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NCT04604028: LCMALT
Lenalidomide and Low-dose Cyclophosphamide for MALT Lymphoma
Phase 2 trial testing Lenalidomide [Leavdo®] in Antibiotics-unresponsive MALT Lymphoma in 21 participants. Status unknown.
31 December 2022
Quick facts
| Lead sponsor | National Taiwan University Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 10 November 2020 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Lenalidomide [Leavdo®] — full drug profile →
Conditions studied
- Antibiotics-unresponsive MALT Lymphoma — all drugs for Antibiotics-unresponsive MALT Lymphoma →
- Relapsed MALT Type Extranodal Marginal Zone B-Cell Lymphoma — all drugs for Relapsed MALT Type Extranodal Marginal Zone B-Cell Lymphoma →
- Refractory Extranodal Marginal Zone B-Cell Lymphoma (MALT) — all drugs for Refractory Extranodal Marginal Zone B-Cell Lymphoma (MALT) →
Sponsor
National Taiwan University Hospital
Who can join
18 and older, any sex, with Antibiotics-unresponsive MALT Lymphoma or Relapsed MALT Type Extranodal Marginal Zone B-Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Considering that lenalidomide and cyclophosphamide are found to have anti-tumor effects in MALT lymphoma, the investigators speculated that combined lenalidomide and low-dose cyclophosphamide can increase the overall response rate as well as dural time of tumor remission, and avoid alternative treatments, including radiotherapy or chemotherapy-related adverse effects in antibiotics-unresponsive, relapsed or refractory extranodal MALT lymphoma. Therefore, in this proposal, the investigators will design a prospective phase II study to evaluate the treatment efficacies of combination of oral lenalidomide and low-dose cyclophosphamide (LC: lenalidomide \[Leavdo®\] 15 mg daily, day 1 to day 21; cyclophosphamide \[Endoxan\] 50 mg daily, day 1 to day 21; courses will be repeated every 28 days) in patients with antibiotics-unresponsive, relapsed or refractory extranodal MALT lymphoma.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current Status of the Spectrum and Therapeutics of <i>Helicobacter pylori</i>-Negative Mucosa-Associated Lymphoid Tissue Lymphoma.
Kuo SH, Yeh KH, Lin CW, Liou JM, et al · · 2022 · cited 13× · PMID 35205754 · DOI 10.3390/cancers14041005 -
Two rare cases of bronchus-associated lymphoid tissue lymphoma successfully treated with rituximab-bendamustine.
Panitz N, Gerhardt K, Becker C, Schleife H, et al · · 2021 · cited 2× · PMID 34401153 · DOI 10.1002/ccr3.4557
Verify or expand the search:
- PubMed search for NCT04604028
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04604028 (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 National Taiwan University Hospital
- Last refreshed: 27 October 2020
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/NCT04604028.
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