A Phase 2 interventional study of 5-Azacitidine in Myelodysplastic Syndrome and Acute Myeloid Leukemia, sponsored by Heinrich-Heine University, Duesseldorf. Completed at 6 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-23.
Sponsored by Heinrich-Heine University, Duesseldorf · Phase 2, Interventional, and Treatment
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.
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, which may be the result of poor differentiation of the leukemic cells. The study drug 5-Aza is effective in AML and MDS.In addition to direct cytotoxicity, it alters gene expression and induces differentiation of leukemic blast cells. Furthermore, DNA-demethylating treatment results in an induction of transcription and cell surface expression of formerly unexpressed KIRs (killer Ig-like receptors) in NK cells, which are involved in the specific recognition of leukemic target cells and who are able to generate a specific graft-versus leukemia effect. The increased expression of MHC class I and II molecules on the surface of the recipient's leukemic cells and the de novo expression of formerly silenced KIR genes in donor NK cells due to treatment with 5-Aza may result in an increased susceptibility of myeloid leukemic cells to the allogeneic graft versus leukemia effect. Therefore, the graft-versus leukemia effect by donor lymphocyte infusions and NK cells from the original donor may be supported by additional therapy with 5-Azacitidine.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 30 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Heinrich-Heine University, Duesseldorf is the lead sponsor of 174 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
5-Azacitidine in addition to standard donor lymphocyte infusions.
Drug: 5-Azacitidine
5-Aza will be administered at doses of 100mg/m2 via subcutaneous injection over a period of 5 days. The total amount per treatment cycle, consisting of 5 days, is 500mg/m². Each treatment cycle is repeated every 28 days, with a treatment pause of 23 days between each 5-Aza cycle, to a total of 6 (optional 8 cycles) cycles. DLI will be transfused on day +34 with a total count of CD3+ cells of DLI 1-5x10E6CD3+/kg bodyweight. In absence of GvHD DLI transfusion is repeated on day +90 with DLI 1-5x10E7CD3+/kg bodyweight and on day +142 with DLI 1-5x10E8CD3+/kg bodyweight. Additional DLI may be given.
Also known as: Vidaza
Best response
Time frame: within the 6 months of treatment
Safety and Toxicity of 5-Azacitidine for patients relapsing after allo-SCT
Time frame: within 3 years
Response rate
Time frame: within 6 months
Duration of remissions
Time frame: within 3 years
Incidence of acute and chronic GvHD
Time frame: 3 years
Achievement of complete chimerism
Time frame: 6 month
Toxicity
Time frame: wtihin 3 years
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Heinrich-Heine University, Duesseldorf