Trial | NCT00993486  Report issue

Title

Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor
Phase I, Dose-ranging, Open-label, Study of a Single Administration of T-cells Add-back Depleted of Host Alloreactive Cells Using Theralux™ Therapy, Following Haploidentical Peripheral Blood Stem Cell Transplantation Submitted to CD34+ Cell Selection, in Patients With Severe Hematologic Malignancies

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    19
The purpose of this study is to determine the maximum tolerated dose and evaluate the safety of the administration of donor lymphocytes depleted of alloreactive T-cells following a stem cell transplant from a related, haploidentical donor, in patients with severe hematologic malignancies.
Allogeneic stem cell transplantation is the treatment of choice for many patients with leukemia and other hematologic malignancies. However, a major limitation of this therapy is that for a significant number of patients no fully HLA-matched donor can be found. The application of partially HLA-matched (haploidentical) family donors, who are virtually always available, has some complications. If there is no T-cell add-back it increases the risk for life-threatening infections and disease relapse, while in case of T-cell add-back the risk of graft-versus-host disease is raised.

Kiadis Pharma has developed a method to selectively deplete host alloreactive T-cells through photodynamic therapy, using TH9402 ex vivo. The donor lymphocyte preparation depleted of functional alloreactive T-cells (ATIR) are administered to the patient 4-6 weeks after the stem cell transplant. This method enables early immune reconstitution while preventing graft-versus-host disease.
Study Started
Jan 31
2005
Primary Completion
Oct 31
2008
Study Completion
Apr 30
2013
Last Update
Jun 20
2013
Estimate

Biological Donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR)

Single intravenous infusion

L1 (dose 1.0x10E4 T-cells/kg) Experimental

L2 (dose 5.0x10E4 T-cells/kg) Experimental

L3 (dose 1.3x10E5 T-cells/kg) Experimental

L4 (dose 3.2x10E5 T-cells/kg) Experimental

L5 (dose 7.9x10E5 T-cells/kg) Experimental

L6 (dose 2.0x10E6 T-cells/kg) Experimental

L7 (dose 5.0x10E6 T-cells/kg) Experimental

Criteria 

Inclusion Criteria:

Any of the following hematologic malignancies: very high risk leukemia, acute leukemia, chronic myeloid leukemia (CML), lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS)
Incompatibility at two to three loci (HLA-A, B and/or DR) or a single DR locus of the unshared haplotype between the donor and recipient
Life expectancy of at least 3 months
Satisfactory performance status (ECOG ≤ 2);

Exclusion Criteria:

Possibility of performing an allogeneic transplant with an HLA (human leukocyte antigen) matched sibling donor
Availability of an 6/6 HLA-A, B and DRB1 matched unrelated donor within 2-3 months;
Pregnancy
Viral hepatitis (B or C)
Active serious infectious process
HIV positivity;
Systemic dysfunction (cardiac, pulmonary, hepatic and renal) contra-indicating allogeneic stem cell transplantation
Prior allogeneic transplantation
Prior autologous transplantation within twelve months of baseline visit
Any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient condition or study outcome
Active central nervous system (CNS) disease at baseline
Participation in a trial with an investigational agent within 30 days prior to entry in the study
Malignant cells in circulating peripheral blood (> 25%)
Other active malignant disease that would severely limit life expectancy
No Results Posted