RECRUITING

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

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Conditions

aGVHDAcute Myelogenous LeukemiaAcute Lymphocytic LeukemiaMyelodysplastic SyndromesUnmodified Haplo-Identical Graft with Cord Bloodpost-transplant cyclophosphamide aGVHD prophylaxis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-29
Study Completion:2030-02-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06904482

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants with the following hematologic malignancies:
  2. * Acute myelogenous leukemia (AML): High-risk AML including:
  3. * Antecedent hematological disease (e.g., myelodysplasia (MDS))
  4. * Treatment-related
  5. * Complete Remission (CR1) with poor or intermediate-risk cytogenetics or molecular markers (e.g. Flt 3 mutation, 11q23, del 5, del 7, TP53 mutations, complex cytogenetics)
  6. * Participant must be in CR1, CR2, CR3 or CRi
  7. * Acute lymphoblastic leukemia (ALL)
  8. * Poor-risk cytogenetics (e.g., t(9;22)or 11q23 rearrangements)
  9. * Presence of minimal disease by flow cytometry or PCR or Clonoseq after 2 or more cycles of chemotherapy
  10. * No CR within 4 weeks of initial treatment Participant must be in CR1, CR2, CR3, or CRi
  11. * Myelodysplastic syndromes (MDS), Intermediate, High or Very High Risk by the revised international prognostic scoring system (IPSS-R) or treatment related MDS.
  12. 2. Age \> 18 years
  13. 3. Participants without a suitable HLA-matched related or unrelated donor
  14. 4. Participant with the following suitable grafts:
  15. * A 4-8/8 HLA high resolution matched CB unit with a cell dose of 1.0x105 CD34 cells/kg.
  16. * A haplo-identical donor with a goal cell dose of \> 4.0x106 CD34cells/kg (minimum 2 x106 CD34/kg)
  17. 5. Concurrent Therapy for Extramedullary Leukemia or CNS Lymphoma: Concurrent therapy or prophylaxis for testicular leukemia, CNS leukemia including standard intrathecal chemotherapy and/or radiation therapy will be allowed as clinically indicated. Such treatment may continue until the planned course is completed. Participants must be in CNS remission at the time of protocol enrollment if there is a history of CNS involvement. Maintenance therapy after transplant is allowed.
  18. 6. Participants must have the ability to understand and the willingness to sign a written informed consent document.
  1. 1. Participants with inadequate Organ Function as defined by:
  2. * Creatinine clearance \< 40ml/min (Cockcroft-Gault)
  3. * Bilirubin \> 2X institutional upper limit of normal unless Gilbert syndrome
  4. * AST (SGOT) \> 3X institutional upper limit of normal
  5. * ALT (SGPT) \> 3X institutional upper limit of normal
  6. * Pulmonary function: DLCOc \< 60%
  7. * Cardiac: left ventricular ejection fraction \< 40%
  8. * ECOG \<2
  9. 2. Participants with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  10. 3. Pregnant or breastfeeding women are excluded from this study because chemotherapy involved with RIC have the significant potential for teratogenic or abortifacient effects.
  11. 4. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
  12. 5. Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
  13. 6. Prior autologous stem cell transplant or CAR-T within the preceding 6 months or prior allogeneic transplant.

Contacts and Locations

Study Contact

Leland Metheny, MD
CONTACT
216-844-0139
Leland.Metheny@uhhospitals.org

Principal Investigator

Leland Metheny, MD
PRINCIPAL_INVESTIGATOR
Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center

Study Locations (Sites)

Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

  • Leland Metheny, MD, PRINCIPAL_INVESTIGATOR, Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-29
Study Completion Date2030-02-25

Study Record Updates

Study Start Date2025-07-29
Study Completion Date2030-02-25

Terms related to this study

Keywords Provided by Researchers

  • Unmodified Haplo-Identical Graft with Cord Blood
  • post-transplant cyclophosphamide aGVHD prophylaxis

Additional Relevant MeSH Terms

  • aGVHD
  • Acute Myelogenous Leukemia
  • Acute Lymphocytic Leukemia
  • Myelodysplastic Syndromes