Treatment of Imminent Haematological Relapse in Patients With AML and MDS Following Allogeneic Stem Cell Transplantation With 5-azacitidine (Vidaza®)

This study has been completed.
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00422890
First received: January 15, 2007
Last updated: July 8, 2011
Last verified: July 2011
  Purpose

Efficacy and safety of 5-Azacytidin in the treatment of the haematological relapse in patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling CD34-chimerism after hematopoietic stem cell transplantation.


Condition Intervention Phase
Myeloid Leukemia
Myelodysplastic Syndrome
Drug: 5-Azacytidin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Efficacy of 5-Azacytidin in the treatment of the haematological relapse in patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling CD34-chimerism after hematopoietic stem cell transplantation. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety of 5-Azacytidin in the treatment of the haematological relapse in patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling CD34-chimerism after hematopoietic stem cell transplantation. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: January 2007
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 5-Azacytidin
    in case of decreasing CD34 chimerism
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Screening phase:

  • Age > 18 years
  • Patients with CD34+ AML or MDS post-allogeneic HSCT
  • Written patient consent after consultation

Treatment phase

  • AML/MDS: donor chimerism < 80% in the CD34+ subpopulation following allogeneic HSCT in patients with CD34+ AML or MDS, but with no haematological relapse (blasts < 5% in bone marrow)
  • Leukocytes > 3 Gpt/l and platelets > 75 Gpt/l (transfusion-independent)

Exclusion Criteria:

  • Known intolerance to 5-azacitidine or mannitol
  • Uncontrollable infectious disease
  • Patients with active hepatitis B or C or HIV infection
  • Severe hepatic function impairment (ASAT and ALAT may not be above three times the normal value) or hepatic cirrhosis, or malignant hepatic tumour
  • Renal function impairment (creatinine > twice the normal value, creatinine clearance < 50 ml/min)
  • Pregnancy or lactation
  • Women of childbearing age, except for those who meet the following criteria:
  • postmenopausal (12 months natural amenorrhoea)
  • postoperative (6 weeks after bilateral ovarectomy with or without hysterectomy)
  • regular and correct use of a contraceptive method with an error rate < 1% per year (e.g. implants, depot injections, combined oral contraceptives, intrauterine device - IUD, whereby hormonal coils with a Pearl Index of < 1% are safer than copper coils)
  • sexual abstinence
  • Partner vasectomy
  • Men who do not use one of the following for contraception:
  • sexual abstinence
  • post vasectomy
  • condoms
  • Participation of the patient in a drug trial outside the indication of allogeneic transplantation up to four weeks before study initiation
  • Addictive or other illnesses that prevent the person concerned from comprehending the nature and impact, as well as potentical consequences of the clinical trial
  • Evidence that the patient may intentionally not comply with the protocol, e.g. lack of cooperation With the exception of a known allergic reaction or intolerance to 5-azacitidine, these criteria do not apply to the screening phase.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422890

Locations
Germany
University hospital Dresden, department of medicine
Dresden, Saxony, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Uwe Platzbecker, MD Univesity Hospital Dresden, department of medicine
  More Information

No publications provided

Responsible Party: MD Uwe Platzbecker, Dresden University of Technology
ClinicalTrials.gov Identifier: NCT00422890     History of Changes
Other Study ID Numbers: TUD-RELAZA-008, 2006-001040-31 (EudraCT Nr.)
Study First Received: January 15, 2007
Last Updated: July 8, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
Acute myeloid leukaemia or Myelodysplastic syndrome

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on April 14, 2014