MedTrace Logo

Lenalidomide and Gemcitabine in Relapsed or Refractory Peripheral T-cell Lymphomas

NCT05105412 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-07-08

No results posted yet for this study

Summary

This is a single country multi-center, open-label phase Ib/II single-arm study in relapsed or refractory PTCL patients. Patients will be treated with the combination of lenalidomide and gemcitabine until disease progression, intolerable toxicity, or patient withdrawal.

Conditions

  • Peripheral T-cell Lymphomas (PTCL)

Interventions

DRUG

Lenalidomide and Gemcitabine (Dose level 11)

lenalidomide 25 mg/day D1-D14 and gemcitabine 1000 mg/m2 D1, D8

DRUG

Lenalidomide and Gemcitabine (Dose level 21)

lenalidomide 15 mg/day D1-D14 and gemcitabine 1000 mg/m2 D1, D8

DRUG

Lenalidomide and Gemcitabine (Dose level 31)

lenalidomide 10 mg/day D1-D14 and gemcitabine 1000 mg/m2 D1, D8

DRUG

Lenalidomide and Gemcitabine (Dose level 41)

lenalidomide 10 mg/day D1-D14 and gemcitabine 800 mg/m2 D1, D8

Sponsors & Collaborators

  • National Taiwan University Hospital

    collaborator OTHER

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • China Medical University Hospital

    collaborator OTHER

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Tsang-Wu Liu · Taiwan Cooperative Oncology Group, NHRI

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2024-03-30
Completion
2024-03-30

Countries

  • Taiwan

Study Locations

More Related Trials

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 NCT05105412 on ClinicalTrials.gov