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CHOP vs GEM-P in 1st Line Treatment of T-cell Lymphoma, Multicentre Phase II Study

NCT01719835 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2018-03-15

No results posted yet for this study

Summary

This is a randomised, open-label phase II study comparing GEM-P chemotherapy (experimental arm) with CHOP (control arm) in previously untreated T-cell lymphoma. Eligible patients will be randomised 1:1 between 4-weekly GEM-P or 3-weekly CHOP chemotherapy.

Conditions

  • Peripheral T-cell Lymphoma NOS
  • Anaplastic Large Cell Lymphoma, ALK-Negative
  • Angioimmunoblastic T-cell Lymphoma
  • Hepatosplenic Gamma/ Delta T-cell Lymphoma
  • Enteropathy-Associated T-Cell Lymphoma

Interventions

DRUG

Cyclophosphamide

750mg/m2 IV every 21 days

DRUG

Gemcitabine

1000mg/m2 IV Days 1, 8, 15 every 28 days

DRUG

Doxorubicin

50mg/m2 IV every 21 days

DRUG

Vincristine

1.4mg/m2 (max 2mg) IV every 21 days

DRUG

Prednisolone

100mg PO Days 1-5 every 21 days

DRUG

methylprednisolone

1000mg oral or IV Days 1-5 every 28 days

DRUG

Cisplatin

100mg/m2 IV Day 15 every 28 days

Sponsors & Collaborators

Principal Investigators

  • David Cunningham, MD FRCP · Royal Marsden NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2016-11-30
Completion
2022-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

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 NCT01719835 on ClinicalTrials.gov