Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
NCT Number: NCT02916979
This study is examining a chemotherapy regimen and immune suppressive medications in the setting of an allogeneic stem cell transplant. A pilot clinical trial to characterize the incidence, prevalence and function of myeloid-derived suppressor cells (MDSCs) and immune checkpoint regulators (V-domain Ig Suppressor of T-cell Activation [VISTA], cytotoxic T-lymphocyte- associated protein 4 [CTLA-4], programmed death-ligand 1 [PD-L1]) during early immune recovery following an allogeneic stem cell transplant. The site will use a myeloablative regimen of fludarabine with busulfan, adopted from CALGB 100801, to define clinical endpoints, including engraftment, 100 day survival and one year survival (Objective #1). The site will characterize the incidence, prevalence and function of MDSCs and immune checkpoint regulators in patients' blood and bone marrow following transplantation (Objective #2). The site will correlate these laboratory results with clinical outcomes and the incidence of graft-versus-host disease (GVHD). As an exploratory aim, in those patients experiencing GVHD and requiring treatment, the site will define the MDSCs frequency and checkpoint regulator expression and correlate these results with the patient's response to GVHD therapy.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Lebanon, New Hampshire, 03756, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Donor eligibility
Donor Exclusion Criteria
Fludarabine: 30 mg/m2 daily for 5 days
Busulfan: 100 mg/m2 daily for 4 days
Rabbit ATG:
Related donors: 1.5 mg/kg daily x 2 days (on days -6 and -5) Unrelated donors: 1.5 mg/kg on day - 6 2 mg/kg on day -5 2.5 mg/kg on day -4
Methotrexate:
Related donors: 5 mg/m2 on days 1, 3 and 6 Unrelated donors: 5 mg/m2 on days 1, 3, 6 and 11
Time frame: 100 Days
100-Day survival of patients
Time frame: 100 Days
Time to marrow engraftment (defined as absolute neutrophil count > 500/mm3 and platelets > 20,000/mcl for three consecutive days (count first day as engraftment)
Time frame: 100 Days
Response to treatment at 100 days using standard international response criteria, based on CIBMTR definitions.
Time frame: 365 Days
Response to treatment at one year using standard international response criteria, based on CIBMTR definitions.
Time frame: 365 Days
One year survival
Time frame: 100 Days
Treatment-related mortality in the first 100 days
Time frame: 365 Days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 365 Days
Incidence of acute and chronic GVHD
Time frame: 30, 60, and 90 Days
Donor-recipient chimerism following transplant at Days 30, 60 and 90.
Dartmouth-Hitchcock Medical Center
Other
A Pilot Trial Examining Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic Stem Cell Transplant Recipients Using Myeloablative Busulfan and Fludarabine
Acronym: FluBuATG
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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