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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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 transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heinrich-Heine University, Duesseldorf
• Treatments: Azacitidine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.