Safety and Efficacy of Iron Reduction by Phlebotomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andrea Kew, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00689182
First received: May 30, 2008
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

Hypothesis: The reduction of total body iron by phlebotomy will be safe and feasible in the post-HSCT setting 

Iron overload is common after hematopoietic stem cell transplantation. It is associated with chronic liver disease, with increased rates of infection and decreased survival.

Eligible, consenting patients will have once monthly phlebotomy procedures (500ml) for 12 months.

SAFETY: At each visit, patients will have a comprehensive assessment prior to starting and after completing the phlebotomy. This assessment will include determination of pain at phlebotomy site, local infection and an assessment of symptoms of anemia including presyncope, fatigue and dyspnea. The patient's pulse, blood pressure, respiratory rate and temperature will also be determined before and following the phlebotomy.

EFFICACY: Iron stores will be measured serially in each patient. Measurements will be performed prior to the start of phlebotomy, and at 6 months and 12 months following the start of the series of 12 phlebotomies. These evaluations will be undertaken regardless of the number of phlebotomies which the patient actually undergoes. Iron stores will be estimated by measuring serum ferritin and transferrin saturation levels. Total body iron will be estimated from hepatic and cardiac iron concentration as measured by magnetic resonance imaging (MRI). Gandon et al. (12) described a non-invasive technique using MRI to measure hepatic iron stores. Iron is a paramagnetic substance which causes local magnetic field inhomogeneities leading to dephasing and signal loss in MRI. Gradient echo sequences are most susceptible to their effects because they do not use a 180° refocusing pulse, unlike conventional spin-echo sequences. Gandon et al. used multiple gradient echo sequences, compared the signal in liver to adjacent muscle and used this ratio to correlate with hepatic iron levels measured on tissue biopsy samples using spectrophotometric analysis. Multiple sequences were used because the nomogram comparing the L/M signal ratio is linear over only a small concentration of tissue iron.


Condition Intervention Phase
Iron Overload
Procedure: monthly phlebotomy x 12 months
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of the Safety and Efficacy of Iron Reduction by Phlebotomy in Recipients of Hematopoietic Stem Cell Transplants

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Iron stores, total body iron [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: May 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
All patients will receive phlebotomy
Procedure: monthly phlebotomy x 12 months
All patients will receive monthly phlebotomies.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • consecutive patients who have undergone autologous or allogeneic HSCT
  • who are red-cell transfusion-independent
  • at least 60 days post-transplant
  • serum ferritin of at least 1000ug/L
  • ECOG less than or equal to 2.0

Exclusion Criteria:

  • pregnancy
  • breast-feeding
  • serious infection
  • HIV antibody positive
  • renal failure (creatinine < 30ml/min)
  • sever obstructive lung disease
  • have a pacemaker, cerebral aneurysm or metal prosthesis
  • evidence of disease relapse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689182

Locations
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3h 2Y9
Sponsors and Collaborators
Andrea Kew
Investigators
Principal Investigator: Andrea Kew, MD QEII Health Sciences Centre
  More Information

No publications provided

Responsible Party: Andrea Kew, Dr., Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT00689182     History of Changes
Other Study ID Numbers: CDHA017
Study First Received: May 30, 2008
Last Updated: February 19, 2013
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
iron reduction
iron overload
phlebotomy
hematopoietic stem cell transplant

Additional relevant MeSH terms:
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 19, 2014