatric patients without adverse events.
- Adverse Event Profile After Single Cycle Decitabine Post Transplant [ Time Frame: 6 months ]The adverse events will be graded using the NCI Scale after one cycle of decitabine maintenance therapy intravenously. Grade 1 and 2 are unexpected and expect but unlikely related or unrelated; Grade 3 unexpected with hospitalization within 10 calendar days or possibly, probable related and without hospitalization; Grade 3 expected with hospitalization within 10 days or without hospitalization; Grade 4 and 5 Unexpected and Expected 24-hours to 5 days unlikely, unrelated, possible, probable, definite.
- Grade 3 Adverse Events after Decitabine [ Time Frame: 6 months ]To estimate the incidences of ≥ grade 3 adverse events, infections, need for transfusions, treatment related mortality (TRM), and incidence and severity of graft vs host disease (GVHD) after initiation of decitabine post-HSCT. The grading will be done with the NCI Scale Grade 3 unexpected with hospitalization within 10 calendar days or possibly, probable related and without hospitalization; Grade 3 expected with hospitalization within 10 days or without hospitalization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264873
|United States, Florida|
|UF Health Shands Hospital|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Paul Castillo, MD||University of Florida|