Trials Sponsors Conditions Drugs Pricing

Conditions

Hematologic Diseases Hematologic Malignancies

Keywords

Haploidentical stem cell transplantationGraft-versus-host diseaseImmune reconstitutionAlloreactive T-cellsPhotodepletionTH9402Transplant related mortalityHematologic malignancy

Outcome Measures

Primary Outcomes (1)

Dose limiting toxicity, defined as acute graft-versus-host disease grade III or IV
Within 30 days after ATIR infusion

Secondary Outcomes (5)

Immune reconstitution
Until 60 months after ATIR infusion
Rate of disease relapse
Until 60 months after ATIR infusion
Occurrence and severity of graft-versus-host disease

Study Arms (7)

L1 (dose 1.0x10E4 T-cells/kg)

EXPERIMENTAL

Biological: Donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR)

L2 (dose 5.0x10E4 T-cells/kg)

EXPERIMENTAL

Biological: Donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR)

L3 (dose 1.3x10E5 T-cells/kg)

EXPERIMENTAL

Biological: Donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR)

Interventions

Donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR)Biological

Single intravenous infusion

L1 (dose 1.0x10E4 T-cells/kg)L2 (dose 5.0x10E4 T-cells/kg)L3 (dose 1.3x10E5 T-cells/kg)L4 (dose 3.2x10E5 T-cells/kg)L5 (dose 7.9x10E5 T-cells/kg)L6 (dose 2.0x10E6 T-cells/kg)L7 (dose 5.0x10E6 T-cells/kg)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Any of the following hematologic malignancies: very high risk leukemia, acute leukemia, chronic myeloid leukemia (CML), lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS)
Incompatibility at two to three loci (HLA-A, B and/or DR) or a single DR locus of the unshared haplotype between the donor and recipient

Sponsors & Collaborators

Kiadis Pharma
Industrylead

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Related Publications (1)

Roy DC, Lachance S, Cohen S, Delisle JS, Kiss T, Sauvageau G, Busque L, Ahmad I, Bernard L, Bambace N, Boumedine RS, Guertin MC, Rezvani K, Mielke S, Perreault C, Roy J. Allodepleted T-cell immunotherapy after haploidentical haematopoietic stem cell transplantation without severe acute graft-versus-host disease (GVHD) in the absence of GVHD prophylaxis. Br J Haematol. 2019 Sep;186(5):754-766. doi: 10.1111/bjh.15970. Epub 2019 May 28.
PMID: 31135970DERIVED

MeSH Terms

Conditions

Hematologic DiseasesHematologic NeoplasmsGraft vs Host Disease

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsImmune System Diseases

Study Officials

Denis-Claude Roy, MD
Maisonneuve-Rosemont Hospital, Montréal, Canada
PRINCIPAL INVESTIGATOR

Enrollment

19 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 9, 2009

First Posted

October 12, 2009

Study Start

January 2005

Date type not reported

This date has not been verified as actual or estimated.

Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (7)

L1 (dose 1.0x10E4 T-cells/kg)

L2 (dose 5.0x10E4 T-cells/kg)

L3 (dose 1.3x10E5 T-cells/kg)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

L4 (dose 3.2x10E5 T-cells/kg)

L5 (dose 7.9x10E5 T-cells/kg)

L6 (dose 2.0x10E6 T-cells/kg)

L7 (dose 5.0x10E6 T-cells/kg)

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (7)

L1 (dose 1.0x10E4 T-cells/kg)

L2 (dose 5.0x10E4 T-cells/kg)

L3 (dose 1.3x10E5 T-cells/kg)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

L4 (dose 3.2x10E5 T-cells/kg)

L5 (dose 7.9x10E5 T-cells/kg)

L6 (dose 2.0x10E6 T-cells/kg)

L7 (dose 5.0x10E6 T-cells/kg)

You may not qualify if:

Source record

Locations