Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06904482

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

Led by Case Comprehensive Cancer Center · Updated on 2026-02-27

36

Participants Needed

1

Research Sites

236 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with high-risk acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndromes (MDS), or high-risk lymphoma
  • AML participants in complete remission 1, 2, 3, or incomplete remission
  • ALL participants in high-risk complete remission 1 or beyond
  • MDS participants with intermediate, high, or very high risk by IPSS-R or treatment-related MDS
  • Age over 18 years
  • No suitable human leukocyte antigen (HLA)-matched related or unrelated donor available
  • Suitable grafts available: a 4-8/8 HLA matched cord blood unit with 1x10^5 CD34 cells/kg and a haplo-identical donor with at least 2x10^6 CD34 cells/kg
  • Ability to understand and willing to sign informed consent
  • Concurrent therapy allowed for extramedullary leukemia or CNS lymphoma with CNS remission at enrollment
  • Maintenance therapy after transplant is permitted
Not Eligible

You will not qualify if you...

  • Kidney function with creatinine clearance less than 40 ml/min
  • Liver function with bilirubin over twice the normal limit unless Gilbert syndrome
  • Liver enzymes AST or ALT more than 3 times the normal limit
  • Lung function with DLCOc less than 60%
  • Heart function with left ventricular ejection fraction less than 40%
  • Eastern Cooperative Oncology Group (ECOG) performance status less than 2
  • Uncontrolled illness including active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting study compliance
  • Pregnant or breastfeeding women
  • Any condition interfering with study participation or posing risk as judged by investigator
  • Known allergy or intolerance to study drugs or similar compounds
  • Prior autologous stem cell transplant or CAR-T therapy within 6 months or prior allogeneic transplant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

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Research Team

L

Leland Metheny, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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