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NCT02962401: RemodelWM3
Efficacity of Idelalisib and Obinutuzumab in Patient With Relapsed Refractory Waldenstrom's Macroglobulinemia
Phase 2 trial testing Obinutuzumab in Waldenstrom Macroglobulinemia in 50 participants. Completed in 13 April 2023.
31 August 2020
Quick facts
| Lead sponsor | French Innovative Leukemia Organisation |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 7 March 2017 |
| Primary completion | 31 August 2020 |
| Estimated completion | 13 April 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Obinutuzumab — full drug profile →
- Idelalisib — full drug profile →
Conditions studied
- Waldenstrom Macroglobulinemia — all drugs for Waldenstrom Macroglobulinemia →
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):
-
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 -
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 -
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 -
Management of Waldenström macroglobulinemia in 2020.
Castillo JJ, Treon SP. · · 2020 · cited 21× · PMID 33275726 · DOI 10.1182/hematology.2020000121 -
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 -
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 -
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:
- PubMed search for NCT02962401
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Waldenstrom Macroglobulinemia
Currently open trials in the same condition.
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- NCT06561347 — Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM · Phase 2 · recruiting
- NCT06510491 — Epcoritamab in Previously Treated WM · Phase 2 · recruiting
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Other French Innovative Leukemia Organisation trials
Trials by the same sponsor.
- NCT07007052 — Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Bl · Phase 2 · not yet recruiting
- NCT06547866 — Study Evaluating the Efficacy and Tolerance of a Zanubrutinib and BGB-11417 Combination in Patients Previously Treated f · Phase 2 · not yet recruiting
- NCT06377579 — OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia · recruiting
- NCT06263387 — Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible · recruiting
- NCT06186648 — Evaluation of Treatment by Glofitamab in Combination With Rituximab or Obinutuzumab Plus CHOP in Patients With RIchter S · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02962401 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by French Innovative Leukemia Organisation
- Last refreshed: 29 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02962401.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing