deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT00076752

Lymphocyte Depletion and Stem Cell Transplantation to Treat Severe Systemic Lupus Erythematosus

A Pilot Study of Intensified Lymphodepletion Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Systemic Lupus Erythematosus

Sponsor: National Cancer Institute (NCI)

Conditions Lupus Erythematosus, Systemic
Interventions Diphenhydramine Mesna Rituxan (rituximab) autologous hematopoietic stem cell transplantation cyclophosphamide filgrastim fludarabine phosphate immunologic technique laboratory biomarker analysis methylprednisolone
Updated 8 times since 2017 Last updated: Dec 9, 2020 Started: Jan 30, 2004 Primary completion: Oct 15, 2013 Completion: Oct 15, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Lupus Erythematosus, Systemic and is currently completed. National Cancer Institute (NCI) leads this study, which shows 8 recorded versions since 2004 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshotCompleted~Jun 2017 – ~Jun 2018 · 12 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshotCompleted~Feb 2021 – ~Jul 2024 · 41 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 24 months · monthly snapshotCompleted

Change History

8 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Feb 2021 — Jul 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Feb 2021 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

▶ Show 3 earlier versions

  1. Jun 2017 — Jun 2018 [monthly]

    Completed PHASE2

  2. Feb 2017 — Jun 2017 [monthly]

    Completed PHASE2

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Jan 2004

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)
Data source: National Institutes of Health Clinical Center (CC)

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

Study Locations