Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma
Ex Vivo Expanded Peripheral Blood Mononuclear Cells for the Elimination of Neutropenia Associated With High Dose Chemotherapy
Sponsor: National Cancer Institute (NCI)
Terminated
Per PI due to poor/inadequate accrual.
This PHASE1 trial investigates Lymphoma and Neutropenia and is currently terminated or withdrawn. National Cancer Institute (NCI) leads this study, which shows 6 recorded versions since 1999 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)OBJECTIVES:
* Determine the toxicity of ex vivo expanded peripheral blood mononuclear cells (EVE PBMNC) as a supplement to high-dose chemotherapy and conventional autograft in patients with relapsed or refractory non-Hodgkin's lymphoma.
* Compare the effect of EVE PBMNC on white blood cell, red blood cell, and platelet recovery in patients on this study vs historical controls, matched by protocol, disease status, and prior therapy.
* Determine the optimal duration of culture and time of harvest for the production of neutrophils in vivo.
* Determine the relationships between length of culture, immunophenotype, and clinical outcome.
* Determine the required numbers of white blood cell precursors for clinical efficacy.
* Assess the need for multiple transfusions of EVE PBMNC during the post-transplantation period.
OUTLINE: Autologous peripheral blood mononuclear cells (PBMNC) are harvested. Unselected PBMNC are cultured and expanded ex vivo in flt3 ligand, interleukin-3, filgrastim (G-CSF), sargramostim (GM-CSF), and epoetin alfa for 13 days. Expanded PBMNC are reinfused on day 0.
Patients are followed monthly for 1 year.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
OBJECTIVES:
* Determine the toxicity of ex vivo expanded peripheral blood mononuclear cells (EVE PBMNC) as a supplement to high-dose chemotherapy and conventional autograft in patients with relapsed or refractory non-Hodgkin's lymphoma. * Compare the effect of EVE PBMNC on white blood cell, red blood cell, and platelet recovery in patients on this study vs historical controls, matched by protocol, disease status, and prior therapy. * Determine the optimal duration of culture and time of harvest for the production of neutrophils in vivo. * Determine the relationships between length of culture, immunophenotype, and clinical outcome. * Determine the required numbers of white blood cell precursors for clinical efficacy. * Assess the need for multiple transfusions of EVE PBMNC during the post-transplantation period.
OUTLINE: Autologous peripheral blood mononuclear cells (PBMNC) are harvested. Unselected PBMNC are cultured and expanded ex vivo in flt3 ligand, interleukin-3, filgrastim (G-CSF), sargramostim (GM-CSF), and epoetin alfa for 13 days. Expanded PBMNC are reinfused on day 0.
Patients are followed monthly for 1 year.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE1
-
Sep 2024 — Present [monthly]
Terminated PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE1
-
Jan 2021 — Jul 2024 [monthly]
Terminated PHASE1
-
Jun 2018 — Jan 2021 [monthly]
Terminated PHASE1
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Terminated PHASE1
First recorded
Sep 1999
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Cancer Institute (NCI)
- Northwestern University
For direct contact, visit the study record on ClinicalTrials.gov .