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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University Hospital Freiburg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00856505
First received: March 4, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted

March 4, 2009
March 4, 2009
March 2008
March 2010   (final data collection date for primary outcome measure)
Toxicity according to CTCAE v3.0 [ Time Frame: after 100 days and one year after treatment start ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • Hematopoietic engraftment [ Time Frame: day 30 after stem cell transplantation ] [ Designated as safety issue: Yes ]
  • Incidence of acute and chronic GvHD [ Time Frame: one year after stem cell transplantation ] [ Designated as safety issue: Yes ]
  • Progression free survival [ Time Frame: Day 100 and one year after stem cell transplantation ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: day 100 and one year after stem cell transplantation ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hematologic Diseases
Drug: Everolimus 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
Experimental: Everolimus and mycophenolate sodium
Combination of experimental immunosuppressants for GvHD prophylaxis
Intervention: Drug: Everolimus and mycophenolate sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
38
March 2011
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Reinhard Marks, MD 49-761-270- ext 3278 reinhard.marks@uniklinik-freiburg.de
Contact: Juergen Finke, MD 49-761-270- ext 3408 juergen.finke@uniklinik-freiburg.de
Germany
 
NCT00856505
00557
Yes
Prof. Jürgen Finke, University Hospital Freiburg
University Hospital Freiburg
Not Provided
Principal Investigator: Juergen Finke, MD University Medical Center Freiburg, Div. Hematology/Oncology
Study Director: Reinhard Marks, MD University Medical Center Freiburg, Div. Hematology/Oncology
University Hospital Freiburg
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP