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:
Dresden University of Technology
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00422890
First received: January 15, 2007
Last updated: July 8, 2011
Last verified: July 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Dresden University of Technology:
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
Dresden University of Technology
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 Dresden University of Technology:
|
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 May 23, 2013