Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multicenter Study of Peritransplantation Immunosuppression for Mismatched Hematopoietic Cell Transplantation After Reduced Intensity Conditioning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01582048
Recruitment Status : Terminated (slow enrollment)
First Posted : April 20, 2012
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
medac GmbH
Pfizer
Neovii Biotech
Information provided by (Responsible Party):
Prof. Dr. med. Wolfgang Bethge, University Hospital Tuebingen

Tracking Information
First Submitted Date  ICMJE April 16, 2012
First Posted Date  ICMJE April 20, 2012
Last Update Posted Date May 8, 2018
Study Start Date  ICMJE April 2012
Actual Primary Completion Date August 17, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
  • Treatment related mortality [ Time Frame: 12 months after HCT ]
  • Treatment related mortality [ Time Frame: 24 months after HCT ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01582048 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
  • Toxicity according CTC of protocol on day 100 [ Time Frame: on day 100 ]
  • Engraftment on day 100 [ Time Frame: on day 100 ]
  • Overall survival [ Time Frame: 12 months after HCT ]
  • Incidence of graft versus host disease [ Time Frame: 3 months after HCT ]
  • Incidence of infections [ Time Frame: 2 years after HCT ]
  • Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells [ Time Frame: 3 months after HCT ]
  • Overall survival [ Time Frame: 24 months after HCT ]
  • Incidence of graft versus host disease [ Time Frame: 6 months after HCT ]
  • Disease free survival [ Time Frame: 24 months after HCT ]
  • Disease response [ Time Frame: 12 months after HCT ]
  • Disease response [ Time Frame: 24 months after HCT ]
  • Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells [ Time Frame: 6 months after HCT ]
  • Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells [ Time Frame: 12 months after HCT ]
  • Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells [ Time Frame: 24 months after HCT ]
  • Incidence of graft versus host disease [ Time Frame: 12 months after HCT ]
  • Incidence of graft versus host disease [ Time Frame: 24 months after HCT ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicenter Study of Peritransplantation Immunosuppression for Mismatched Hematopoietic Cell Transplantation After Reduced Intensity Conditioning
Official Title  ICMJE Multicenter Phase II Study of Peritransplantation Immunosuppression Using ATG, Rituximab, Sirolimus and Mycophenolate Mofetil in Patient Receiving Mismatched Hematopoietic Cell Transplantation After Reduced Intensity Conditioning With Fludarabine and Treosulfan
Brief Summary Feasibility and toxicity of peritransplantation immunosuppression with ATG, sirolimus, mycophenolate mofetil and rituximab in patients receiving mismatched allogeneic HCT after a reduced intensity conditioning regimen with fludarabine/treosulfan
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Patients Receiving Mismatched Allogeneic HCT
Intervention  ICMJE Drug: immunosuppression
Conditioning with treosulfan 14 g/m2 day -6 to -4, fludarabine 30 mg/m2/24h day-6 to -2, ATG-Fresenius 20 mg/kg day -4 to -2, rituximab 500 mg/m2 day -1. Unmanipulated PBSC day 0. Postgrafting immunosuppression with mycophenolate mofetil (15 mg/kg TID) and sirolimus (2 mg QD).
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 2, 2018)
9
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2012)
60
Actual Study Completion Date  ICMJE August 17, 2016
Actual Primary Completion Date August 17, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients scheduled for mismatched allogeneic HCT
  • Unrelated donor with maximal 2 antigen or allelic mismatches in HLA-I or HLA-II
  • Age >=75, >=18 years
  • Patients Age <=50 if a HCT-CI score > 2 [acc. to Sorror et al., 2005]
  • Karnofsky Index >60%
  • Patients with:

    • Acute myeloid leukemia in CR (<5% blasts)
    • Acute lymphoblastic leukemia in CR (< 5% blasts)
    • Myelodysplastic syndrome with up to 20% blasts
    • Osteomyelofibrosis
    • Chronic lymphocytic leukemia
    • High grade Non-Hodgkin Lymphoma in CR or PR
    • Low grad Non-Hodgkin Lymphoma in CR or PR
    • M. Hodgkin in CR or PR
    • Chronic myeloid leukaemia in chronic phase or CR of blast crisis

Exclusion Criteria:

  • Patients with >5% blasts in BM at the time of transplantation
  • Progressive or chemorefractory disease
  • Less than 3 months after preceding HCT
  • CNS involvement with disease
  • Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month.
  • Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminases higher 2x upper limit of normal.
  • Chronic active viral hepatitis
  • Ejection fraction <40 % on echocardiography
  • Patients with > grade II hypertension by CTC criteria
  • Creatinine clearance <50 ml/min
  • Proteinuria >800 mg/24 h
  • Respiratory failure necessitating supplemental oxygen or DLCO <30%
  • Allergy against murine antibodies
  • Known allergy/intolerance against sirolimus or one of it's excipients
  • HIV-Infection
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control during study treatment and for at least 12 months thereafter. (Women of childbearing potential must have a negative serum pregnancy test at study entry)
  • Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study
  • Patients with a history of psychiatric illness or condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction)
  • Patients unwilling or unable to comply with the protocol
  • Unable to give informed consent
  • Enrollment in an other trial interfering with the endpoints of this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01582048
Other Study ID Numbers  ICMJE E:531/2011
2011-002192-41 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. med. Wolfgang Bethge, University Hospital Tuebingen
Study Sponsor  ICMJE Prof. Dr. med. Wolfgang Bethge
Collaborators  ICMJE
  • medac GmbH
  • Pfizer
  • Neovii Biotech
Investigators  ICMJE
Principal Investigator: Wolfgang A Bethge, MD Medical Center University Hospital of Tuebingen
PRS Account University Hospital Tuebingen
Verification Date May 2018

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