- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01521936
Cholecalciferol in Treating Patients With Acute Myeloid Leukemia Undergoing Intensive Induction Chemotherapy
June 18, 2015 updated by: Roswell Park Cancer Institute
Vitamin D3 Supplementation in Acute Myeloid Leukemia: Pharmacokinetic Study
This partially randomized phase II trial studies the side effects and best way to give and best dose of cholecalciferol in treating patients with acute myeloid leukemia (AML) undergoing intensive induction chemotherapy.
Cholecalciferol may help improve the outcome of patients with AML undergoing intensive chemotherapy
Study Overview
Status
Terminated
Conditions
- 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
Detailed Description
PRIMARY OBJECTIVES: I. To assess patients with regards to changes in 25(OH)-D3 changes after supplementation.
II.
To develop a pharmacokinetic model to describe the time course of the relationship of vitamin D3 (cholecalciferol) supplementation that drives the levels of 25(OH)-D3 during the intensive induction chemotherapy.
III.
To determine the safety and toxicity of vitamin D3 supplementation in AML patients undergoing intensive induction chemotherapy.
SECONDARY OBJECTIVES: I. To explore whether rapid (loading dose of vitamin D3) normalization of 25(OH)-D3 levels will have an effect on the progression free and overall survival.
II.
To explore whether a relationship exists between the pharmacokinetics of the 25-hydroxy-vitamin D3 and white blood cell count.
OUTLINE: Patients with pretreatment 25(OH)-D3 levels 20-31.9
ng/mL (insufficient levels) are randomized to 1 of 2 treatment arms.
ARM I: Patients receive a loading dose of cholecalciferol orally (PO) on day 1.
Patients then receive lower-dose cholecalciferol PO beginning on day 8. ARM II: Patients receive a loading dose of cholecalciferol PO on day 1.
Patients then receive higher-dose cholecalciferol PO beginning on day 8. Patients with pretreatment 25(OH)-D3 levels < 20 ng/mL (deficient levels) receive a loading dose of cholecalciferol PO on days 1 and 8. Patients then receive lower-dose cholecalciferol PO beginning on day 15.
For all patients, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria: Pathologic diagnosis of newly diagnosed AML (excluding acute promyelocytic leukemia [APL]) Patients undergoing intensive induction therapy (equivalent of 7+3, cytarabine, daunorubicin, etoposide [ADE] or high-dose cytarabine containing regimens) Subnormal 25(OH)-D3 levels (< 32 ng/mL) Serum calcium =< upper limit of normal Demonstrate the ability to swallow and retain oral medication Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: Patients should not have a history of nephrocalcinosis Patients should not have received bisphosphonate treatment within 28 days before study entry Pregnant or nursing female patients Unwilling or unable to follow protocol requirements Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug Received an investigational agent within 30 days prior to enrollment Patients who cannot be discontinued from cimetidine, thiazide diuretics and/or heparin Patients who are on magnesium based antacids who cannot be offered an alternative regimen
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Correlative studies
Correlative studies
Other Names:
Given PO (lower dose)
Other Names:
Given PO (higher dose)
Other Names:
|
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.
|
Correlative studies
Correlative studies
Other Names:
Given PO (lower dose)
Other Names:
Given PO (higher dose)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From baseline to monthly for the first 3 months and then every 3 months
|
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.
|
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
|
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.
|
Daily for 21 days and monthly thereafter, up to 30 days after last dose of study drug
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Meir Wetzler, Roswell Park Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
January 26, 2012
First Submitted That Met QC Criteria
January 26, 2012
First Posted (Estimate)
January 31, 2012
Study Record Updates
Last Update Posted (Estimate)
June 19, 2015
Last Update Submitted That Met QC Criteria
June 18, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Leukemia, Myelomonocytic, Acute
- Leukemia, Monocytic, Acute
- Leukemia, Megakaryoblastic, Acute
- Leukemia, Erythroblastic, Acute
- Physiological Effects of Drugs
- Micronutrients
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Vitamins
- Ergocalciferols
Other Study ID Numbers
- I 201311
- NCI-2011-03554 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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