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Patients Receiving Mismatched Allogeneic HCTPhase 2NCT01582048

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

A Phase 2 study testing immunosuppression in people with Patients Receiving Mismatched Allogeneic HCT, run by Prof. Dr. med. Wolfgang Bethge at 4 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
immunosuppression
How many people
9 participants
Where
4 sitesGermany
Study dates
Apr 2012to 17 Aug 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 15Show fewer
  • 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

Who cannot join

  • 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.
Show all 21Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Hematology/Oncology Medical Center University Hospital of Mainz

    Mainz, D-55101

  • Bone Marrow Transplantation Unit Medical Center University Hospital of Nuernberg

    Nuremberg, D-90419

  • Department of Hematology/Oncology Medical Center University Hospital of Tuebingen

    Tübingen, D-72076

  • BMT-Unit Deutsche Klinik für Diagnostik

    Wiesbaden, D-65191

Other trials in Germany

About this study

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

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

Being tested
immunosuppression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment related mortality

    Measured: 12 months after HCT

  2. Treatment related mortality

    Measured: 24 months after HCT

Secondary outcomes (16)

  1. Toxicity according CTC of protocol on day 100

    Measured: on day 100

  2. Engraftment on day 100

    Measured: on day 100

  3. Overall survival

    Measured: 12 months after HCT

  4. Incidence of graft versus host disease

    Measured: 3 months after HCT

  5. Incidence of infections

    Measured: 2 years after HCT

  6. Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells

    Measured: 3 months after HCT

  7. Overall survival

    Measured: 24 months after HCT

  8. Incidence of graft versus host disease

    Measured: 6 months after HCT

  9. Disease free survival

    Measured: 24 months after HCT

  10. Disease response

    Measured: 12 months after HCT

  11. Disease response

    Measured: 24 months after HCT

  12. Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells

    Measured: 6 months after HCT

  13. Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells

    Measured: 12 months after HCT

  14. Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells

    Measured: 24 months after HCT

  15. Incidence of graft versus host disease

    Measured: 12 months after HCT

  16. Incidence of graft versus host disease

    Measured: 24 months after HCT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completion17 Aug 2016
  4. Study completion17 Aug 2016

Why it stopped: slow enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01582048
Sponsor's protocol ID
E:531/2011
Other IDs
2011-002192-41
Status last verified
Jun 2022
First submitted
16 Apr 2012
Last updated
5 Jul 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing immunosuppression in people with Patients Receiving Mismatched Allogeneic HCT, run by Prof. Dr. med. Wolfgang Bethge at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: slow enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment related mortality (time frame: 12 months after HCT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01582048.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.

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