Status:
COMPLETED
Safety Study of 5-Azacitidine and Standard Donor Lymphocyte Infusion (DLI) to Treat Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) Relapsing After Allogeneic Stem Cell Transplantation
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Conditions:
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This open label phase-II trial evaluates hematological response of an additional treatment with 5-Azacitidine to common DLI in patients with MDS or AML relapsing after allogeneic stem cell transplanta...
Detailed Description
Relapse after allogeneic stem cell transplantation is a major problem in patients with poor prognosis AML or MDS. Donor lymphocyte infusions alone re-induce remission in a minority of these patients, ...
Eligibility Criteria
Inclusion
- \- Primary and secondary MDS, AML after MDS, and de novo AML relapsing after allogeneic stem cell transplantation
- Eligibility for Donor Lymphocyte Infusions
- Performance status according to the WHO scale: 0, 1 or 2.
- Adequate renal and liver function: bilirubin \< 1.5 times the upper limit of normal and a GFR \> 50 ml/min
- Absence of severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease, where New-York Heart Association (NYHA)
- HIV negative and HBs-Ag negative.
- Absence of active uncontrolled infection (Septicaemia).
- No prior history or current evidence of central nervous system and psychiatric disorders requiring hospitalization.
- Age at least 18 years.
- Negative pregnancy test for women with reproductive potential.
- Signed written informed consent must be given according to national/local regulations.
Exclusion
- \- Have malignant hepatic tumors.
- Severe liver dysfunction CHILD B and C.
- Renal insufficiency with a GFR \< 50 ml/min
- Radiation therapy, chemotherapy, or cytotoxic therapy, given to treat conditions other than MDS, AML or applied for conditioning prior allogeneic stemcell transplantation.
- Psychiatric illness that would prevent granting of informed consent.
- Treatment with androgenic hormones during the previous 14 days prior Day 1.
- Active viral infection with known human immunodeficiency virus (HIV) or viral Hepatitis B or C.
- Hypersensitivity to Mannitol or 5-Azacitidine.
- Treatment with other investigational drugs following relapse after allogeneic stemcell transplantation or ongoing adverse events from previous treatment with investigational drugs regardless of time period.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00795548
Start Date
November 1 2008
End Date
August 1 2011
Last Update
January 23 2012
Active Locations (6)
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1
Universitaetsklinik Heidelberg, Medizinische Klinik und Poliklinik V
Heidelberg, Baden-Wurttemberg, Germany, 69120
2
Bone Marrow Transplantation Unit, University Hospital Hamburg-Eppendorf
Hamburg, Hamburg, Germany, 20246
3
Klinikum der Johann-Wolfgang-Goethe Universität, Medizinische Klinik II
Frankfurt am Main, Hesse, Germany, 60590
4
Department of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40225