Health Trials

Study to Characterize Mismatched to Fully HLA-Matched Ossium HPC, Marrow and Living Donor Transplantation in Patients With Hematologic Malignancies

ConditionsHematologic MalignancyAcute LeukemiaAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAcute Biphenotypic LeukemiaAcute Undifferentiated LeukemiaCLL (Chronic Lymphocytic Leukemia)Chronic Myeloid LeukemiaMDS (Myelodysplastic Syndrome)Non Hodgkin LymphomaHodgkin LymphomaCutaneous T Cell Lymphomas (CTCL)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-75
SponsorOssium Health, Inc.

About this trial

Prospective, multi-center open label study of HLA-partially to fully matched allogeneic cryopreserved deceased donor bone marrow transplantation and living donor transplantation for patients with hematologic malignancies.

Eligibility criteria

Qualifiers

Patient has the ability to provide informed consent according to the applicable regulatory and local institutional requirements.

Male or female, aged ≥12 and ≤65 years for patients receiving MAC aged ≥12 and ≤75 years for patients receiving RIC. Patients between 75 and 80 years on RIC regimen can be enrolled with prior sponsor approval

Patient must require first allogeneic HCT per the discretion of the treating physician

BMI <=50 (BMI of 45.1 to 50 maybe allowed after sponsor approval)

Disqualifiers

Autologous transplant within 6 months

Prior allogeneic HCT

Myeloproliferative disorders or MDS with grade 3 and higher fibrosis are excluded

HTLV-ATLL positive patients are excluded

Trial design

Treatments tested in this trial

  • Ossium HPC, Marrow
  • Standard of care living donor - Haplo Related
  • Standard of care living donor - Mismatched Unrelated

Treatment groups

300 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Ossium Health, Inc.

Lead sponsor

Source ClinicalTrials.gov