NCT01521936

Brief Summary

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

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 19, 2015

Status Verified

June 1, 2015

Enrollment Period

1.2 years

First QC Date

January 26, 2012

Last Update Submit

June 18, 2015

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) AbnormalitiesAdult 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

Outcome Measures

Primary Outcomes (3)

  • Changes in 25(OH)-D3 levels after supplementation

    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

    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

    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

Study Arms (2)

Arm I (25(OH)-D3 levels 20-31.9 ng/mL [insufficient levels])

EXPERIMENTAL

Patients receive a loading dose of cholecalciferol PO on day 1. Patients then receive lower-dose cholecalciferol PO beginning on day 8.

Dietary Supplement: cholecalciferolOther: pharmacological studyOther: laboratory biomarker analysis

Arm II (25(OH)-D3 levels 20-31.9 ng/mL [insufficient levels])

EXPERIMENTAL

Patients receive a loading dose of cholecalciferol PO on day 1. Patients then receive higher-dose cholecalciferol PO beginning on day 8.

Other: pharmacological studyDietary Supplement: cholecalciferolOther: laboratory biomarker analysis

Interventions

cholecalciferolDIETARY_SUPPLEMENT

Given PO (lower dose)

Also known as: Calciol, Vitamin D3
Arm I (25(OH)-D3 levels 20-31.9 ng/mL [insufficient levels])
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Arm I (25(OH)-D3 levels 20-31.9 ng/mL [insufficient levels])Arm II (25(OH)-D3 levels 20-31.9 ng/mL [insufficient levels])
laboratory biomarker analysisOTHER

Correlative studies

Arm I (25(OH)-D3 levels 20-31.9 ng/mL [insufficient levels])Arm II (25(OH)-D3 levels 20-31.9 ng/mL [insufficient levels])

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Leukemia, Megakaryoblastic, AcuteLeukemia, Monocytic, AcuteLeukemia, Myeloid, AcuteCongenital AbnormalitiesLeukemia, Myelomonocytic, AcuteLeukemia, Erythroblastic, Acute

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMyeloproliferative DisordersBone Marrow Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Meir Wetzler

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2012

First Posted

January 31, 2012

Study Start

December 1, 2011

Primary Completion

March 1, 2013

Study Completion

June 1, 2015

Last Updated

June 19, 2015

Record last verified: 2015-06

Locations

US(1)