deltatrials
Terminated PHASE4 INTERVENTIONAL 2-arm NCT01283386

A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status

Prospective Randomized Study to Compare Efficacy and Safety of RFC-Lite (Rituximab, Fludarabine, Cyclophosphamide) Regimen With LR (Rituximab, Chlorambucil) as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Unfavorable Somatic Status

Sponsor: Hoffmann-La Roche

Updated 8 times since 2017 Last updated: Nov 23, 2018 Started: Apr 27, 2011 Primary completion: Mar 16, 2016 Completion: Mar 16, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

This trial was terminated. No reason was provided.

A PHASE4 clinical study on Lymphocytic Leukemia, Chronic, this trial is terminated or withdrawn. The trial is conducted by Hoffmann-La Roche and has accumulated 8 data snapshots since 2011. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Apr 2019 · 10 months · monthly snapshotCompleted~Apr 2019 – ~Jan 2021 · 21 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 10 months · monthly snapshotTerminated

Change History

8 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE4

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE4

  4. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE4

  5. Apr 2019 — Jan 2021 [monthly]

    Terminated PHASE4

    Status: CompletedTerminated

Show 3 earlier versions
  1. Jun 2018 — Apr 2019 [monthly]

    Completed PHASE4

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE4

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE4

    First recorded

Apr 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Hoffmann-La Roche
Data source: Hoffmann-La Roche

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