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

June 29, 2022 updated by: Prof. Dr. med. Wolfgang Bethge

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, D-55101
        • Hematology/Oncology Medical Center University Hospital of Mainz
      • Nuernberg, Germany, D-90419
        • Bone Marrow Transplantation Unit Medical Center University Hospital of Nuernberg
      • Tuebingen, Germany, D-72076
        • Department of Hematology/Oncology Medical Center University Hospital of Tuebingen
      • Wiesbaden, Germany, D-65191
        • BMT-Unit Deutsche Klinik für Diagnostik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Treatment related mortality
Time Frame: 12 months after HCT
12 months after HCT
Treatment related mortality
Time Frame: 24 months after HCT
24 months after HCT

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Toxicity according CTC of protocol on day 100
Time Frame: on day 100
on day 100
Engraftment on day 100
Time Frame: on day 100
on day 100
Overall survival
Time Frame: 12 months after HCT
12 months after HCT
Incidence of graft versus host disease
Time Frame: 3 months after HCT
3 months after HCT
Incidence of infections
Time Frame: 2 years after HCT
2 years after HCT
Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells
Time Frame: 3 months after HCT
3 months after HCT
Overall survival
Time Frame: 24 months after HCT
24 months after HCT
Incidence of graft versus host disease
Time Frame: 6 months after HCT
6 months after HCT
Disease free survival
Time Frame: 24 months after HCT
24 months after HCT
Disease response
Time Frame: 12 months after HCT
12 months after HCT
Disease response
Time Frame: 24 months after HCT
24 months after HCT
Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells
Time Frame: 6 months after HCT
6 months after HCT
Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells
Time Frame: 12 months after HCT
12 months after HCT
Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells
Time Frame: 24 months after HCT
24 months after HCT
Incidence of graft versus host disease
Time Frame: 12 months after HCT
12 months after HCT
Incidence of graft versus host disease
Time Frame: 24 months after HCT
24 months after HCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof. Dr. med. Wolfgang Bethge

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer
medac GmbH
Neovii Biotech

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wolfgang A Bethge, MD, Medical Center University Hospital of Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E:531/2011
  • 2011-002192-41 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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