Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Bone Marrow Transplant with Ossium HPC, Marrow Pre-transplant myeloablative conditioning treatment with: Regimen A(MAC): Busulfan and Fludarabine [OR] Regimen B(MAC): Fludarabine and Total Body Irradiation [OR] Regimen C(RIC): Fludarabine, Cyclophosphamide, and Total Body Irradiation [OR] Regimen D (RIC): Fludarabine, Melphalan, and Total Body Irradiation Post-Transplant treatment with Cyclophosphamide, Tacrolimus, Mycophenolate Mofetil, and Filgrastim |
|
| Cohort 2 | Experimental | *Open to enrollment after DSMB review of Cohort 1 safety events through Day 56* Bone Marrow Transplant with Ossium HPC, Marrow Pre-transplant conditioning treatment with: Regimen A(MAC): Busulfan and Fludarabine [OR] Regimen B(MAC): Fludarabine and Total Body Irradiation [OR] Regimen C(RIC): Fludarabine, Cyclophosphamide, and Total Body Irradiation [OR] Regimen D(RIC): Fludarabine, Melphalan, and Total Body Irradiation Post-Transplant treatment with Cyclophosphamide, Tacrolimus, Mycophenolate Mofetil, and Filgrastim |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ossium HPC Marrow, Bone Marrow Transplant | Other | Hematopoetic Cell Transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 |
| Serious Adverse Events | Occurrence of any event classified as SAE. The time of occurrence of each serious adverse event will be recorded. | Day 56 |
| 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. | Day 56 |
| 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. | Day 28 |
| Death | The time of death will be recorded for each expired patient. | Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 |
| Cumulative incidences of platelet recovery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 100 and Day 365 |
| Time to provide Ossium product to the patient from product availability request |
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 ≤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
Stated willingness to comply with all study procedures and availability for the duration of the study
Diagnosed with malignant hematologic disease including:
Karnofsky performance status score ≥70% (MAC) or ≥60% (RIC)
HCT comorbidity index (HCT-CI) ≤5
Adequate organ function defined as:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Preethi Prasad, M.Sc. | Contact | 628-842-6562 | preethi.prasad@ossiumhealth.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
All patients will receive Ossium HPC, Marrow product. Study arms will be based on order of enrollment and planned conditioning regimen.
Not provided
Not provided
Not provided
Not provided
| Pre-transplant conditioning - Myeloablative (MAC) | Other | Regimen A or Regimen B |
|
|
| Pre-transplant conditioning - Reduced Intensity (RIC) | Other | Regimen C or Regimen D |
|
|
| Post-transplant treatment | Other | Post-transplant treatment |
|
|
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. |
| Day 56 |
| 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. | Day 365 |
| Transplant-related mortality (TRM) | TRM is defined as death without evidence of disease progression or recurrence. | Day 100 and Day 365 |
| Cumulative incidences of acute (aGVHD) Graft Versus Host Disease | aGVHD is defined as any skin, gastrointestinal or liver abnormalities fulfilling the criteria of grades II-IV or grades III-IV. | Day 100, Day 180, and Day 365 |
| Cumulative incidences of chronic (cGVHD) Graft Versus Host Disease | cGVHD is defined per National Institutes of Health (NIH) Consensus Criteria and includes organ involvement and severity, and overall global composite score (mild/moderate/severe). | Day 100, Day 180, and Day 365 |
| Incidence of clinically-significant infections | A clinically significant infection is defined as any microbiologic or radiographic infection for which antimicrobial therapy was administered. | Day 100 and Day 365 |
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).
| Day 365 |
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
|
| Emory University - Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| Henry Ford Cancer Institute | Recruiting | Detroit | Michigan | 48202 | United States |
|
| Oregon Health and Science University | Recruiting | Portland | Oregon | 97239 | United States |
|
| TriStar Bone Marrow Transplant | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| St. David's South Austin Medical Center | Recruiting | Austin | Texas | 78745 | United States |
|
| Methodist Hospital, Texas Transplant | Recruiting | San Antonio | Texas | 78229 | United States |
|
| University of Utah - Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D015456 | Leukemia, Biphenotypic, Acute |
| D015448 | Leukemia, B-Cell |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D006689 | Hodgkin Disease |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
Not provided
Not provided
| ID | Term |
|---|---|
| D016026 | Bone Marrow Transplantation |
| C042382 | fludarabine phosphate |
| D003520 | Cyclophosphamide |
| D015080 | Mesna |
| D008558 | Melphalan |
| D009173 | Mycophenolic Acid |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided