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In stem cell transplantation as treatment for malignant diseases, calcineurin inhibitors like cyclosporine A are commonly used to prevent tissue destruction (GvHD) by activated donor immune cells. The hypothesis for this study is, that replacing calcineurin inhibitors by everolimus and mycophenolate as GvHD prophylaxis not only reduces toxicity of the treatment but also improves tolerance induction of the donor T cells toward the host, eventually increasing the safety of stem cell transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus and mycophenolate sodium | Experimental | Combination of experimental immunosuppressants for GvHD prophylaxis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus and mycophenolate sodium | Drug | Everolimus tablets, 1.5mg/day bid, dosage adjusted to plasma levels Mycophenolate sodium, 720mg/day bid Duration: Mycophenolate tapering starts at day 56 after stem cell transplantation Everolimus tapering starts at day 100 after stem cell transplantation if no GvHD evident |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity according to CTCAE v3.0 | after 100 days and one year after treatment start |
| Measure | Description | Time Frame |
|---|---|---|
| Hematopoietic engraftment | day 30 after stem cell transplantation | |
| Incidence of acute and chronic GvHD | one year after stem cell transplantation | |
| Progression free survival |
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Inclusion Criteria:
Diagnosis of hematologic malignancies, indicated for allogeneic stem cell transplantation:
acute myeloid leukemia (AML), in CR1, ≥ CR2, primary refractory, relapse
chronic myeloid leukemia (CML), in chronic phase, in acceleration or blast crisis
myelodysplastic syndrome (MDS), RA/RARS (transfusion dependent), RAEB, RAEB-t and CMML
Lymphoma:
Hodgkins disease
HLA-matched (HLA-A, -B, -DRB1) related or unrelated donor available
Signed informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reinhard Marks, MD | Contact | 49-761-270- | 3278 | reinhard.marks@uniklinik-freiburg.de |
| Juergen Finke, MD | Contact | 49-761-270- | 3408 | juergen.finke@uniklinik-freiburg.de |
| Name | Affiliation | Role |
|---|---|---|
| Juergen Finke, MD | University Medical Center Freiburg, Div. Hematology/Oncology | Principal Investigator |
| Reinhard Marks, MD | University Medical Center Freiburg, Div. Hematology/Oncology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center, Division Hematology/Oncology | Recruiting | Freiburg im Breisgau | Baden-Wurttemberg | 79104 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33755792 | Derived | Schafer H, Blumel-Lehmann J, Ihorst G, Bertz H, Wasch R, Zeiser R, Finke J, Marks R. A prospective single-center study on CNI-free GVHD prophylaxis with everolimus plus mycophenolate mofetil in allogeneic HCT. Ann Hematol. 2021 Aug;100(8):2095-2103. doi: 10.1007/s00277-021-04487-y. Epub 2021 Mar 23. |
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| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 |
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|
| Day 100 and one year after stem cell transplantation |
| Overall survival | day 100 and one year after stem cell transplantation |
| Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |