NCT03480360

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

We propose a clinical trial to define clinical endpoints, including engraftment, 100-day survival and one year survival (Objective #1). We will characterize the incidence, prevalence and function of immune checkpoint regulators in patients' blood and bone marrow following transplantation (Objective #2). We will correlate these laboratory results with clinical outcomes and the incidence of GVHD. As an exploratory aim, in those patients experiencing GVHD and requiring treatment, we will define the frequency/expression of checkpoint regulator expression and correlate these results with the patient's response to GVHD therapy.

Conditions

• Acute Myeloid Leukemia
• Chronic Lymphocytic Leukemia
• Chronic Myeloid Leukemia
• Myelodysplasia
• Myeloproliferative Disorder
• Myelofibrosis
• Lymphoma
• Lymphoma, Non-Hodgkin
• Plasma Cell Disorder

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)
DRUG	Fludarabine	30 mg/m2 daily for 5 days
RADIATION	Total Body Irradiation	200 centigray (cGy) for one day (day -1)
DRUG	Tacrolimus	1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.
DRUG	cellcept	dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.
DRUG	g-csf	5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \> 1000/mcL for 3 days.
PROCEDURE	Peripheral Blood Transplant	cell dose goal: \< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight

Timeline

• Start date: 2018-03-28
• Primary completion: 2025-02-14
• Completion: 2026-10-17
• First posted: 2018-03-29
• Last updated: 2026-02-19
• Results posted: 2024-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study