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

Sponsor
Prof. Dr. med. Wolfgang Bethge (Other)
Overall Status
Terminated
CT.gov ID
NCT01582048
Collaborator
medac GmbH (Industry), Pfizer (Industry), Neovii Biotech (Industry)
9
Enrollment
4
Locations
52.5
Duration (Months)
2.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Aug 17, 2016
Actual Study Completion Date :
Aug 17, 2016

Outcome Measures

Primary Outcome Measures

  1. Treatment related mortality [12 months after HCT]

  2. Treatment related mortality [24 months after HCT]

Secondary Outcome Measures

  1. Toxicity according CTC of protocol on day 100 [on day 100]

  2. Engraftment on day 100 [on day 100]

  3. Overall survival [12 months after HCT]

  4. Incidence of graft versus host disease [3 months after HCT]

  5. Incidence of infections [2 years after HCT]

  6. Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells [3 months after HCT]

  7. Overall survival [24 months after HCT]

  8. Incidence of graft versus host disease [6 months after HCT]

  9. Disease free survival [24 months after HCT]

  10. Disease response [12 months after HCT]

  11. Disease response [24 months after HCT]

  12. Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells [6 months after HCT]

  13. Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells [12 months after HCT]

  14. Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells [24 months after HCT]

  15. Incidence of graft versus host disease [12 months after HCT]

  16. Incidence of graft versus host disease [24 months after HCT]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
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

    1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hematology/Oncology Medical Center University Hospital of Mainz Mainz Germany D-55101
2 Bone Marrow Transplantation Unit Medical Center University Hospital of Nuernberg Nuernberg Germany D-90419
3 Department of Hematology/Oncology Medical Center University Hospital of Tuebingen Tuebingen Germany D-72076
4 BMT-Unit Deutsche Klinik für Diagnostik Wiesbaden Germany D-65191

Sponsors and Collaborators

  • Prof. Dr. med. Wolfgang Bethge
  • medac GmbH
  • Pfizer
  • Neovii Biotech

Investigators

  • Principal Investigator: Wolfgang A Bethge, MD, Medical Center University Hospital of Tuebingen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Prof. Dr. med. Wolfgang Bethge, Associate Professor Hematology/Oncology, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01582048
Other Study ID Numbers:
  • E:531/2011
  • 2011-002192-41
First Posted:
Apr 20, 2012
Last Update Posted:
Jul 5, 2022
Last Verified:
Jun 1, 2022

Study Results

No Results Posted as of Jul 5, 2022