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 Cancer

PHASE3TerminatedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

November 29, 2017

Primary Completion Date

November 9, 2021

Study Completion Date

December 17, 2021

Conditions
Acute Myeloid LeukemiaAcute Lymphoblastic LeukemiaMyelodysplastic Syndrome
Interventions
BIOLOGICAL

ATIR101

ATIR101 is a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells using photodynamic treatment; single dose of 2×10E6 viable T-cells/kg body weight between 28 and 32 days after the HSCT (intravenous infusion)

DRUG

Cyclophosphamide

High dose post-transplant cyclophosphamide 50 mg/kg/day at 3 and 4/5 days after the HSCT (powder for intravenous infusion)

PROCEDURE

T-cell depleted HSCT from a related, haploidentical donor

T-cell depleted graft prepared from peripheral blood stem cells using the CD34+ cell selection method; infused after a total body irradiation (TBI) or non-TBI conditioning regimen

PROCEDURE

T-cell replete HSCT from a related, haploidentical donor

T-cell replete (full, non-manipulated) graft prepared from either bone marrow or peripheral blood stem cells; infused after a total body irradiation (TBI) or non-TBI conditioning regimen

Trial Locations (42)

1000

Institut Jules Bordet, Brussels

2650

Universitair Ziekenhuis Antwerpen, Antwerp

3000

Universitair Ziekenhuis Gasthuisberg, Leuven

4000

Centre Hospitalier Universitaire de Liège, Liège

8000

Algemeen Ziekenhuis Sint-Jan, Bruges

10000

University Hospital Centre Zagreb, Zagreb

10021

Weill Cornell Medical College, New York

10032

Columbia University Medical Center, New York

11794

Stony Brook University Hospital, Stony Brook

20122

Milano Hospital, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

28220

Hospital Puerta de Hierro Majadahonda, Madrid

30322

Emory University, Atlanta

41013

UGC Hematología y Hemoterapia, Seville

46026

Servicio de Hematología Hospital, Universitari I politècnic La Fe, Valencia

55131

University Medical Center Mainz, Mainz

66205

University of Kansas Cancer Center, Westwood

75475

APHP Hospital Saint Louis, Paris

81377

Ludwig-Maximilians-University Hospital of Munich-Grosshadern, Munich

90095

UCLA Center for Health Sciences, Los Angeles

91010

City of Hope National Medical Center, Duarte

91120

Hadassah Medical Center & Hadassah Hospital Ein Karem, Jerusalem

94305

Stanford University School of Medicine, Stanford

97080

Universitätsklinikum Würzburg, Würzburg

97239

Oregon Health & Science University, Portland

3109601

Rambam Medical Center, Haifa

5265601

Chaim Sheba Medical Center, Tel Litwinsky

6423906

Sourasky Medical Center & Tel Aviv University, Tel Aviv

92037-0698

Moores UC San Diego Cancer Center, La Jolla

02114

Massachusetts General Hospital, Boston

48109-1274

University of Michigan, Ann Arbor

H1T 2M4

Maisonneuve-Rosemont Hospital, Montreal

Unknown

University Hospital Frankfurt, Goethe University, Frankfurt

6229 HX

Academisch Ziekenhuis Maastricht, Maastricht

1649-028

Faculdade de Medicina da Universidade de Lisboa, Lisbon

08035

University Hospital Barcelona Vall d' Hebron, Barcelona

SE-141 86

Karolinska University Hospital, Stockholm

B9 5SS

Heartlands Hospital, Birmingham

LS9 7TF

St James University Hospital, Leeds

L7 8XP

Royal Liverpool University Hospital, Liverpool

W12 0HS

Hammersmith Hospital, London

M13 9WL

Manchester Royal Infirmary, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Kiadis Pharma

INDUSTRY

NCT02999854 - 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 Cancer | Biotech Hunter | Biotech Hunter