CHOP vs GEM-P in 1st Line Treatment of T-cell Lymphoma, Multicentre Phase II Study (NCT01719835) | Clinical Trial Compass
UnknownPhase 2
CHOP vs GEM-P in 1st Line Treatment of T-cell Lymphoma, Multicentre Phase II Study
United Kingdom87 participantsStarted 2012-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
* Enteropathy-associated T-cell lymphoma (EATL)
* Bulky stage I not being considered for reduced chemotherapy plus involved field radiotherapy or stage II, III or IV.
* Patient is male or female, and ≥18 years of age on the day of signing informed consent.
* WHO performance status 0, 1 or 2.
* Cross sectional imaging from a baseline contrast enhanced CT should show at least one measurable disease site that is at least 2 cm in longest diameter and measurable in two perpendicular dimensions with or without corresponding Fluorodeoxyglucose(FDG) avid lesions.
* Adequate cardiac function; formal assessment of left ventricular ejection fraction is only required if clinically indicated (a baseline echocardiogram should be done for patients with either hypertension, age \> 60 years or history of cardiac disease)
* Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.0x109/l; white blood cell count ≥ 3x109/l; platelets ≥ 100x109/l; haemoglobin (Hb) ≥ 9g/dl (can be post-transfusion), unless deemed disease related
* Adequate renal function: calculated creatinine clearance ≥50ml/minute.
* Adequate liver function: serum bilirubin ≤1.5x Uppe…
What they're measuring
1
complete response rate (CR/CRu)
Timeframe: approximately 20 weeks after randomisation