deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT00842595

Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas

Phase II Study of Treatment of Relapsed Agressive Lymphomas

Sponsor: French Innovative Leukemia Organisation

Updated 6 times since 2017 Last updated: Jul 23, 2013 Started: Dec 31, 2003 Primary completion: Nov 30, 2009 Completion: May 31, 2010
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 Diffuse Large B-Cell Lymphoma and is currently completed. French Innovative Leukemia Organisation leads this study, which shows 6 recorded versions since 2003 — 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)

Phase II study of the efficacy and toxicity of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma. The study intervention is an administration of 3 courses of the abovementioned drugs, witch doses are detailed below. Remission is assessed and the investigator is free to proceed with any kind of consolidation , he decides best for the patient( high dose or standard chemotherapy). The addition of Rituximab the the NIMP protocol is warranted on the basis of previous publications wtich have shown a significant advantage in addition to chemotherapy in complete remission rate and in overall survival. Navelbine has shown an interesting activity in lymphoma relapse. Mitoxantrone has a good toxicity profile for patients who have prevously received anthracyclines, and there is not so much cross resistance between the two drugs. Ifosfamide is commonly used in the treatment of relapsed and refractory lymphoma, because of its low hematologic toxicity profile and good antitumor activity.

Phase II study of the efficacy and toxicity of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma.

The study intervention is an administration of 3 courses of the abovementioned drugs, witch doses are detailed below. Remission is assessed and the investigator is free to proceed with any kind of consolidation , he decides best for the patient( high dose or standard chemotherapy).

The addition of Rituximab the the NIMP protocol is warranted on the basis of previous publications wtich have shown a significant advantage in addition to chemotherapy in complete remission rate and in overall survival.

Navelbine has shown an interesting activity in lymphoma relapse. Mitoxantrone has a good toxicity profile for patients who have prevously received anthracyclines, and there is not so much cross resistance between the two drugs.

Ifosfamide is commonly used in the treatment of relapsed and refractory lymphoma, because of its low hematologic toxicity profile and good antitumor activity.

Status Flow

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

Change History

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

    Completed PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE2

    First recorded

Dec 2003

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • French Innovative Leukemia Organisation
Data source: French Innovative Leukemia Organisation

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

Study Locations