RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-16
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05589896

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient has the ability to provide informed consent according to the applicable regulatory and local institutional requirements
  2. * 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)
  3. * Patient must require allogeneic HCT per the discretion of the treating physician
  4. * 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
  5. * Stated willingness to comply with all study procedures and availability for the duration of the study
  6. * Diagnosed with malignant hematologic disease including:
  7. 1. Acute leukemia \[acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), acute biophenotypic leukemia (ABL), or acute undifferentiated leukemia (AUL)\], MDS without fibrosis, or chronic leukemia (CLL, CML) in the first remission or beyond with ≤5% marrow blasts documented by bone marrow assessment and no circulating blasts or extra-medullary disease within 42 days prior to anticipated start of conditioning
  8. 2. Chemosensitive non-Hodgkin's lymphomas, Hodgkin's lymphoma, or cutaneous T cell lymphomas in the first remission or beyond documented by PET/CT imaging and bone marrow assessment within 42 days prior to anticipated start of conditioning
  9. * Karnofsky performance status score ≥70% (MAC) or ≥60% (RIC)
  10. * HCT comorbidity index (HCT-CI) ≤5
  11. * Adequate organ function defined as:
  12. 1. Cardiac: LVEF at rest ≥40% (RIC) or LVEF at rest ≥45% (MAC)
  13. 2. Pulmonary: DLCO, FEV1, FVC ≥50% predicted by pulmonary function tests (PFTs). DLCO value may be corrected for hemoglobin.
  14. 3. Hepatic: total bilirubin ≤2.0 mg/dL, and ALT, AST, and ALP \<3 x upper limit normal (ULN), unless ALT, AST, and/or ALP are disease related
  15. 4. Renal: SCr within 1.5x normal range for age. If SCr is outside normal range for age, CrCl\> 60 mL/min/1.73m2 must be obtained (measured by 24-hour urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR)
  1. * 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)
  2. * Prior autologous or allogeneic HCT
  3. * Pregnancy or lactation
  4. * Ongoing treatment with an investigational drug used for disease-related treatment within 5 half-lives of the drug
  5. * Current uncontrolled bacterial, viral or fungal infection defined as currently taking medication with evidence of progression of clinical symptoms or radiologic findings
  6. * Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that in the investigator's opinion precludes participation

Contacts and Locations

Study Contact

Matthew Flores
CONTACT
(763)406-3060
PRESERVE@nmdp.org
Preethi Prasad, MSc.
CONTACT
preethi.prasad@ossiumhealth.com

Principal Investigator

Jeffery Auletta, MD
STUDY_CHAIR
Center for International Blood and Marrow Transplant Research

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Henry Ford Cancer Institute
Detroit, Michigan, 48202
United States
Columbia University - Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
TriStar Bone Marrow Transplant
Nashville, Tennessee, 37203
United States
St. David's South Austin Medical Center
Austin, Texas, 78745
United States
Methodist Hospital, Texas Transplant
San Antonio, Texas, 78229
United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Ossium Health, Inc.

  • Jeffery Auletta, MD, STUDY_CHAIR, Center for International Blood and Marrow Transplant Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-16
Study Completion Date2027-11

Study Record Updates

Study Start Date2024-08-16
Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

  • Leukemia
  • Hematologic Diseases
  • ALL
  • AML
  • ABL
  • AUL
  • Bone Marrow Transplant
  • Lymphoma
  • MDS
  • CLL
  • CML

Additional Relevant MeSH Terms

  • Acute Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Acute Biphenotypic Leukemia
  • Acute Undifferentiated Leukemia
  • CLL (Chronic Lymphocytic Leukemia)
  • Chronic Myeloid Leukemia (CML)
  • MDS (Myelodysplastic Syndrome)
  • Non-Hodgkin Lymphomas
  • Hodgkins Lymphoma
  • Cutaneous T Cell Lymphomas (CTCL)