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Clinical Trials/NCT01582048
NCT01582048TerminatedPhase 2

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

Prof. Dr. med. Wolfgang Bethge8 sites in 1 country9 target enrollmentStarted: April 1, 2012Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Sponsor
Enrollment
9
Locations
8
Primary Endpoint
Treatment related mortality
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Treatment related mortality

Time Frame: 24 months after HCT

Secondary Outcomes

  • Engraftment on day 100(on day 100)
  • Disease response(24 months after HCT)
  • Toxicity according CTC of protocol on day 100(on day 100)
  • Incidence of infections(2 years after HCT)
  • Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells(24 months after HCT)
  • Overall survival(24 months after HCT)
  • Incidence of graft versus host disease(24 months after HCT)
  • Disease free survival(24 months after HCT)

Investigators

Sponsor
Prof. Dr. med. Wolfgang Bethge
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Prof. Dr. med. Wolfgang Bethge

Associate Professor Hematology/Oncology

University Hospital Tuebingen

Study Sites (8)

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