NCT00856505

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 5, 2009

Status Verified

March 1, 2009

Enrollment Period

2 years

First QC Date

March 4, 2009

Last Update Submit

March 4, 2009

Conditions

Hematologic Diseases

Keywords

Hematopoietic Stem Cell TransplantationDrug Therapy, CombinationImmunosuppression

Outcome Measures

Primary Outcomes (1)

  • Toxicity according to CTCAE v3.0

    after 100 days and one year after treatment start

Secondary Outcomes (4)

  • 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

Study Arms (1)

Everolimus and mycophenolate sodium

EXPERIMENTAL

Combination of experimental immunosuppressants for GvHD prophylaxis

Drug: Everolimus and mycophenolate sodium

Interventions

Everolimus and mycophenolate sodiumDRUG

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

Everolimus and mycophenolate sodium

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center, Division Hematology/Oncology

Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33755792DERIVED

MeSH Terms

Conditions

Hematologic Diseases

Interventions

EverolimusMycophenolic Acid

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Juergen Finke, MD

    University Medical Center Freiburg, Div. Hematology/Oncology

    PRINCIPAL INVESTIGATOR

  • Reinhard Marks, MD

    University Medical Center Freiburg, Div. Hematology/Oncology

    STUDY DIRECTOR

Central Study Contacts

Reinhard Marks, MD

CONTACT

49-761-270-reinhard.marks@uniklinik-freiburg.de

Juergen Finke, MD

CONTACT

49-761-270-juergen.finke@uniklinik-freiburg.de

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 5, 2009

Study Start

March 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2011

Last Updated

March 5, 2009

Record last verified: 2009-03

Locations

DE(1)