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

NCT01582048 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-07-05

No results posted yet for this study

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

Conditions

  • Patients Receiving Mismatched Allogeneic HCT

Interventions

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).

Sponsors & Collaborators

  • medac GmbH

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Neovii Biotech

    collaborator INDUSTRY

  • Prof. Dr. med. Wolfgang Bethge

    lead OTHER

Principal Investigators

  • Wolfgang A Bethge, MD · Medical Center University Hospital of Tuebingen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2016-08-17
Completion
2016-08-17

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01582048 on ClinicalTrials.gov