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NCT03480360CompletedPhase 3

Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression

Haploidentical Allogeneic Peripheral Blood Transplantation: Clinical Trial and Laboratory Correlates Examining Checkpoint Immune Regulators' Expression

Source: ClinicalTrials.gov · Last updated 17 Jul 2026

Brief summary (registry, in English)

The standard Johns Hopkins' regimen will be used in study subjects, with the use of donor peripheral blood stem cells, rather than marrow. Clinical outcomes will be defined while focusing efforts on immune reconstitution focusing on immune checkpoint regulators after a related haploidentical stem cell transplant.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
21 (actual)
First submitted
8 Jan 2018
Start date
28 Mar 2018
Primary completion date
14 Feb 2025
Lead sponsor
Dartmouth-Hitchcock Medical Center
NCT number
NCT03480360

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 21
  • From 28 Mar 2018 to the primary completion date, 14 Feb 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Psychiatric disorder or a mental deficiency of the patient that is sufficiently severe to make compliance with the treatment unlikely, and making informed consent impossible.
  • Major anticipated illness or organ failure incompatible with survival from bone marrow transplant.
  • History of refractory systemic infection
    • DONOR ELIGIBILITY
  • HIV or active Hep B or C in the donor
  • A donor with a psychiatric disorder or mental deficiency that makes compliance with the procedure unlikely and informed consent impossible

Lab values

  • Human leukocyte antigen (HLA) haplo-identical matched related.

Age

  • There is no age restriction for the donor

Other

  • The donor must be healthy and must be willing to serve as a donor, based on standard National Marrow Donor Program (NMDP) guidelines and DHMC SOP - Donor Evaluation (Appendix)
  • The donor must have no significant co-morbidities that would put the donor at marked increased risk
  • Informed consent must be signed by donor
    • DONOR EXCLUSION CRITERIA
  • The NMDP guidelines for exclusion criteria will be used (Appendix). In addition, the following donors are NOT eligible:
  • Pregnant or lactating donor
  • Donor unfit to receive G-CSF and undergo apheresis

Who the study is looking for

  • Age: less than 75 years
  • The patient must be approved for transplant by the treating transplant physician. This includes completion of their pre-transplant workup, as directed by standard Dartmouth-Hitchcock Medical Center (DHMC) Standard Operating Procedure (SOP) (DHMC SOP - Pre-transplant Evaluation of allogeneic recipient (Appendix).
  • The patient must have a disease (listed below) with treatment-responsiveness that the treating transplant physician believes will benefit from an allogeneic stem cell transplant. The diseases include:
  • Acute leukemia - Acute Myeloid Leukemia, Acute Lymphocytic Leukemia
  • Chronic leukemia - Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia
  • Myelodysplasia
  • Myeloproliferative disorder
  • Myelofibrosis
  • Lymphoma - Non-Hodgkin's Lymphoma or Hodgkin's disease
  • Plasma cell disorder, including myeloma, Waldenstrom's Macroglobulinemia
  • Donor availability- the patient must have an identified RELATED haplo-identical donor
  • No Human Immunodeficiency Virus infection or active hepatitis B or C
  • Eastern Cooperative Oncology Group performance status: 0-2
  • Diffusing capacity of carbon monoxide (DLCO) greater than or equal to 40 % predicted
  • Left ventricular ejection fraction greater than or equal to 40%
  • Serum bilirubin \< 2x upper limit of normal; transaminases \< 3x normal at the time of transplant
  • No active or uncontrollable infection
  • In female, a negative pregnancy test if experiencing menstrual periods
  • No major organ dysfunction precluding transplantation
  • No evidence of an active malignancy that would limit the patient's survival to less than 2 years. (If there is any question, the PI can make a decision).

Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center
Coordinator of this site? Confirm its status
LebanonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.