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A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies

ConditionsAcute LeukemiaAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAcute Biphenotypic LeukemiaAcute Undifferentiated LeukemiaCLL (Chronic Lymphocytic Leukemia)Chronic Myeloid Leukemia (CML)MDS (Myelodysplastic Syndrome)Non-Hodgkin LymphomasHodgkins LymphomaCutaneous T Cell Lymphomas (CTCL)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOssium Health, Inc.

About this trial

The goal of this clinical trial is to determine the safety and feasibility of allogeneic transplantation with bone marrow from a deceased donor in patients with acute and chronic leukemias, myelodysplastic syndrome, and certain lymphomas. Patients will either receive myeloablative conditioning or reduced intensity conditioning regimen prior to the transplant. Patients will be followed for 56 days for safety endpoints and remain in follow-up for one year.

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 ≥18 and ≤65 years for patients receiving MAC (Regimen A or Regimen B); aged ≥18 and ≤75 years for patients receiving RIC (Regimen C or D)

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

Patient must be high-resolution, HLA partially or fully matched (4-8/8 allele matched at HLA-A, -B, -C, DRB1) to an available Ossium HPC, Marrow product

Disqualifiers

Availability of suitable graft from living donor (defined as 7/8 or 8/8 HLA-matched related or unrelated donors, haploidentical donors, or cord blood donors)

Prior autologous or allogeneic HCT

Pregnancy or lactation

Ongoing treatment with an investigational drug used for disease-related treatment within 5 half-lives of the drug

Trial design

Design model

Sequential

Treatments tested in this trial

  • Ossium HPC Marrow, Bone Marrow Transplant

    Other intervention

    Hematopoetic Cell Transplantation

  • Pre-transplant conditioning - Myeloablative (MAC)

    Other intervention

    Regimen A or Regimen B

  • Pre-transplant conditioning - Reduced Intensity (RIC)

    Other intervention

    Regimen C or Regimen D

  • Post-transplant treatment

    Other intervention

    Post-transplant treatment

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Cohort 1Experimental treatment 4 interventions
Group B: Cohort 2Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Neutrophil Engraftment

Neutrophil engraftment is defined as achieving an absolute neutrophil count (ANC) of greater than or equal to 500/µL for 3 consecutive measurements on 3 different days by Day 28.

Time frame
Day 28
2

Serious Adverse Events

Occurrence of any event classified as SAE. The time of occurrence of each serious adverse event will be recorded.

Time frame
Day 56
3

CTCAE Grade 3/4 Adverse Events (AEs)

Occurrence of any event classified as grade 3/4 AE attributed to Ossium HPC, Marrow per the CTCAE v5.0 guidelines. The time of the occurrence of each event will be recorded.

Time frame
Day 56
4

CTCAE Grade 3/4 Adverse Events (AEs) attributed to infusion of Ossium HPC, Marrow

Occurrence of any event classified as grade 3 or higher attributed to Ossium HPC, Marrow infusion per the CTCAE v5.0 guidelines. The time of the occurrence will be recorded.

Time frame
Day 28

Secondary outcomes

1

Cumulative incidences of neutrophil engraftment

Neutrophil engraftment in defined as achieving an absolute neutrophil count (ANC) of greater than or equal to 500/µL for 3 consecutive measurements on different days by Day 28.

Time frame
Day 28
2

Cumulative incidences of platelet recovery

Platelet recovery is defined as platelets greater than or equal to 20,000/µL for 3 consecutive days in the absence of transfusion for 7 consecutive days by Day 56.

Time frame
Day 56
3

Cumulative incidence of disease relapses

The cumulative incidence of relapse is measured from the date of transplant (Day 0) until the date of relapse or progression; patients not known to have relapsed are censored on the date they were last examined; patients who died without relapse are counted as a competing cause of failure.

Time frame
Day 365
4

Transplant-related mortality (TRM)

TRM is defined as death without evidence of disease progression or recurrence.

Time frame
Day 100 and Day 365

Other outcomes

1

Length of Stay in Hospital

Cumulative days alive and out of the hospital in the first 100 days and in the first year post-transplant.

Time frame
Day 100 and Day 365
2

Time to provide Ossium product to the patient from product availability request

Time from preliminary search to find a donor match in the Ossium registry and the time to provide Ossium HPC, Marrow product to recipient (time from donor availability request to delivery of product to transplant center).

Time frame
Day 365

Sponsors and contacts

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

Ossium Health, Inc.

Lead sponsor

Source ClinicalTrials.gov
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