AzTrials
AzTrials

Adult Acute Megakaryoblastic Leukemia (M7)Phase 2NCT01521936

Cholecalciferol in Treating Patients With Acute Myeloid Leukemia Undergoing Intensive Induction Chemotherapy

A Phase 2 study testing cholecalciferol, pharmacological study and laboratory biomarker analysis in people with Adult Acute Megakaryoblastic Leukemia (M7) and Adult Acute Monoblastic Leukemia (M5a), run by Roswell Park Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cholecalciferol, pharmacological study and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
Dec 2011to Jun 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: 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

Read the 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.

Being tested
cholecalciferol, pharmacological study, laboratory biomarker analysis
Medical subject headings
Leukemia, Megakaryoblastic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myeloid, Acute, Congenital Abnormalities, Leukemia, Myelomonocytic, Acute, Leukemia, Erythroblastic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cholecalciferolDietary supplement

    Also called Calciol, Vitamin D3

    Given PO (lower dose)

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • cholecalciferolDietary supplement

    Also called Calciol, Vitamin D3

    Given PO (higher dose)

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01521936
Study groupRoleWhat they receive
Arm I (25(OH)-D3 levels 20-31.9 ng/mL [insufficient levels])ExperimentalPatients receive a loading dose of cholecalciferol PO on day 1. Patients then receive lower-dose cholecalciferol PO beginning on day 8.
Receives: Dietary Supplement: cholecalciferol; Other: pharmacological study; Other: laboratory biomarker analysis
Arm II (25(OH)-D3 levels 20-31.9 ng/mL [insufficient levels])ExperimentalPatients receive a loading dose of cholecalciferol PO on day 1. Patients then receive higher-dose cholecalciferol PO beginning on day 8.
Receives: Other: pharmacological study; Dietary Supplement: cholecalciferol; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From baseline to monthly for the first 3 months and then every 3 months

  2. Pharmacokinetic parameters

    Summarized using the mean (with corresponding 90% confidence intervals) and standard deviation.

    Measured: 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

  3. 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.

    Measured: Daily for 21 days and monthly thereafter, up to 30 days after last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2012 (estimated)
  2. Study startDec 2011
  3. Primary completionMar 2013
  4. Study completionJun 2015

Why it stopped: Lack of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01521936
Sponsor's protocol ID
I 201311
Other IDs
NCI-2011-03554
Status last verified
Jun 2015
First submitted
26 Jan 2012
Last updated
19 Jun 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cholecalciferol, pharmacological study and laboratory biomarker analysis in people with Adult Acute Megakaryoblastic Leukemia (M7) and Adult Acute Monoblastic Leukemia (M5a), run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01521936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in