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Vitamin D3 Supplementation in Acute Myeloid Leukemia: Pharmacokinetic Study


Phase 2
18 Years
N/A
Open (Enrolling)
Both
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

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Trial Information

Vitamin D3 Supplementation in Acute Myeloid Leukemia: Pharmacokinetic Study


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Changes in 25(OH)-D3 levels after supplementation

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Meir Wetzler

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 201311

NCT ID:

NCT01521936

Start Date:

December 2011

Completion Date:

Related Keywords:

  • 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
  • Congenital Abnormalities
  • Leukemia
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Megakaryoblastic, Acute
  • Leukemia, Monocytic, Acute
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Myelomonocytic, Chronic

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263