Know Cancer

or
forgot password

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


Phase 2/Phase 3
18 Years
65 Years
Not Enrolling
Both
Myeloid Leukemia, Lymphoblastic Leukemia, Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome, Myeloproliferative Disorders

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Transplant related mortality

Outcome Time Frame:

6 and 12 months after the transplantation

Safety Issue:

No

Principal Investigator

Stephan Mielke, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Julius Maximilian University of Würzburg, Germany

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

CR-AIR-004

NCT ID:

NCT00967343

Start Date:

August 2009

Completion Date:

February 2012

Related Keywords:

  • Myeloid Leukemia
  • Lymphoblastic Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Myelodysplastic Syndrome
  • Myeloproliferative Disorders
  • Haploidentical stem cell transplantation
  • Graft-versus-host disease
  • Immune reconstitution
  • Alloreactive T-cells
  • Photodepletion
  • TH9402
  • Transplant related mortality
  • Hematologic malignancy
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders

Name

Location

Ohio State University, Comprehesive Cancer Center Columbus, Ohio  43210