NCT00967343 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2, PHASE3
Status at capture: TERMINATED
Registry last update: 2021-06-14

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 .

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Transplant Related Mortality

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outcome · POSTED

Incidence and Severity Graft-versus-host Disease (GVHD)

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outcome · POSTED

Progression Free Survival

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outcome · POSTED

Incidence and Severity of Bacterial, Viral or Fungal Infection

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outcome · POSTED

Immune Reconstitution

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outcome · POSTED

Health Status (Including Quality of Life)

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outcome · POSTED

Overall Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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.
healthy Volunteers: false
maximum Age: 65 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Biological: Donor lymphocyte preparation depleted of host functional alloreactive T-cells
label
ATIR
type
EXPERIMENTAL

interventions

arm Group Labels
ATIR
description
Single intravenous infusion with 2x10E6 T-cells/kg
name
Donor lymphocyte preparation depleted of host functional alloreactive T-cells
type
BIOLOGICAL

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

PREVENTION

Enrollment

count: 40
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
TRM is defined as death due to causes other than disease relapse or progression, or other causes which are unrelated to the transplantation procedure (e.g. accident, suicide)
measure
Transplant Related Mortality
time Frame
6, 12 and 24 months after the transplantation

secondary Outcomes

description
GVHD was graded according to standard criteria as referred to in the reference module (Filipovich et al. 2005; Przepiorka et al. 1995).
measure
Incidence and Severity Graft-versus-host Disease (GVHD)
time Frame
Up to 24 months after the transplantation
measure
Progression Free Survival
time Frame
Up to 24 months after the transplantation
measure
Incidence and Severity of Bacterial, Viral or Fungal Infection
time Frame
Up to 24 months after the transplantation
measure
Immune Reconstitution
time Frame
Up to 24 months after the transplantation
measure
Health Status (Including Quality of Life)
time Frame
Up to 24 months after the transplantation
measure
Overall Survival
time Frame
6, 12, and 24 months after the transplantation

Full study description

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.

Source references

references

citation
Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ, Martin P, Chien J, Przepiorka D, Couriel D, Cowen EW, Dinndorf P, Farrell A, Hartzman R, Henslee-Downey J, Jacobsohn D, McDonald G, Mittleman B, Rizzo JD, Robinson M, Schubert M, Schultz K, Shulman H, Turner M, Vogelsang G, Flowers ME. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56. doi: 10.1016/j.bbmt.2005.09.004.
pmid
16338616
type
BACKGROUND
citation
Przepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995 Jun;15(6):825-8.
pmid
7581076
type
BACKGROUND

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice