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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

NCT02500550 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-05-18

Study results available
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Summary

The purpose of this study is to determine whether a repeat dose administration of ATIR101 is safe and effective when infused in patients with a hematologic malignancy following a T-cell depleted stem cell graft from a related haploidentical donor. All patients are planned to receive two ATIR101 doses of 2×10E6 viable T-cells/kg, unless the second dose is reduced or halted for safety reasons.

Conditions

Interventions

BIOLOGICAL

ATIR101

T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).

PROCEDURE

Haploidentical hematopoietic stem cell transplantation (HSCT)

CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended: * Total Body Irradiation (TBI) regime * Non-TBI regime (See below for details)

PROCEDURE

TBI regime

* Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions) * Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3 * Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7 * Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.

PROCEDURE

Non-TBI regime

* Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4 * Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7 * Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1 * ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.

Sponsors & Collaborators

  • Kiadis Pharma

    lead INDUSTRY

Principal Investigators

  • Denis Claude Roy, Prof MD · Maisonneuve-Rosemont Hospital (Montreal, Canada)

  • Stephan Mielke, Prof MD · Centre for Allogeneic Stem Cell Transplantation, Karolinska University Hospital (Stockholm, Sweden)

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-09
Primary Completion
2018-07-31
Completion
2018-12-17

Countries

  • Belgium
  • Canada
  • Croatia
  • Germany
  • Portugal
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02500550 on ClinicalTrials.gov