Safety Study of Calcineurin Inhibitor Free GvHD Prophylaxis in Allogeneic Stem Cell Transplantation

Everolimus and Mycophenolate Sodium as GvHD Prophylaxis in Allogeneic Stem Cell Transplantation

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00856505

Enrollment

Registered

2009-03-05

Start date

2008-03-31

Completion date

2011-03-31

Last updated

2009-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Diseases

Keywords

Hematopoietic Stem Cell Transplantation, Drug Therapy, Combination, Immunosuppression

Brief summary

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.

Interventions

DRUGEverolimus and mycophenolate sodium

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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: * plasmocytoma * immunocytoma (M. Waldenström) * chronic-lymphatic leukemia (CLL) * additional low and high grade Non-Hodgkin Lymphoma * Hodgkins disease * HLA-matched (HLA-A, -B, -DRB1) related or unrelated donor available * Signed informed consent

Exclusion criteria

* CNS involvement by underlying disease * Pulmonary disease with VC \< 55%, DLCO \< 40% * Cardiac ejection fraction \< 30%, uncontrollable arrhythmia * Creatinin \> 1,5 mg/dl or Creatinin-Clearance \< 30 ml/min * Bilirubin \> 2 mg/dl * Active Hepatitis B or C * HIV serologic positive * Pregnancy and lactation * Pre-menstrual women without medical safe contraception * Participation on another clinical trial in between 30 days before start or during the study only if the clinical trial interferes with the outcome measures. * Known allergy to study medication or ingredients of the formulation * Drug- or alcohol abuse * Non-compliance

Design outcomes

Primary

Measure	Time frame
Toxicity according to CTCAE v3.0	after 100 days and one year after treatment start

Secondary

Measure	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	Day 100 and one year after stem cell transplantation
Overall survival	day 100 and one year after stem cell transplantation

Countries

Germany

Contacts

Primary ContactReinhard Marks, MD

reinhard.marks@uniklinik-freiburg.de49-761-270-

Backup ContactJuergen Finke, MD

juergen.finke@uniklinik-freiburg.de49-761-270-

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026