NCT00422890

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_3

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

January 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

July 11, 2011

Status Verified

July 1, 2011

Enrollment Period

2.9 years

First QC Date

January 15, 2007

Last Update Submit

July 8, 2011

Conditions

Myeloid LeukemiaMyelodysplastic Syndrome

Keywords

Acute myeloid leukaemia or Myelodysplastic syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 months

Secondary Outcomes (1)

  • 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.

    4 months

Interventions

5-AzacytidinDRUG

in case of decreasing CD34 chimerism

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Dresden, department of medicine

Dresden, Saxony, 01307, Germany

Location

Related Publications (1)

  • Colbers A, Best B, Schalkwijk S, Wang J, Stek A, Hidalgo Tenorio C, Hawkins D, Taylor G, Kreitchmann R, Burchett S, Haberl A, Kabeya K, van Kasteren M, Smith E, Capparelli E, Burger D, Mirochnick M; PANNA Network and the IMPAACT 1026 Study Team. Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women. Clin Infect Dis. 2015 Nov 15;61(10):1582-9. doi: 10.1093/cid/civ587. Epub 2015 Jul 22.

    PMID: 26202768DERIVED

MeSH Terms

Conditions

Leukemia, MyeloidMyelodysplastic SyndromesLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Study Officials

  • Uwe Platzbecker, MD

    Univesity Hospital Dresden, department of medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 15, 2007

First Posted

January 17, 2007

Study Start

January 1, 2007

Primary Completion

December 1, 2009

Last Updated

July 11, 2011

Record last verified: 2011-07

Locations

DE(1)