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NCT04635683
Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma
Phase 1 trial testing Lenalidomide in Recurrent B-Cell Non-Hodgkin Lymphoma. Withdrawn.
31 December 2023
Quick facts
| Lead sponsor | Yazeed Sawalha |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 30 September 2022 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2024 |
Drugs / interventions tested
- Lenalidomide — full drug profile →
- Ublituximab — full drug profile →
- Umbralisib — full drug profile →
Conditions studied
- Recurrent B-Cell Non-Hodgkin Lymphoma — all drugs for Recurrent B-Cell Non-Hodgkin Lymphoma →
- Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue — all drugs for Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue →
- Recurrent Follicular Lymphoma — all drugs for Recurrent Follicular Lymphoma →
- Recurrent Grade 1 Follicular Lymphoma — all drugs for Recurrent Grade 1 Follicular Lymphoma →
Sponsor
Yazeed Sawalha
Who can join
18 and older, any sex, with Recurrent B-Cell Non-Hodgkin Lymphoma or Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I trial studies the safety and how effective the combination of ublituximab, umbralisib, and lenalidomide is in certain types of indolent (slow-growing) non-Hodgkin's lymphoma or mantle cell lymphoma. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide may also stop the growth of non-Hodgkin's lymphoma by blocking blood flow to the cancer. Umbralisib is designed to block a protein called PI3 kinase in order to stop cancer growth and cause changes in the immune system that may allow the immune system to better act against cancer cells. Ublituximab is an antibody that attaches to the lymphoma cells and triggers immune reactions that may result in the death of the targeted lymphoma cells.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
PI3K/Akt Pathway: The Indestructible Role of a Vintage Target as a Support to the Most Recent Immunotherapeutic Approaches.
Caforio M, de Billy E, De Angelis B, Iacovelli S, et al · · 2021 · cited 29× · PMID 34439194 · DOI 10.3390/cancers13164040 -
Follicular Lymphoma: a Focus on Current and Emerging Therapies
Cahill KE, Smith SM. · · 2022 · cited 25× · PMID 35180337 · DOI 10.46883/2022.25920946 -
Evolving therapeutic landscape in follicular lymphoma: a look at emerging and investigational therapies.
Hanel W, Epperla N. · · 2021 · cited 22× · PMID 34193230 · DOI 10.1186/s13045-021-01113-2 -
Relapsed Mantle Cell Lymphoma: Current Management, Recent Progress, and Future Directions.
Bond DA, Martin P, Maddocks KJ. · · 2021 · cited 15× · PMID 33799484 · DOI 10.3390/jcm10061207 -
WNT signaling in cancer: molecular mechanisms and potential therapies.
Liang J, Pan Y, Yang J, Zeng D, et al · · 2025 · cited 2× · PMID 41120801 · DOI 10.1186/s43556-025-00327-x
Verify or expand the search:
- PubMed search for NCT04635683
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07465029 — A Study of Incidence, Treatment Patterns, and Outcomes in Transfusion-dependent Lower-risk Myelodysplastic Syndromes in · active not recruiting
- NCT07261163 — Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma · Phase 2 · not yet recruiting
- NCT06910124 — Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Neg · Phase 2 · recruiting
Other recruiting trials for Recurrent B-Cell Non-Hodgkin Lymphoma
Currently open trials in the same condition.
- NCT06723457 — Epcoritamab and Lenalidomide in Treating Patients With Refractory or Relapsed Immunodeficiency-Related Large B-Cell Lymp · Phase 2 · active not recruiting
- NCT05801913 — Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) for the Treatment of Inter · Phase 1 · recruiting
- NCT05453396 — Loncastuximab Tesirine for the Treatment of Relapsed or Refractory B-Cell Malignancies · Phase 2 · recruiting
- NCT05432635 — Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) Following Stem Cell Transp · Phase 1 · recruiting
- NCT05507541 — TTI-622 in Combination With Pembrolizumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma · Phase 2 · active not recruiting
Other Yazeed Sawalha trials
Trials by the same sponsor.
- NCT06536049 — Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma · Phase 1, PHASE2 · recruiting
- NCT04850495 — Zanubrutinib in Combination With R-PolaCHP (ZaR-PolaCHP) for Newly Diagnosed Diffuse Large B-Cell Lymphoma · Phase 1 · suspended
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 NCT04635683 (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 Yazeed Sawalha
- Last refreshed: 30 September 2022
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/NCT04635683.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing