NCT01582048

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2012

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
terminated

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

April 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2016

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

4.4 years

First QC Date

April 16, 2012

Last Update Submit

June 29, 2022

Conditions

Patients Receiving Mismatched Allogeneic HCT

Outcome Measures

Primary Outcomes (2)

  • Treatment related mortality

    12 months after HCT

  • Treatment related mortality

    24 months after HCT

Secondary Outcomes (16)

  • Toxicity according CTC of protocol on day 100

    on day 100

  • Engraftment on day 100

    on day 100

  • Overall survival

    12 months after HCT

  • Incidence of graft versus host disease

    3 months after HCT

  • Incidence of infections

    2 years after HCT

  • +11 more secondary outcomes

Interventions

immunosuppressionDRUG

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).

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hematology/Oncology Medical Center University Hospital of Mainz

Mainz, D-55101, Germany

Location

Bone Marrow Transplantation Unit Medical Center University Hospital of Nuernberg

Nuremberg, D-90419, Germany

Location

Department of Hematology/Oncology Medical Center University Hospital of Tuebingen

Tübingen, D-72076, Germany

Location

BMT-Unit Deutsche Klinik für Diagnostik

Wiesbaden, D-65191, Germany

Location

Related Links

MeSH Terms

Interventions

Immunosuppression Therapy

Intervention Hierarchy (Ancestors)

ImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Wolfgang A Bethge, MD

    Medical Center University Hospital of Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor Hematology/Oncology

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 20, 2012

Study Start

April 1, 2012

Primary Completion

August 17, 2016

Study Completion

August 17, 2016

Last Updated

July 5, 2022

Record last verified: 2022-06

Locations

DE(4)