EUCTR2016-004672-21-ES
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
ConditionsPatients 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]
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
- 43
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Any of the following hematologic malignancies:
- •\- Acute myeloid leukemia (AML) in first cytomorphological remission with Disease Risk Index (DRI) intermediate or above, or in second or higher cytomorphological remission
- •\- Acute lymphoblastic leukemia (ALL) in first or higher remission
- •\- 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. An unrelated donor search is not required for a patient to be eligible if the clinical situation dictates an urgent transplantation. Clinical urgency is defined as 6\-8 weeks from referral to transplant center or low likelihood of finding a matched unrelated donor
- •3\. Availability of a related haploidentical donor with \= 4/8 but \< 8/8, or \= 5/10 but \< 10/10 matches at the HLA\-A, \-B, \-C, \-DRB1, and/or \-DQB1 loci, as determined by high resolution HLA\-typing
- •4\. Karnofsky Performance Status (KPS) \= 70%
- •5\. Male or female, age \= 18 years and \= 70 years
- •Patients aged \= 65 years must have a Sorror score \= 3
- •6\. Availability of a donor aged \= 16 years and \= 75 years who is eligible according to local requirements and regulations
Exclusion Criteria
- •1\. Availability of a suitable fully matched related or unrelated donor in a donor search
- •2\. Prior allogeneic hematopoietic stem cell transplantation
- •3\. Diffusing capacity for carbon monoxide (DLCO) \< 50% predicted
- •4\. Left ventricular ejection fraction \< 50% (evaluated by echocardiogram or MUGA)
- •5\. AST and/or ALT \> 2\.5 × ULN (CTCAE grade 2\)
- •6\. Bilirubin \> 1\.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 only)
- •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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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