Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00003773

Trial Description

start of 1:1-Block title

Title

An Open-label, Uncontrolled, Multicenter, Multinational Study on the Efficacy and Safety of Administration of Donor Lymphocytes Depleted of Alloreactive T-cells (ATIR), Through the Use of TH9402 and Light Treatment in an ex Vivo Process, in Patients Receiving a CD34-selected Peripheral Blood Stem Cell Graft From a Related, Haploidentical Donor

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The purpose of this study is to determine whether the administration of a donor lymphocyte
preparation depleted of functional host alloreactive T-cells (ATIR) after a T-cell depleted
stem cell transplant from a related, haploidentical donor enhances survival by improving the
immune effect against infections while preventing graft-versus-host disease .

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Allogeneic stem cell transplantation is the treatment of choice for many patients with
leukemia and other hematologic malignancies. However, a major limitation of this therapy is
that for a significant number of patients no fully HLA-matched donor can be found. The
application of partially HLA-matched (haploidentical) family donors, who are virtually
always available, has some complications. If there is no T-cell add-back it increases the
risk for life-threatening infections and disease relapse, while in case of T-cell add-back
the risk for graft-versus-host disease is raised.

Kiadis Pharma has developed a method to selectively deplete host alloreactive T-cells
through photodynamic therapy, using TH9402 ex vivo. The donor lymphocyte preparation
depleted of functional host alloreactive T-cells (ATIR) is administered to the patient 28-42
days after the stem cell transplant.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003773
  •   2012/05/04
  •   2009/08/26
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2008-008198-73 
  •   NCT00967343  (ClinicalTrials.gov)
  •   CR-AIR-004  (Kiadis Pharma)
  •   EudraCT no. 2008-008198-73 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Myeloid Leukemia
  •   Lymphoblastic Leukemia
  •   Lymphoma
  •   Multiple Myeloma
  •   Myelodysplastic Syndrome
  •   Myeloproliferative Disorders
  •   C90.0 -  Multiple myeloma
  •   C92.0 -  Acute myeloid leukaemia
  •   C91.1 -  Chronic lymphocytic leukaemia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Biological: Donor lymphocyte preparation depleted of host functional alloreactive T-cells
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   II-III
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Transplant related mortality; time frame: 6 and 12 months after the transplantation

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Incidence and severity of acute and chronic graft-versus-host disease; time frame: Up to 24 months after the transplantation
- Progression free survival; time frame: Up to 24 months after the transplantation
- Incidence and severity of bacterial, viral or fungal infection; time frame: Up to 24 months after the transplantation
- Immune reconstitution; time frame: Up to 24 months after the transplantation
- Health status (including Quality of Life); time frame: Up to 24 months after the transplantation
- Overall survival; time frame: Up to 24 months after the transplantation

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   United States
  •   Belgium
  •   Canada
  •   Germany
  •   Italy
  •   Netherlands
  •   United Kingdom
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2009/08/31
  •   70
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

One of the following hematological malignancies:

- Acute Myeloid Leukemia (AML)

- Acute Lymphoblastic Leukemia (ALL)

- Myelodysplastic Syndrome (MDS)

- Ph-positive chronic myeloid leukemia (CML)

- Non-Hodgkin Lymphoma (NHL)

- Myelodysplastic Syndrome (MDS)

- Chronic Myeloid Leukemia (CML)

- Multiple Myeloma (MM)

- Chronic Lymphocytic Leukemia (CLL)

- Myeloproliferative Syndrome (MPS)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- AML in 1st complete remission with good risk karyotypes

- MM featuring concurrent extramedullar disease or being non-responsive to prior
therapy

- CML in blast crisis

- CLL concurrently transformed into high-grade lymphoma and failing to demonstrate at
least partial remission

- NHL with concurrent bulky disease (≥ 5 cm)

- Diffusing Capacity for Carbon Monoxide (DLCO) < 40% predicted

- Left ventricular ejection fraction < 40%

- AST/SGOT > 2.5 x ULN

- Bilirubin > 1.5 x ULN

- Creatinine > 1.5 x ULN

- HIV positive

- Positive pregnancy test for women of childbearing age

- Prior haploidentical peripheral blood stem cell or cord blood transplantation

- Less than 2 years from a prior allogeneic stem cell transplantation

- Estimated probability of surviving less than three months

- Major anticipated illness or organ failure incompatible with survival from transplant

- Severe psychiatric illness or mental deficiency sufficiently severe as to make
compliance with the transplant treatment unlikely and informed consent impossible

- Known allergy to any of the components of ATIR

- Any other condition which, in the opinion of the investigator, makes the patient
ineligible for the study

Donor Inclusion Criteria:

- Haploidentical family donor with 2 to 3 mismatches at the HLA-A, -B and/or DR loci of
the unshared haplotype.

- Male or female, age ≥ 16, ≤ 75 years.

- Donors must be fit to receive G-CSF and undergo apheresis (normal blood count,
normotensive and no history of stroke).

- Donor must have Eastern Cooperative Oncology Group (ECOG) performance status of 2 or
less.

- Donor must provide written informed consent.

Donor Exclusion Criteria:

- Medically uncontrolled coronary heart disease.

- Myocardial infarction within the last 3 months.

- History of uncontrolled seizures.

- History of malignancy (except basal cell or squamous carcinoma of the skin, positive
PAP smear and subsequent negative follow up).

- Positive test result for any of the mandatory viral tests in the applicable region,
except for a positive cytomegalovirus (CMV) result, which does not lead to exclusion.

- Presence of a transmissible disease (such as HIV positive), a major illness, a
suspected systemic dysfunction and/or an active inflammatory or autoimmune disorder.

- Female donors who are pregnant or nursing.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Kiadis Pharma
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Julius Maximilian University of Würzburg, Germany
    • Stephan Mielke, MD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Julius Maximilian University of Würzburg, Germany
    • Stephan Mielke, MD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting stopped after recruiting started
  •   2012/02/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   8
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.