deltatrials
Terminated PHASE1 INTERVENTIONAL NCT00005787

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)

Updated 6 times since 2017 Last updated: May 31, 2012 Started: Sep 30, 1999 Primary completion: Jan 31, 2002 Completion: Jan 31, 2002
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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This PHASE1 trial investigates Lymphoma and Neutropenia and is currently terminated or withdrawn.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

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated~Jan 2026 – present · 3 months · monthly snapshotTerminated

Change History

6 versions recorded
  1. Jan 2026 — Present [monthly]

    Terminated PHASE1

  2. Sep 2024 — Present [monthly]

    Terminated PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1

  4. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE1

  5. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE1

Show 1 earlier version
  1. 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

Sponsor contact:
  • National Cancer Institute (NCI)
  • Northwestern University
Data source: Northwestern University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations