Efficacy and Safety of a Donor Lymphocyte Preparation Depleted of Functional Host Alloreactive T-cells (ATIR) in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor

NCT00967343 | Terminated Phase 2 Results DMC

• 2 other identifiers: CR-AIR-004EudraCT no. 2008-008198-73
• Study Type: interventional
• Target: 40
• Locations: 7 countries
• Sites: 15

Brief Summary

The purpose of this study is to determine whether the administration of a donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR) after a T-cell depleted stem cell transplant from a related, haploidentical donor enhances survival by improving the immune effect against infections while preventing graft-versus-host disease .

Conditions

Myeloid Leukemia; Lymphoblastic Leukemia; Lymphoma; Multiple Myeloma; Myelodysplastic Syndrome; Myeloproliferative Disorders

Keywords

Haploidentical stem cell transplantation; Graft-versus-host disease; Immune reconstitution; Alloreactive T-cells; Photodepletion; TH9402; Transplant related mortality; Hematologic malignancy

Outcome Measures

Primary Outcomes (1)

• Transplant Related Mortality

  TRM is defined as death due to causes other than disease relapse or progression, or other causes which are unrelated to the transplantation procedure (e.g. accident, suicide)

  6, 12 and 24 months after the transplantation

Secondary Outcomes (6)

• Incidence and Severity Graft-versus-host Disease (GVHD)

  Up to 24 months after the transplantation

• Progression Free Survival

  Up to 24 months after the transplantation

• Incidence and Severity of Bacterial, Viral or Fungal Infection

  Up to 24 months after the transplantation

• Immune Reconstitution

  Up to 24 months after the transplantation

• Health Status (Including Quality of Life)

  Up to 24 months after the transplantation

Study Arms (1)

ATIR

EXPERIMENTAL

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

Interventions

Donor lymphocyte preparation depleted of host functional alloreactive T-cells BIOLOGICAL

Single intravenous infusion with 2x10E6 T-cells/kg

ATIR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One of the following hematological malignancies:
• Acute Myeloid Leukemia (AML)
• Acute Lymphoblastic Leukemia (ALL)
• Myelodysplastic Syndrome (MDS)
• Ph-positive chronic myeloid leukemia (CML)
• Non-Hodgkin Lymphoma (NHL)
• Myelodysplastic Syndrome (MDS)
• Chronic Myeloid Leukemia (CML)
• Multiple Myeloma (MM)
• Chronic Lymphocytic Leukemia (CLL)
• Myeloproliferative Syndrome (MPS)

You may not qualify if:

• AML in 1st complete remission with good risk karyotypes
• MM featuring concurrent extramedullar disease or being non-responsive to prior therapy
• CML in blast crisis
• CLL concurrently transformed into high-grade lymphoma and failing to demonstrate at least partial remission
• NHL with concurrent bulky disease (≥ 5 cm)
• Diffusing Capacity for Carbon Monoxide (DLCO) \< 40% predicted
• Left ventricular ejection fraction \< 40%
• AST/SGOT \> 2.5 x ULN
• Bilirubin \> 1.5 x ULN
• Creatinine \> 1.5 x ULN
• HIV positive
• Positive pregnancy test for women of childbearing age
• Prior haploidentical peripheral blood stem cell or cord blood transplantation
• Less than 2 years from a prior allogeneic stem cell transplantation
• Estimated probability of surviving less than three months

Sponsors & Collaborators

• Kiadis Pharma: lead

Study Sites (15)

Ohio State University, Comprehesive Cancer Center

Columbus, Ohio, 43210, United States

Location

Algemeen Ziekenhuis Sint-Jan

Bruges, 8000, Belgium

Location

Université Libre de Bruxelles - Institute Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Gasthuisberg

Leuven, 3000, Belgium

Location

University of Liege - CHU Sart Tilman

Liège, 4000, Belgium

Location

HHSC, Henderson Hospital Site

Hamilton, Ontario, L8V 1C3, Canada

Location

Ontario Cancer Institute / Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Universitätsklinikum Freiburg, Medizinische UNI-Klinik

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikums Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

Universitätsklinikum Mainz

Mainz, 55101, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Perugia University

Perugia, 06123, Italy

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6229 HX, Netherlands

Location

Hammersmith Hospital

London, W12 ONN, United Kingdom

Location

Related Publications (2)

• Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ, Martin P, Chien J, Przepiorka D, Couriel D, Cowen EW, Dinndorf P, Farrell A, Hartzman R, Henslee-Downey J, Jacobsohn D, McDonald G, Mittleman B, Rizzo JD, Robinson M, Schubert M, Schultz K, Shulman H, Turner M, Vogelsang G, Flowers ME. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56. doi: 10.1016/j.bbmt.2005.09.004.

  PMID: 16338616 BACKGROUND

• Przepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995 Jun;15(6):825-8.

  PMID: 7581076 BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma; Multiple Myeloma; Myelodysplastic Syndromes; Myeloproliferative Disorders; Graft vs Host Disease; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Bone Marrow Diseases; Neoplasms by Site

Results Point of Contact

• Title: Andrew Sandler, MD / Chief Medical Officer
• Organization: Kiadis Pharma Netherlands B.V.

a.sandler@Kiadis.com

+1 206 779 9213

Study Officials

• Stephan Mielke, MD

  Julius Maximilian University of Würzburg, Germany

  STUDY CHAIR

• Denis-Claude Roy, MD

  Maisonneuve-Rosemont Hospital, Montreal, Canada

  STUDY CHAIR

• Andrea Velardi, MD

  University Of Perugia

  PRINCIPAL INVESTIGATOR

• Katy Rezvani, MD PhD

  Hammersmith Hospital, London, United Kingdom

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: August 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: June 14, 2021
• Results First Posted: January 12, 2021

Record last verified: 2021-05

Locations

CA (3); DE (4); US (1); IT (1); GB (1); NL (1); BE (4)