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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with certain blood cancers, such as acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL). The goal is to determine if combining two types of donor cells—haplo-identical (half-matched) relatives and cord blood—can improve survival without cancer recurrence. This approach, known as a co-transplant of an unmodified haplo-identical graft with cord blood, targets those without a perfect donor match who are in a specific stage of remission. Suitable participants may have faced issues like minimal disease after several chemotherapy cycles or not achieving complete remission promptly. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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 prior data suggests that this co-transplant of an unmodified haplo-identical graft with cord blood is safe?

Research has shown that combining a partially matched donor with an umbilical cord blood transplant is generally safe and well-tolerated. Studies indicate that this treatment can improve survival rates in patients with leukemia while minimizing side effects. One study found that using both partially matched transplants and umbilical cord blood helps blood cells recover faster, indicating safety.

This treatment is effective for patients without access to young, healthy donors. Although all treatments carry risks, this combination appears to be a promising option with manageable side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for leukemia?

Unlike the standard leukemia treatments that often involve chemotherapy and a single type of stem cell transplant, the Haplo-Identical/Cord Blood Transplant combines two sources of stem cells — a haplo-identical graft and umbilical cord blood. This dual-source approach may provide a more robust immune system replacement, which could enhance recovery and reduce complications. Researchers are excited because this method might offer a treatment option for patients who don't have a perfectly matched donor, potentially increasing transplant success rates and offering hope to more individuals battling leukemia.

What evidence suggests that this co-transplant of an unmodified haplo-identical graft with cord blood might be an effective treatment for leukemia?

Research has shown that using a mix of partially matched family donor transplants and cord blood transplants can effectively treat leukemia. This trial will evaluate the co-transplant of an unmodified haplo-identical graft with cord blood. Studies have found that this method can improve survival rates in patients with acute myeloid leukemia (AML) without causing excessive side effects. For example, one study found that patients who received this type of transplant had a better chance of being disease-free after one year compared to other methods. Another study reported a 92% overall survival rate in patients who had partially matched family donor transplants. This combined approach might offer more benefits than using just one type of transplant. ^{1 4 6 7 8}

Who Is on the Research Team?

Leland Metheny, MD

Principal Investigator

Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36281887/

Comparison of transplant outcomes between ... Our data showed comparable outcomes between haplo-HSCT and CBT recipients with non-remission AML.

2. nature.com nature.com/articles/s41392-024-01820-5

Haploidentical hematopoietic cell transplantation with or ... Haplo-cord HCT can improve OS in AML patients without excessive AEs, which may exert additional benefits for recipients of haplo-HCT.

3. astctjournal.org astctjournal.org/article/S2666-6367(24)00544-X/fulltext

Haploidentical versus Cord Blood Transplantation in ... In the Haplo-SCT group, there were 53 cases, whereas the CBT group had 23 cases. The outcomes observed were as follows: OS was 92% for Haplo-SCT ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2152265024024042

Comparison of Long-Term Outcomes of Double Unit Cord ... Cord blood transplantation was associated with higher non-relapse mortality rate compared to haploidentical transplantation, especially in older patients. •.

5. thelancet.com thelancet.com/journals/lanhae/article/PIIS2352-3026(24)00372-7/abstract

Haploidentical peripheral blood stem cells combined with ... Transplantation of haploidentical PBSCs plus unrelated cord blood achieved superior 1-year disease-free survival compared with transplantation ...

6. astctjournal.org astctjournal.org/article/S2666-6367(25)01408-3/fulltext

Efficacy and Safety of Haploidentical Hematopoietic Stem ... Haplo-HSCT combined with UCB infusion is a safe and effective strategy for patients lacking young donors, offering rapid hematopoietic recovery, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9820258/

In 2022, which is preferred: haploidentical or cord transplant? This article discusses the 2 options based on the currently available data, focusing on adults, and tries to give some clues to help the transplant physician ...

8. ashpublications.org ashpublications.org/blood/article/137/3/420/463595/Double-unrelated-umbilical-cord-blood-vs-HLA

Double unrelated umbilical cord blood vs HLA-haploidentical ... There is no significant difference in PFS between UCB and haploidentical transplantation for leukemia or lymphoma. Lower nonrelapse mortality ...