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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
  Purpose

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.


Condition Intervention Phase
Hematologic Diseases
 Drug: Everolimus and mycophenolate sodium
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Everolimus and Mycophenolate Sodium as GvHD Prophylaxis in Allogeneic Stem Cell Transplantation

Resource links provided by NLM:

MedlinePlus related topics: Blood Disorders
U.S. FDA Resources

Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Toxicity according to CTCAE v3.0 [ Time Frame: after 100 days and one year after treatment start ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 38
Study Start Date: March 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus and mycophenolate sodium
Combination of experimental immunosuppressants for GvHD prophylaxis
 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856505

Contacts
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

Locations
Germany
University Medical Center, Division Hematology/Oncology Recruiting
Freiburg, Baden-Wuerttemberg, Germany, 79104
Contact: Reinhard Marks, MD     49-761-270 ext 3278     reinhard.marks@uniklinik-freiburg.de    
Sub-Investigator: Reinhard Marks, MD            
Principal Investigator: Juergen Finke, MD            
Sponsors and Collaborators
University Hospital Freiburg
Investigators
Principal Investigator: Juergen Finke, MD University Medical Center Freiburg, Div. Hematology/Oncology
Study Director: Reinhard Marks, MD University Medical Center Freiburg, Div. Hematology/Oncology
  More Information

No publications provided

Responsible Party: Prof. Jürgen Finke, University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT00856505     History of Changes
Other Study ID Numbers: 00557
Study First Received: March 4, 2009
Last Updated: March 4, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Freiburg:
Hematopoietic Stem Cell Transplantation
Drug Therapy, Combination
Immunosuppression

Additional relevant MeSH terms:
Hematologic Diseases
Mycophenolic Acid
Sirolimus
Mycophenolate mofetil
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 27, 2012