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Lenalidomide and Low-dose Cyclophosphamide for MALT Lymphoma

NCT04604028 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-10-27

No results posted yet for this study

Summary

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.

Conditions

  • Antibiotics-unresponsive MALT Lymphoma
  • Relapsed MALT Type Extranodal Marginal Zone B-Cell Lymphoma
  • Refractory Extranodal Marginal Zone B-Cell Lymphoma (MALT)

Interventions

DRUG

Lenalidomide [Leavdo®]

Complete remission and partial remission rate

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Sung-Hsin Kuo, M.D.,Ph.D · National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-10
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04604028 on ClinicalTrials.gov