Clinical Trial 22461

• Overview

  Study Title:

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

  Summary:

  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 leukemias. 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.

  Objective:

  Primary Objectives: 1. To determine neutrophil engraftment by Day 28 2. To determine primary safety in using Ossium HPC, Marrow as defined as the absence of CTCAE grade 3 or higher adverse events (AEs) attributed to Ossium HPC, Marrow and primary graft failure by Day 28 3. To determine serious adverse events (SAEs), CTCAE Grade 3/4 AEs, and death attributed to and within 56 days after infusion of Ossium HPC, Marrow Secondary Objectives: 1. To determine cumulative incidences of neutrophil engraftment (ANC ≥500/μL for 3 consecutive days) on Day 28 and platelet recovery (platelets ≥20,000/μL for 3 consecutive days in absence of transfusion for 7 days consecutive days) by Day 56 2. To determine cumulative incidences of acute and chronic graft versus host disease (aGVHD and cGVHD, respectively), transplant related mortality (TRM), and disease relapse 3. To determine incidence of clinically significant infections

• Treatments

  Therapies:

  Cell Therapy

  Medications:

  Ossium HPC (); busulfan (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

• Inclusion Criteria

  • Patient has the ability to provide informed consent according to the applicable regulatory and local institutional requirements
  • Male or female, aged >18 and 18 and > 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
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Diagnosed with acute leukemia [acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), acute biophenotypic leukemia (ABL), or acute undifferentiated leukemia (AUL)] in the first remission or beyond with ≤5% marrow blasts and no circulating blasts or extra-medullary disease documented by bone marrow assessment within 42 days prior to anticipated start of conditioning
  • Karnofsky performance status score >70% (MAC) or >60% (RIC)
  • HCT comorbidity index (HCT-CI) > Adequate organ function defined per protocol

• Exclusion Criteria

  • 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
  • Current uncontrolled bacterial, viral or fungal infection defined as currently taking medication with evidence of progression of clinical symptoms or radiologic findings
  • Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that in the investigator's opinion precludes participation

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.