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NCT02962401: RemodelWM3

Efficacity of Idelalisib and Obinutuzumab in Patient With Relapsed Refractory Waldenstrom's Macroglobulinemia

Completed Phase 2 Last updated 29 August 2023
What this trial tests

Phase 2 trial testing Obinutuzumab in Waldenstrom Macroglobulinemia in 50 participants. Completed in 13 April 2023.

Timeline
7 March 2017
Primary endpoint
31 August 2020
13 April 2023

Quick facts

Lead sponsorFrench Innovative Leukemia Organisation
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment50
Start date7 March 2017
Primary completion31 August 2020
Estimated completion13 April 2023
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

French Innovative Leukemia Organisation — full company profile →

Who can join

18 and older, any sex, with Waldenstrom Macroglobulinemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prospective national multicenter open label phase II Remodel WM3 trial

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting PI3K in cancer: mechanisms and advances in clinical trials.
    Yang J, Nie J, Ma X, Wei Y, et al · · 2019 · cited 1142× · PMID 30782187 · DOI 10.1186/s12943-019-0954-x
  2. PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects.
    Mishra R, Patel H, Alanazi S, Kilroy MK, et al · · 2021 · cited 207× · PMID 33801659 · DOI 10.3390/ijms22073464
  3. Obinutuzumab and idelalisib in symptomatic patients with relapsed/refractory Waldenström macroglobulinemia.
    Tomowiak C, Poulain S, Herbaux C, Perrot A, et al · · 2021 · cited 21× · PMID 33961019 · DOI 10.1182/bloodadvances.2020003895
  4. Management of Waldenström macroglobulinemia in 2020.
    Castillo JJ, Treon SP. · · 2020 · cited 21× · PMID 33275726 · DOI 10.1182/hematology.2020000121
  5. The PI3Kδ-Selective Inhibitor Idelalisib Minimally Interferes with Immune Effector Function Mediated by Rituximab or Obinutuzumab and Significantly Augments B Cell Depletion In Vivo.
    Palazzo A, Herter S, Grosmaire L, Jones R, et al · · 2018 · cited 15× · PMID 29453281 · DOI 10.4049/jimmunol.1700323
  6. Six-year follow-up of phase II study exploring chemo-free treatment association with idelalisib and obinutuzumab in symptomatic relapsed/ refractory patients with Waldenström's macroglobulinemia.
    Tomowiak C, Poulain S, Nudel M, Feugier P, et al · · 2025 · cited 2× · PMID 39499299 · DOI 10.1007/s00277-024-06076-1
  7. Six-year follow-up of phase II study exploring chemo-free treatment association with idelalisib and obinutuzumab in symptomatic relapsed/ refractory patients with Waldenström’s macroglobulinemia
    Tomowiak C, Poulain S, Nudel M, Feugier P, et al · · 2024 · DOI 10.21203/rs.3.rs-4978701/v1

Verify or expand the search:

Other trials of Obinutuzumab

Trials testing the same drug.

Other recruiting trials for Waldenstrom Macroglobulinemia

Currently open trials in the same condition.

Other French Innovative Leukemia Organisation trials

Trials by the same sponsor.

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Data sources for this page

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