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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ossium HPC, Marrow

    Other intervention

    Cryopreserved deceased donor bone marrow

  • Standard of care living donor - Haplo Related

    Other intervention

    Haplo Related PBSC donor

  • Standard of care living donor - Mismatched Unrelated

    Other intervention

    Mismatched Unrelated PBSC donor

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Ossium HPC, Marrow DonorExperimental treatment 1 intervention
Group B: Haplo Related PBSC DonorOther 1 intervention
Group C: Mismatched unrelated PBSC DonorOther 1 intervention

Trial outcomes

Primary outcomes

1

To determine cumulative neutrophil engraftment

Characterize cumulative neutrophil engraftment in Ossium HPC, Marrow arm

Time frame
Day 30

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ossium Health, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: