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NCT Number: NCT02988466

Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT

This is a single institution phase II study of a reduced intensity conditioning (RIC) followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with diagnosis of hematologic malignancy. Conditioning will consists of fludarabine, cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index (CI) >3. This study uses a two-stage phase II design with accrual goal of 84 patients, using 28 patients separately for arms A, C and D

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Key information

Conditions

Hematologic Malignancies Blood Protein Disorders Bone Marrow Diseases Bone Marrow Failure Disorders Burkitt Lymphoma Cardiovascular Diseases Chronic Disease DNA Virus Infections Dendritic Cell Sarcoma, Interdigitating Disease Attributes Epstein-Barr Virus Infections Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Histiocytic Disorders, Malignant Histiocytosis Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Multiple Myeloma Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasm, Residual Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Neoplastic Processes Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis Tumor Virus Infections Vascular Diseases Virus Diseases

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Karnofsky performance status of ≥70% or Lansky play score ≥ 70%
  • A related haploidentical bone marrow donor with up to 2 or 3 HLA locus-mismatches
  • The donor and recipient must be HLA identical for at least one haplotype (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1.
  • Adequate liver and renal function
  • Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%
  • Diffusion capacity corrected (DLCOcorr) > 40% predicted, and absence of O2 requirements
  • > 6 months after prior autologous transplant (if applicable)
  • Agrees to use contraception during study treatment
  • Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate)
  • Patients who are HIV+ must have undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation

Exclusion criteria

  • < 70 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
  • Pregnancy or breastfeeding
  • Current active and uncontrolled serious infection
  • Acute leukemia in morphologic relapse/persistent disease defined as > 5% blasts in normocellular bone marrow OR any % blasts if blasts have unique morphologic markers (e.g. Auer rods).
  • CML in blast crisis
  • Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressive on salvage therapy.
  • stable non-bulky disease is acceptable.
  • Active central nervous system malignancy

Criteria For Donor Selection:

  • Donors must be HLA-haploidentical relatives of the patient, defined as having a shared HLA haplotype between donor and patient at HLA-A, -B, -C, and -DRB1.
  • Eligible donors (14-70 years old) include biological children, siblings or half siblings, or parents, able and willing to undergo bone marrow harvesting.
  • For donors <18 years, the maximum recipient weight (actual body weight) should not exceed 1.25 times the donor weight (actual body weight)1 In addition, bone marrow product volume should be limited to 20 ml/kg donor weight for donors <18 years.

Treatment and study plan

Haplo HCT <55 years old

Biological
  • Fludarabine (Flu)
  • Cyclophosphamide (Cy)
  • Melphalan (Mel)
  • Total body irradiation (TBI)
  • Non-T-cell depleted donor bone marrow stem cell infusion Day 0

Other names: HLA-haploidentical related hematopoietic cells transplant

Haplo HCT ≥55 years old

Biological
  • Fludarabine (Flu)
  • Cyclophosphamide (Cy)
  • Melphalan (Mel): Dose reduction by 30%
  • Total body irradiation (TBI)
  • Non-T-cell depleted donor bone marrow stem cell infusion

Other names: HLA-haploidentical related hematopoietic cells transplant

GVHD Prophylaxis

Drug
  • Cyclophosphamide (Cy)
  • Tacrolimus (Tac)
  • Mycophenolate mofetil (MMF)

Haplo HCT ≥55 and < 65 years old

Biological
  • Fludarabine (Flu)
  • Cyclophosphamide (Cy)
  • Melphalan (Mel)
  • Total body irradiation (TBI)
  • non-T-cell depleted donor bone marrow stem cells

Other names: HLA-haploidentical related hematopoietic cells transplant

Haplo HCT ≥65 and ≤75 years old

Biological
  • Fludarabine (Flu)
  • Cyclophosphamide (Cy)
  • Total body irradiation (TBI)

Other names: HLA-haploidentical related hematopoietic cells transplant

Primary outcomes

  1. Disease-free Survival (DFS)

    Time frame: 1 year

    Percentage of participants that were disease-free survival (DFS) at 1 year post-transplant

Secondary outcomes

  1. Incidence of Grade II-IV and Grade III-IV Acute Graft Versus-host-disease (GVHD)

    Time frame: day 100

    Percentage of participants with incidence of grade II-IV and grade III-IV acute graft versus-host-disease (GVHD).

  2. Treatment Related Mortality (TRM)

    Time frame: 6 month, 1 and 2 year

    Percentage of participants experiencing treatment related mortality (TRM).

  3. Relapse Incidence

    Time frame: 1 and 2 year

    Percentage of participants experiencing a relapse incidence at 1 and 2 years.

  4. Incidence of Serious Fungal and Viral Infection

    Time frame: at day 100 and 1 year

    Percentage of participants experiencing incidence of serious fungal and viral infection post-HCT

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Official study title

Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies

Important dates

Study start
2017
Primary completion
2023
Study completion
2025
First posted
Dec 9, 2016
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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