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Clinical Trials/EUCTR2016-004672-21-NL
EUCTR2016-004672-21-NL
Active, not recruiting
Phase 1

A Phase III, multicenter, randomized controlled study to compare safety and efficacy of a haploidentical HSCT and adjunctive treatment with ATIR101, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells, versus a haploidentical HSCT with post-transplant cyclophosphamide in patients with a hematologic malignancy - HATCY study

Kiadis Pharma Netherlands BV0 sites250 target enrollmentJuly 19, 2017
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ConditionsPatients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCTMedDRA 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: 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: 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]

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 BV
Enrollment
250
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 19, 2017
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Any of the following hematologic malignancies:
  • •\- Acute myeloid leukemia (AML) in first cytomorphological remission (with \< 5%
  • •blasts in the bone marrow) with Disease Risk Index (DRI) intermediate or above, or
  • •in second or higher cytomorphological remission (with \< 5% blasts in the bone
  • •\- Acute lymphoblastic leukemia (ALL) in first or higher remission (with \< 5% blasts in
  • •the bone marrow)
  • •\- Myelodysplastic syndrome (MDS): transfusion\-dependent (requiring at least one
  • •transfusion per month), or intermediate or higher IPSS\-R risk group)
  • •2\. Clinical justification of allogeneic stem cell transplantation where a suitable HLA
  • •matched sibling or unrelated donor is unavailable in a timely manner.

Exclusion Criteria

  • •1\. Diagnosis of chronic myelomonocytic leukemia (CMML)
  • •2\. Availability of a suitable HLA\-matched sibling or unrelated donor in a donor search
  • •3\. Prior allogeneic hematopoietic stem cell transplantation
  • •4\. Diffusing capacity for carbon monoxide (hemoglobin corrected DLCO) \< 50% predicted
  • •5\. Left ventricular ejection fraction \< 45% (evaluated by echocardiogram or MUGA scan)
  • •6\. AST and/or ALT \> 2\.5 × ULN (CTCAE grade 2\)
  • •7\. Creatinine clearance \< 50 ml/min (calculated or measured)
  • •8\. Positive pregnancy test or breastfeeding of patient or donor (women of childbearing age
  • •9\. Estimated probability of surviving less than 3 months
  • •10\. Known allergy to any of the components of ATIR101 (e.g., dimethyl sulfoxide)

Outcomes

Primary Outcomes

Not specified

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A Phase III, multicenter, randomized controlled study to compare safety and efficacy of a haploidentical HSCT and adjunctive treatment with ATIR101, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells, versus a haploidentical HSCT with post-transplant cyclophosphamide in patients with a hematologic malignancy (HATCY studie)
NL-OMON48941Kiadis Pharma Netherlands B.V.4
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Safety and efficacy of ATIR101 as adjunctive treatment to blood stem cell transplantation from a haploidentical family donor compared to post-transplant cyclophosphamide in patients with blood cancerPatients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCTMedDRA version: 20.0Level: LLTClassification code 10059044Term: Allogeneic peripheral hematopoietic stem cell transplantSystem Organ Class: 100000022080MedDRA version: 20.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000012958MedDRA 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]
EUCTR2016-004672-21-ESKiadis Pharma Netherlands B.V.43
Active, not recruiting
Phase 1
Safety and efficacy of ATIR101 as adjunctive treatment to blood stem cell transplantation from a haploidentical family donor compared to post-transplant cyclophosphamide in patients with blood cancerPatients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCTMedDRA 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: LLTClassification code 10059044Term: Allogeneic peripheral hematopoietic stem cell transplantSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA 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]
EUCTR2016-004672-21-BEKiadis Pharma Netherlands B.V.195
Active, not recruiting
Phase 1
Safety and efficacy of ATIR101 as adjunctive treatment to blood stem cell transplantation from a haploidentical family donor compared to post-transplant cyclophosphamide in patients with blood cancerPatients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCTMedDRA version: 21.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 22.0Level: LLTClassification code 10059044Term: Allogeneic peripheral hematopoietic stem cell transplantSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: PTClassification code 10027703Term: Mismatched donor bone marrow transplantation therapySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: 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]
EUCTR2016-004672-21-PTKiadis Pharma Netherlands B.V.43
Active, not recruiting
Phase 1
Safety and efficacy of ATIR101 as adjunctive treatment to blood stem cell transplantation from a haploidentical family donor compared to post-transplant cyclophosphamide in patients with blood cancerPatients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCTMedDRA 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: LLTClassification code 10059044Term: Allogeneic peripheral hematopoietic stem cell transplantSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA 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]
EUCTR2016-004672-21-GBKiadis Pharma Netherlands B.V.250