Haplo-Identical/Cord Blood Transplant for Leukemia

Overseen By Leland Metheny, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Inadequate organ function, Uncontrolled illness, Pregnant, Prior transplants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

36 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it allows for certain ongoing treatments like intrathecal chemotherapy or radiation therapy for specific conditions, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the treatment Haplo-Identical/Cord Blood Transplant for Leukemia?

Research shows that combining haploidentical stem cell transplants with umbilical cord blood can improve survival rates and reduce relapse in leukemia patients. This approach has been found to provide reliable and fast recovery of blood cells and has favorable long-term outcomes, making it a promising option for patients without standard donors. ^{1 2 3 4 5}

Is the Haplo-Identical/Cord Blood Transplant for Leukemia safe for humans?

Haplo-Identical/Cord Blood Transplant has been shown to be generally safe, with low rates of early non-relapse mortality and graft-vs-host disease (a condition where the donated cells attack the recipient's body). It also offers rapid recovery of blood cells and has comparable safety outcomes to other types of stem cell transplants. ^{1 4 6 7 8}

How does the Haplo-Identical/Cord Blood Transplant treatment for leukemia differ from other treatments?

This treatment combines stem cells from a partially matched family donor (haplo-identical) with umbilical cord blood, which can lead to faster recovery of blood cells and lower risk of graft-versus-host disease (a condition where the donor cells attack the recipient's body) compared to other transplant options. It is particularly beneficial for patients who do not have a fully matched donor, offering similar survival outcomes to traditional matched donor transplants. ^{1 4 5 7 9}

What is the purpose of this trial?

The purpose of this study is to see if see if adding the specific combination of donors can result in acceptable levels of survival without evidence of disease.

Research Team

Leland Metheny, MD

Principal Investigator

Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center

Eligibility Criteria

This trial is for patients with certain blood cancers or disorders, like different types of leukemia and myelodysplastic syndrome. Participants should be suitable candidates for a stem cell transplant but the specific eligibility criteria are not provided.

Inclusion Criteria

I have a specific type of blood cancer such as AML, ALL, or MDS.

I have a donor match for my transplant that meets the specific cell count requirements.

I am receiving treatment for leukemia or lymphoma outside the bone marrow or in the brain as needed.

Exclusion Criteria

My organs are not functioning well.

Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds

I had a stem cell transplant or CAR-T therapy in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation

Participants receive a co-transplant of an unmodified haplo-identical graft with cord blood, followed by post-transplant cyclophosphamide for aGVHD prophylaxis

Immediate post-transplant period

Engraftment

Monitoring for neutrophil and platelet engraftment post-transplant

60 days

Follow-up

Participants are monitored for progression free survival and overall survival

3 years

Treatment Details

Interventions

• Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood

Trial Overview The study is testing whether combining two types of donors – an unmodified haplo-identical donor and cord blood – can improve survival rates without disease in patients after a stem cell transplant.

Participant Groups

Group I: Haplo-Identical / Cord Blood Transplant Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

Haploidentical stem cell transplantation (haplo-SCT) is a viable option for high-risk leukemia patients without matched donors, showing comparable outcomes to other transplantation methods like matched sibling donor and umbilical cord blood transplants.

Innovative strategies, such as co-transplanting haploidentical allografts with cord blood, have demonstrated feasibility and potential to enhance treatment effectiveness by reducing relapse rates after haplo-SCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haploidentical stem cell transplantation for the treatment of leukemia: current status. Chang, YJ., Wang, Y., Huang, XJ.[2014]

References

1. England pubmed.ncbi.nlm.nih.gov

Haploidentical stem cell transplantation for the treatment of leukemia: current status. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Cord Haploidentical Non-In Vitro T Cell Depletion Allogeneic Hematopoietic Stem Cell Transplantation Reduces Relapse of Refractory Acute Leukemia. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Umbilical Cord Blood or HLA-Haploidentical Transplantation: Real-World Outcomes versus Randomized Trial Outcomes. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Alternative donor transplantation--"mixing and matching": the role of combined cord blood and haplo-identical donor transplantation (haplo-cord SCT) as a treatment strategy for patients lacking standard donors? [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of B Cell Acute Lymphoblastic Leukemia Patients Treated with Haploidentical Stem Cells Combined with Umbilical Cord Blood Transplantation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Hematopoietic stem cell transplantation from alternative sources in adults with high-risk acute leukemia. [2004]

7. United States pubmed.ncbi.nlm.nih.gov

Haploidentical vs haplo-cord transplant in adults under 60 years receiving fludarabine and melphalan conditioning. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Comparison of transplant outcomes between haploidentical transplantation and single cord blood transplantation in non-remission acute myeloid leukaemia: A nationwide retrospective study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Haploidentical Cord Blood Transplantation with 8 mg/kg Antithymocyte Globulin as Graft-versus-Host Disease Prophylaxis Compared to Haploidentical Transplantation with 10 mg/kg Antithymocyte Globulin in the Treatment of Acute Leukemia. [2023]