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NCT04604028: LCMALT

Lenalidomide and Low-dose Cyclophosphamide for MALT Lymphoma

Status unknown Phase 2 Last updated 27 October 2020
What this trial tests

Phase 2 trial testing Lenalidomide [Leavdo®] in Antibiotics-unresponsive MALT Lymphoma in 21 participants. Status unknown.

Timeline
10 November 2020
Primary endpoint
31 December 2022
31 December 2023

Quick facts

Lead sponsorNational Taiwan University Hospital
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment21
Start date10 November 2020
Primary completion31 December 2022
Estimated completion31 December 2023
Sites1 location across Taiwan

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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

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Other National Taiwan University Hospital trials

Trials by the same sponsor.

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