NCT00030069

Brief Summary

This is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2002

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

6 years

First QC Date

January 30, 2002

Last Update Submit

January 14, 2016

Conditions

Myelodysplastic Syndromes

Keywords

HematopoiesisApoptosisCell DifferentiationBone Marrow Cells

Interventions

CalcitriolDRUG
DexamethasoneDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed refractory anemia (RA), RA with excess blasts (RAEB), RAEB in transformation (RAEB-IT), or ringed sideroblasts (RARS)
  • Evidence of cytopenia affecting at least 1 hematological cell lineage
  • Adequate liver and renal function
  • ECOG 0-2
  • Expected survival of at least 12 weeks

You may not qualify if:

  • Symptomatic coronary artery disease
  • Uncontrolled diabetes mellitus
  • Uncontrolled and symptomatic glaucoma
  • History of dangerous reactions to steroid therapy
  • Chemotherapy or any hematopoietic growth factor therapy within the past 8 weeks
  • History of nephrolithiasis
  • Children
  • Chronic myelomonocytic leukemia (CMML)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

CalcitriolDexamethasone

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsPregnadienetriolsPregnadienesPregnanesSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2002

First Posted

January 31, 2002

Study Start

September 1, 2001

Primary Completion

September 1, 2007

Study Completion

May 1, 2009

Last Updated

January 15, 2016

Record last verified: 2016-01

Locations

US(1)