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Bone Marrow Transplant

Bone Marrow Transplant for Leukemia

Phase 1 & 2

Recruiting

Research Sponsored by Ossium Health, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status score ≥70% (MAC) or ≥60% (RIC)

Cardiac: LVEF at rest ≥45% (RIC) or LVEF at rest ≥40% (MAC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 100, day 180, and day 365

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of bone marrow transplants from deceased donors in patients with leukemia. Patients will be monitored for 56 days and followed-up for 1 year.

Who is the study for?

This trial is for adults aged 18-55 (or up to 70 for a specific regimen) with certain types of acute leukemia in remission, who need a bone marrow transplant and match the donor's tissue type at least half-way. They must be able to consent, have decent heart function and overall health status, and commit to study procedures for one year.Check my eligibility

What is being tested?

The study tests the safety of bone marrow transplants from deceased donors in patients with blood cancers. It compares two pre-transplant conditioning regimens: myeloablative (stronger) or reduced intensity (milder), followed by close monitoring for nearly two months post-transplant.See study design

What are the potential side effects?

Potential side effects include reactions related to chemotherapy drugs like Busulfan and Fludarabine such as nausea, fatigue, mouth sores; complications from radiation therapy; immune suppression risks from Tacrolimus and Mycophenolate Mofetil; infection risk due to low white cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly able to care for myself but may need help.

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My heart's pumping ability is within the required range.

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I am partially or fully matched for a bone marrow transplant.

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My lung function tests are at least half of what is expected for someone healthy.

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I have acute leukemia in remission with minimal bone marrow involvement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 100, day 180, and day 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 100, day 180, and day 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 100, day 180, and day 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CTCAE Grade 3/4 Adverse Events (AEs)

Death

Neutrophil Engraftment

+1 more

Secondary outcome measures

Cumulative incidence of disease relapses

Graft-vs-Host Disease

Cumulative incidences of chronic (cGVHD) Graft Versus Host Disease

+4 more

Other outcome measures

Length of Stay in Hospital

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment4 Interventions

*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 Post-Transplant treatment with Cyclophosphamide, Tacrolimus, Mycophenolate Mofetil, and Filgrastim

Group II: Cohort 1Experimental Treatment3 Interventions

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 Post-Transplant treatment with Cyclophosphamide, Tacrolimus, Mycophenolate Mofetil, and Filgrastim

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Center for International Blood and Marrow Transplant ResearchNETWORK

38 Previous Clinical Trials

200,193,418 Total Patients Enrolled

Ossium Health, Inc.Lead Sponsor

9 Previous Clinical Trials

136 Total Patients Enrolled

Jeffery Auletta, MDStudy ChairCenter for International Blood and Marrow Transplant Research

3 Previous Clinical Trials

223 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant count of this trial?

"Affirmative. Information hosted on clinicaltrials.gov demonstrates that this medical trial is actively recruiting participants as of 11/21/2023 - the date when it was last updated. 12 individuals, distributed between 2 research centres, are required for successful completion of the project."

Answered by AI

Does the protocol for this experiment extend to elderly individuals?

"This clinical trial is welcoming participants who have reached the age of majority and are younger than 70 years old."

Answered by AI

Who is eligible to take part in this research experiment?

"Twelve participants, ranging from 18 to 70 years of age and diagnosed with acute leukemia, are being enrolled in this trial. In order to be eligible for participation, these individuals must also meet the following prerequisites: willingly consenting to study protocols; having a Karnofsky performance status score of at least 70% (MAC) or 60% (RIC); possessing a Hematopoietic Cell Transplantation-Comorbidity Index lower than 5; displaying a left ventricular ejection fraction that is no less than 45% (RIC) or 40% (MAC); exhibiting pulmonary capacities such as DLCO, FE"

Answered by AI

Has this medical experiment opened up enrollment opportunities for patients?

"Yes, clinicaltrials.gov confirms that enrollment is currently in progress for this trial which was first announced on November 30th 2023 and had its latest update on the 21st of same month. It requires 12 participants to be sourced from 2 seperate sites."

Answered by AI

What are the major goals of this investigation?

"The primary outcome evaluated over Day 28 is the occurrence of Serious Adverse Events. Secondary outcomes include Cumulative incidences of chronic Graft Versus Host Disease (cGVHD) per National Institutes of Health consensus criteria, incidence rate for clinically significant infections requiring antimicrobial therapy and Cumulative incidences of neutrophil engraftment at an absolute count greater than 500/µL on three different days within a period of four weeks."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05589896.