Cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) versus gemcitabine, cisplatin and methyl prednisolone (GEM-P) in the first line treatment Of T-cell Lymphoma, a multicentre randomised phase II study

Cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) versus gemcitabine, cisplatin and methyl prednisolone (GEM-P) in the first line treatment Of T-cell Lymphoma, a multicentre randomised phase II study - CHEMO-T

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004146-18-GB

Enrollment

186

Registered

2011-10-14

Start date

2011-11-09

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T-cell Lymphoma MedDRA version: 14.0 Level: HLT Classification code 10001414 Term: Adult T-cell lymphomas/leukaemias System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Product Name: Gemcitabine Pharmaceutical Form: Powder for solution for infusion Product Name: Methylprednisolone Pharmaceutical Form: Tablet INN or Proposed INN: Methylprednisolone Product Name: Cis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Previously untreated, histologically proven T-cell Lymphoma (any of the following): - Peripheral T-cell lymphoma Not Otherwise Specified (PTCL NOS) - Systemic Anaplastic large cell lymphoma (ALCL) ALK negative cases only - Angioimmunoblastic T-cell lymphoma - Hepatosplenic gamma/ delta T-cell lymphoma 2. Bulky stage I not being considered for reduced chemotherapy plus involved field radiotherapy or stage II, III or IV. 3. Age =18 years on the day of signing informed consent. 4. WHO performance status 0, 1 or 2. 5. Baseline 18FDG-PET scans must demonstrate FDG avid disease compatible with CT defined anatomical tumour sites. 6. Adequate bone marrow, cardiac, renal, hepatic and respiratory function. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36

Exclusion criteria

Exclusion criteria: 1. Documented or symptomatic central nervous system involvement or leptomeningeal disease. 2. Patients with negative FDG-PET/CT scan at baseline 3. Any other clinically significant disease or co-morbidity which may adversely affect the safe delivery of treatment within this trial. 4. Prior malignancy within the last 5 years 5. Treatment with another investigational agent within 30 days of commencing study treatment. 6. Known positive tests for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or active hepatitis B infection. 7. Patients with poorly controlled diabetes mellitus

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the efficacy of the GEM-P chemotherapy regimen with CHOP chemotherapy in the first-line treatment of T-cell lymphoma.;Secondary Objective: To investigate between both arms: • Rate of metabolic complete response and partial response • Best achieved response rate by CT • Toxicity of treatment • Overall survival (OS) • Progression Free Survival (PFS);Primary end point(s): To compare the metabolic complete response rate of GEM-P with CHOP chemotherapy in the first line treatment of patients with T –cell Lymphoma. This will be assessed using end of treatment PET scan.	—

Measure

Time frame

Main Objective: To compare the efficacy of the GEM-P chemotherapy regimen with CHOP chemotherapy in the first-line treatment of T-cell lymphoma.;Secondary Objective: To investigate between both arms: • Rate of metabolic complete response and partial response • Best achieved response rate by CT • Toxicity of treatment • Overall survival (OS) • Progression Free Survival (PFS);Primary end point(s): To compare the metabolic complete response rate of GEM-P with CHOP chemotherapy in the first line treatment of patients with T –cell Lymphoma. This will be assessed using end of treatment PET scan.

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Secondary

Measure	Time frame
Secondary end point(s): To investigate between both arms: • Rate of metabolic complete response and partial response • Best achieved response rate by CT • Toxicity of treatment • Overall survival (OS) • Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: All patients will be monitored during treatment for assessment of treatment related toxicity. Determination of PET metabolic reponse will be undertaken on post treatment scan. After completion of treatment, patients will be followed up for a period of five years to evaluate the secondary endpoints of progression-free and overall survival.	—

Measure

Time frame

Secondary end point(s): To investigate between both arms: • Rate of metabolic complete response and partial response • Best achieved response rate by CT • Toxicity of treatment • Overall survival (OS) • Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: All patients will be monitored during treatment for assessment of treatment related toxicity. Determination of PET metabolic reponse will be undertaken on post treatment scan. After completion of treatment, patients will be followed up for a period of five years to evaluate the secondary endpoints of progression-free and overall survival.

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Countries

United Kingdom

Contacts

Public ContactJoanne Culver CTC

The Royal Marsden NHS FOundation Trust

joanne.culver@rmh.nhs.uk02086613807

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 6, 2026