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Clinical Trials/EUCTR2015-002821-20-HR
EUCTR2015-002821-20-HR
Active, not recruiting
Phase 1

An exploratory, open-label, multicenter study to evaluate the safety and efficacy of a two-dose regimen of ATIR101, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment), in patients with a hematologic malignancy, who received a CD34-selected hematopoietic stem cell transplantation from a haploidentical donor

Kiadis Pharma Netherlands B.V.0 sites20 target enrollmentDecember 15, 2016
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ConditionsPatients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCTMedDRA version: 19.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: LLT Classification code 10059044 Term: Allogeneic peripheral hematopoietic stem cell transplant System Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 19.0 Level: PT Classification code 10027703 Term: Mismatched donor bone marrow transplantation therapy System Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 19.0 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCT
Sponsor
Kiadis Pharma Netherlands B.V.
Enrollment
20
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 15, 2016
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Any of the following hematologic malignancies:
  • •\- Acute myeloid leukemia (AML) in first remission with high\-risk features or in second or higher remission
  • •\- Acute lymphoblastic leukemia (ALL) in first remission with high\-risk features or in second or higher remission
  • •\- Myelodysplastic syndrome (MDS): transfusion\-dependent, or intermediate or higher IPSS\-R risk group
  • •Karnofsky performance status \= 70%
  • •Eligible for haploidentical stem cell transplantation according to the investigator
  • •Male or female, age \= 18 years and \= 65 years
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •Availability of a fully matched related or unrelated donor following a donor search
  • •Diffusing capacity for carbon monoxide (DLCO) \< 50% predicted
  • •Left ventricular ejection fraction \< 50% (evaluated by echocardiogram or MUGA)
  • •AST \> 2\.5 x ULN (CTCAE grade 2\)
  • •Bilirubin \> 1\.5 x ULN (CTCAE grade 2\)
  • •Creatinine clearance \< 50 mL/min (calculated or measured)
  • •Positive HIV test
  • •Positive pregnancy test (women of childbearing age only)
  • •Prior allogeneic HSCT
  • •Estimated probability of surviving less than 3 months

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Safety and efficacy of donor T-lymphocytes depleted ex vivo of host alloreactive T-cells (ATIR) in patients with a hematologic malignancy who received a hematopoietic stem cell transplantation from a haploidentical donor
EUCTR2012-004461-41-GBKiadis Pharma Netherlands B.V.30
Active, not recruiting
Phase 1
Safety and efficacy of two doses of ATIR101, a T-lymphocyte enriched leukocyte preparation depleted of host alloreactive T-cells, in patients with a hematologic malignancy who received a hematopoietic stem cell transplantation from a haploidentical donorPatients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCTMedDRA version: 20.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10059044 Term: Allogeneic peripheral hematopoietic stem cell transplant System Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0 Level: PT Classification code 10027703 Term: Mismatched donor bone marrow transplantation therapy System Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
EUCTR2015-002821-20-BEKiadis Pharma Netherlands B.V.20
Active, not recruiting
Phase 1
Safety and efficacy of donor T-lymphocytes depleted ex vivo of host alloreactive T-cells (ATIR) in patients with a hematologic malignancy who received a hematopoietic stem cell transplantation from a haploidentical donorPatients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCTMedDRA version: 19.1Level: LLTClassification code 10059044Term: Allogeneic peripheral hematopoietic stem cell transplantSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10027703Term: Mismatched donor bone marrow transplantation therapySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
EUCTR2012-004461-41-DEKiadis Pharma Netherlands B.V.30
Active, not recruiting
Phase 1
Safety and efficacy of two doses of ATIR101, a T-lymphocyte enriched leukocyte preparation depleted of host alloreactive T-cells, in patients with a hematologic malignancy who received a hematopoietic stem cell transplantation from a haploidentical donor
EUCTR2015-002821-20-DEKiadis Pharma Netherlands B.V.20
Active, not recruiting
Phase 1
Safety and efficacy of donor T-lymphocytes depleted ex vivo of host alloreactive T-cells (ATIR) in patients with a hematologic malignancy who received a hematopoietic stem cell transplantation from a haploidentical donorPatients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCTMedDRA version: 17.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: LLTClassification code 10059044Term: Allogeneic peripheral hematopoietic stem cell transplantSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 17.0Level: PTClassification code 10027703Term: Mismatched donor bone marrow transplantation therapySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 17.0Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
EUCTR2012-004461-41-BEKiadis Pharma Netherlands B.V.30