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Trial record 1 of 1 for:    NCT00967343
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Efficacy and Safety of a Donor Lymphocyte Preparation Depleted of Functional Host Alloreactive T-cells (ATIR) in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor

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ClinicalTrials.gov Identifier: NCT00967343
Recruitment Status : Terminated
First Posted : August 27, 2009
Last Update Posted : April 1, 2013
Sponsor:
Information provided by (Responsible Party):
Kiadis Pharma

Tracking Information
First Submitted Date  ICMJE August 26, 2009
First Posted Date  ICMJE August 27, 2009
Last Update Posted Date April 1, 2013
Study Start Date  ICMJE August 2009
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2009)
Transplant related mortality [ Time Frame: 6 and 12 months after the transplantation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00967343 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2009)
  • Incidence and severity of acute and chronic graft-versus-host disease [ Time Frame: Up to 24 months after the transplantation ]
  • Progression free survival and overall 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of a Donor Lymphocyte Preparation Depleted of Functional Host Alloreactive T-cells (ATIR) in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor
Official Title  ICMJE 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
Brief Summary 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 .
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Myeloid Leukemia
  • Lymphoblastic Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Myelodysplastic Syndrome
  • Myeloproliferative Disorders
Intervention  ICMJE Biological: Donor lymphocyte preparation depleted of host functional alloreactive T-cells
Single intravenous infusion with 2x10E6 T-cells/kg
Study Arms  ICMJE Experimental: ATIR
Intervention: Biological: Donor lymphocyte preparation depleted of host functional alloreactive T-cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 24, 2012)
40
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2009)
70
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Germany,   Italy,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00967343
Other Study ID Numbers  ICMJE CR-AIR-004
EudraCT no. 2008-008198-73
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kiadis Pharma
Study Sponsor  ICMJE Kiadis Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Stephan Mielke, MD Julius Maximilian University of Würzburg, Germany
Study Chair: Denis-Claude Roy, MD Maisonneuve-Rosemont Hospital, Montreal, Canada
Principal Investigator: Andrea Velardi, MD University of Perugia, Italy
Principal Investigator: Katy Rezvani, MD PhD Hammersmith Hospital, London, United Kingdom
PRS Account Kiadis Pharma
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP