Cholecalciferol in Treating Patients With Acute Myeloid Leukemia Undergoing Intensive Induction Chemotherapy
|ClinicalTrials.gov Identifier: NCT01521936|
Recruitment Status : Terminated (Lack of funding)
First Posted : January 31, 2012
Last Update Posted : June 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monocytic Leukemia (M5b) Adult Acute Myeloblastic Leukemia With Maturation (M2) Adult Acute Myeloblastic Leukemia Without Maturation (M1) Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Acute Myelomonocytic Leukemia (M4) Adult Erythroleukemia (M6a) Adult Pure Erythroid Leukemia (M6b) Untreated Adult Acute Myeloid Leukemia||Dietary Supplement: cholecalciferol Other: pharmacological study Other: laboratory biomarker analysis||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Vitamin D3 Supplementation in Acute Myeloid Leukemia: Pharmacokinetic Study|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||June 2015|
Experimental: Arm I (25(OH)-D3 levels 20-31.9 ng/mL [insufficient levels])
Patients receive a loading dose of cholecalciferol PO on day 1. Patients then receive lower-dose cholecalciferol PO beginning on day 8.
Dietary Supplement: cholecalciferol
Given PO (lower dose)
Other Names:Other: pharmacological study
Other Name: pharmacological studiesOther: laboratory biomarker analysis
Experimental: Arm II (25(OH)-D3 levels 20-31.9 ng/mL [insufficient levels])
Patients receive a loading dose of cholecalciferol PO on day 1. Patients then receive higher-dose cholecalciferol PO beginning on day 8.
Other: pharmacological study
Other Name: pharmacological studiesDietary Supplement: cholecalciferol
Given PO (higher dose)
Other Names:Other: laboratory biomarker analysis
- Changes in 25(OH)-D3 levels after supplementation [ Time Frame: From baseline to monthly for the first 3 months and then every 3 months ]The within-group pre- and post-supplementation levels will be summarized separately and the within-subject change will also be computed. To assess within-arm treatment effects the sign test will be used.
- Pharmacokinetic parameters [ Time Frame: 30 minutes before administration, 30 minutes after administration, and 24 hours after administration on day 1; monthly for the first 3 months; and then every 3 months ]Summarized using the mean (with corresponding 90% confidence intervals) and standard deviation.
- Safety and toxicity parameters [ Time Frame: Daily for 21 days and monthly thereafter, up to 30 days after last dose of study drug ]Rates corresponding to toxicity endpoints will be estimated using simple relative frequencies. The corresponding 90% confidence intervals for the estimated probabilities will be computed using the method proposed in Clopper and Pearson. Comparison between groups will be done in an exploratory fashion using appropriate two-sample tests. A nominal significance level of 0.10 will be used in all testing.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521936
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Meir Wetzler||Roswell Park Cancer Institute|