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

Primary Purpose

Hematologic Diseases

Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Everolimus and mycophenolate sodium
Sponsored by
University Hospital Freiburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Diseases focused on measuring Hematopoietic Stem Cell Transplantation, Drug Therapy, Combination, Immunosuppression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Medical Center, Division Hematology/OncologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Everolimus and mycophenolate sodium

Arm Description

Combination of experimental immunosuppressants for GvHD prophylaxis

Outcomes

Primary Outcome Measures

Toxicity according to CTCAE v3.0

Secondary Outcome Measures

Hematopoietic engraftment
Incidence of acute and chronic GvHD
Progression free survival
Overall survival

Full Information

First Posted
March 4, 2009
Last Updated
March 4, 2009
Sponsor
University Hospital Freiburg
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1. Study Identification

Unique Protocol Identification Number
NCT00856505
Brief Title
Safety Study of Calcineurin Inhibitor Free GvHD Prophylaxis in Allogeneic Stem Cell Transplantation
Official Title
Everolimus and Mycophenolate Sodium as GvHD Prophylaxis in Allogeneic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Freiburg

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Diseases
Keywords
Hematopoietic Stem Cell Transplantation, Drug Therapy, Combination, Immunosuppression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Everolimus and mycophenolate sodium
Arm Type
Experimental
Arm Description
Combination of experimental immunosuppressants for GvHD prophylaxis
Intervention Type
Drug
Intervention Name(s)
Everolimus and mycophenolate sodium
Intervention Description
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
Primary Outcome Measure Information:
Title
Toxicity according to CTCAE v3.0
Time Frame
after 100 days and one year after treatment start
Secondary Outcome Measure Information:
Title
Hematopoietic engraftment
Time Frame
day 30 after stem cell transplantation
Title
Incidence of acute and chronic GvHD
Time Frame
one year after stem cell transplantation
Title
Progression free survival
Time Frame
Day 100 and one year after stem cell transplantation
Title
Overall survival
Time Frame
day 100 and one year after stem cell transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reinhard Marks, MD
Phone
49-761-270-
Ext
3278
Email
reinhard.marks@uniklinik-freiburg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Juergen Finke, MD
Phone
49-761-270-
Ext
3408
Email
juergen.finke@uniklinik-freiburg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juergen Finke, MD
Organizational Affiliation
University Medical Center Freiburg, Div. Hematology/Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Reinhard Marks, MD
Organizational Affiliation
University Medical Center Freiburg, Div. Hematology/Oncology
Official's Role
Study Director
Facility Information:
Facility Name
University Medical Center, Division Hematology/Oncology
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79104
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reinhard Marks, MD
Phone
49-761-270
Ext
3278
Email
reinhard.marks@uniklinik-freiburg.de
First Name & Middle Initial & Last Name & Degree
Reinhard Marks, MD
First Name & Middle Initial & Last Name & Degree
Juergen Finke, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33755792
Citation
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.
Results Reference
derived

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

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