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

Sponsor

Technische Universität Dresden (Other)

Overall Status

Completed

CT.gov ID

NCT00422890

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myeloid Leukemia Myelodysplastic Syndrome	Drug: 5-Azacytidin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Dec 1, 2009

Outcome Measures

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. [4 months]

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. [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00422890

Other Study ID Numbers:

TUD-RELAZA-008
2006-001040-31 (EudraCT Nr.)

First Posted:

Jan 17, 2007

Last Update Posted:

Jul 11, 2011

Last Verified:

Jul 1, 2011

Keywords provided by , ,

Acute myeloid leukaemia or Myelodysplastic syndrome

Additional relevant MeSH terms:

Leukemia, Myeloid

Preleukemia

Myelodysplastic Syndromes

Study Results

No Results Posted as of Jul 11, 2011