RECRUITING

HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation with Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis

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Conditions

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAcute LeukemiaMyelodysplastic SyndromesChronic Myeloid LeukemiaChronic Lymphocytic LeukemiaMyeloproliferative NeoplasmLymphomaChronic Myelomonocytic LeukemiaPro-Lymphocytic LeukemiaMyelofibrosisLeukemiaHematologic DiseasesPreleukemiaPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia , Lymphocytic, Chronic, B-CellLeukemia, Myeloid, AcuteLeukemia, Biphenotypic, AcuteNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DisordersBone Marrow DiseasesPrecancerous ConditionsLeukemia, LymphoidLeukemia, B-CellLeukemia, MyeloidCyclophosphamideMesnaTacrolimusBusulfanFludarabineTotal Body IrradiationMelphalanMycophenolate mofetilReduced Dose CyclophosphamideImmunosuppressive AgentsImmunologic FactorsPhysiological Effects of DrugsHematopoietic Stem Cell TransplantationPeripheral Blood Stem CellsUnrelated Donors

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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 goal of this clinical trial is to determine the effectiveness of Reduced Dose Post-Transplant Cyclophosphamide (PTCy) in patients with hematologic malignancies after receiving an HLA-Mismatched Unrelated Donor (MMUD) . The main question\[s\] it aims to answer are: * Does a reduced dose of PTCy reduce the occurrence of infections in the first 100 days after transplant? * Does a reduced dose of PTCy maintain the same level of protection against Graft Versus Host Disease (GvHD) as the standard dose of PTCy?

Official Title

A Phase II Study of Reduced Dose Post Transplantation Cyclophosphamide As GvHD Prophylaxis in Adult Patients with Hematologic Malignancies Receiving HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

Quick Facts

Study Start:2023-12-08
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06001385

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. Age ≥ 18 years and \< 66 years (chemotherapy-based conditioning) or \< 61 years (total body irradiation \[TBI\]-based conditioning) at the time of signing informed consent
  2. 2. Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and institutional requirements.
  3. 3. Stated willingness to comply with all study procedures and availability for the duration of the study.
  4. 4. Planned MAC regimen as defined per study protocol
  5. 5. Available partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with age ≥ 18 and ≤ 40 years (≤ 35 preferred).
  6. 6. Product planned for infusion is MMUD T-cell replete PBSC allograft
  7. 7. HCT-CI \< 5. The presence of prior malignancy will not be used to calculate HCT-CI for this trial to allow for the inclusion of patients with secondary or therapy-related AML or MDS.
  8. 8. One of the following diagnoses:
  9. 1. Acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or other acute leukemia in 1st remission or beyond with ≤ 5% marrow blasts and no circulating blasts or evidence of extra-medullary disease. Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.
  10. 2. Patients with MDS with no circulating blasts and with \< 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \< 5% or 5-10% blasts in MDS). Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.
  11. 9. Cardiac function: Left ventricular ejection fraction ≥ 45% based on most recent echocardiogram or multi-gated acquisition scan (MUGA) results.
  12. 10. Estimated creatinine clearance ≥ 45mL/min calculated by equation.
  13. 11. Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin \> 50% and forced expiratory volume in first second (FEV1) predicted \> 50% based on most recent pulmonary function test (PFT) results
  14. 12. Liver function acceptable per local institutional guidelines
  15. 13. KPS of ≥ 70%
  1. 1. Donor unwilling or unable to donate.
  2. 2. Recipient positive for HLA antibodies against a mismatched HLA in the selected donor determined by the presence of donor specific HLA antibodies (DSA) to any mismatched HLA allele/antigen at any of the following loci (HLA-A, -B, -C, -DRB1, DRB3, DRB4, DRB5, -DQA1, - DQB1, -DPA1, -DPB1) with median fluorescence intensity (MFI) \>3000 by microarray-based single antigen bead testing. In patients receiving red blood cell or platelet transfusions, DSA evaluation must be performed or repeated post-transfusion and prior to donor mobilization and initiation of recipient preparative regimen.

Contacts and Locations

Study Contact

Brandan Butler, MBA
CONTACT
763-406-3280
bbutler@nmdp.org
OPTIMIZE Study Team
CONTACT
OPTIMIZE@NMDP.ORG

Principal Investigator

Steven Devine, MD
PRINCIPAL_INVESTIGATOR
NMDP
Jeffery Auletta, MD
STUDY_CHAIR
NMDP

Study Locations (Sites)

Mayo Clinic Arizona
Phoenix, Arizona, 85054
United States
City of Hope
Duarte, California, 91010
United States
Stanford University
Stanford, California, 94305
United States
Colorado Blood Cancer Institute at Presbyterian St. Luke's
Denver, Colorado, 80218
United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
United States
University of Miami Sylvester Cancer Center
Miami, Florida, 33136
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55902
United States
Barnes Jewish Hospital / Washington University
Saint Louis, Missouri, 63110
United States
Memorial Sloan Kettering Cancer Center - Adults
New York, New York, 10065
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
Ohio State Medical Center
Columbus, Ohio, 43210
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
United States
TriStar Centennial
Nashville, Tennessee, 37203
United States
St. David's South Austin Medical Center
Austin, Texas, 78704
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Methodist Hospital San Antonio
San Antonio, Texas, 78229
United States
University of Virginia Health System
Charlottesville, Virginia, 22908
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Center for International Blood and Marrow Transplant Research

  • Steven Devine, MD, PRINCIPAL_INVESTIGATOR, NMDP
  • Jeffery Auletta, MD, STUDY_CHAIR, NMDP

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 Date2023-12-08
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-12-08
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Lymphoma
  • Leukemia
  • Hematologic Diseases
  • Myelodysplastic Syndromes
  • Preleukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia , Lymphocytic, Chronic, B-Cell
  • Leukemia, Myeloid, Acute
  • Leukemia, Biphenotypic, Acute
  • Neoplasms by Histologic Type
  • Neoplasms
  • Lymphoproliferative Disorders
  • Lymphatic Diseases
  • Immunoproliferative Disorders
  • Immune System Disorders
  • Bone Marrow Diseases
  • Precancerous Conditions
  • Leukemia, Lymphoid
  • Leukemia, B-Cell
  • Leukemia, Myeloid
  • Cyclophosphamide
  • Mesna
  • Tacrolimus
  • Busulfan
  • Fludarabine
  • Total Body Irradiation
  • Melphalan
  • Mycophenolate mofetil
  • Reduced Dose Cyclophosphamide
  • Immunosuppressive Agents
  • Immunologic Factors
  • Physiological Effects of Drugs
  • Hematopoietic Stem Cell Transplantation
  • Peripheral Blood Stem Cells
  • Unrelated Donors

Additional Relevant MeSH Terms

  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Acute Leukemia
  • Myelodysplastic Syndromes
  • Chronic Myeloid Leukemia
  • Chronic Lymphocytic Leukemia
  • Myeloproliferative Neoplasm
  • Lymphoma
  • Chronic Myelomonocytic Leukemia
  • Pro-Lymphocytic Leukemia
  • Myelofibrosis