Know Cancer

forgot password

CHEMO-T: 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

Phase 2
18 Years
Open (Enrolling)
Peripheral T-cell Lymphoma NOS, Anaplastic Large Cell Lymphoma, ALK-Negative, Angioimmunoblastic T-cell Lymphoma, Hepatosplenic Gamma/ Delta T-cell Lymphoma

Thank you

Trial Information

CHEMO-T: 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

Background: T-cell lymphoma is an aggressive rare subset of Non-Hodgkin lymphoma (NHL)
comprising several different subtypes of disease within this group. No standard first-line
treatment exists for T-cell lymphoma as published series are small, with heterogeneous
populations and often retrospective.

PROTOCOL SYNOPSIS Study Period: 5 years



• To compare the complete response rate of GEM-P with CHOP chemotherapy in the first line
treatment of patients with T - cell Lymphoma. Secondary

To investigate, between both arms:

- Rate of metabolic complete response

- Toxicity of treatment

- Overall survival (OS)

- Progression Free Survival (PFS) Exploratory

- Investigate impact of International Prognostic Index(IPI) on the outcomes response
rate, PFS and OS Study Design: A randomised multi-centre open-label phase II study
Indication: Previously untreated T-Cell lymphoma No of Participants: 186 (93 patients
in each arm) Main Eligibility Criteria

- Histologically proven T-cell lymphoma of the following subtypes:

- Peripheral T-cell lymphoma NOS

- Systemic Anaplastic large cell lymphoma (ALCL) Anaplastic lymphoma kinase (ALK)negative
cases only

- Angioimmunoblastic T-cell lymphoma

- Hepatosplenic gamma/ delta T-cell lymphoma

- Bulky Stage I, Stage II, III or IV

- No prior chemotherapy regimen

- Patients aged 18 years or over.

- WHO performance status 0,1 or 2

- Adequate organ function:

- No Central Nervous System(CNS) or leptomeningeal involvement with lymphoma

- No treatment for lymphoma within 4 weeks of commencing trial therapy

- No known HIV, Hepatitis C or active Hepatitis B viral infection


CHOP: cyclophosphamide, doxorubicin, vincristine, prednisolone every 21 days. GEM-P:
gemcitabine, methylprednisolone, cisplatin every 28 days.

Assessment Schedule:

- Patients will be reviewed at baseline and prior to each scheduled dose of treatment for

- Radiological tumour assessment will be done with CT scan after every 2 cycles in Arm A
and after cycle 1, 3 and 4 in Arm B

- PET/CT scan will be performed at baseline and upon completion of treatment..

- Follow up after completion of treatment will be 3, 6, 9, 12, 18, 24 months then
annually for 5 years in total. CT scan will be performed at 3 & 12 months.

- Following disease progression patients will be followed for survival every 3 months
until death

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

- 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

- 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 Upper limit of normal (ULN); Alanine
transaminase/Aspartate transaminase (ALT/AST) ≤2.5x ULN; ALP ≤3x ULN (in the absence
of liver metastases). If liver metastases are present, ALT, AST or Alkaline
phosphatase (ALP) ≤5x ULN are permitted. Isolated hyperbilirubinaemia due to
Gilbert's disease is acceptable

- Female patient of childbearing potential must have a negative serum or urine β-human
chorionic gonadotropin(hCG)pregnancy test at baseline.

- Written informed consent must be obtained prior to start of study treatments. Scans
and bone marrow biopsies performed within 4 weeks of commencement of therapy will be
acceptable provided they have been performed according to study requirements.

- Patient agreeable to use contraception for the period of study treatment and up to 12
months after the last dose of study drugs.

Exclusion Criteria:

- Documented or symptomatic central nervous system involvement or leptomeningeal

- Patients with no measurable disease on the contrast enhanced CT scan at baseline.

- Any other clinically significant disease or co-morbidity which may adversely affect
the safe delivery of treatment within this trial.

- Any other malignancies diagnosed or treated within the last 5 years (other than
curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the

- Treatment with another investigational agent within 30 days of commencing study

- Known positive tests for human immunodeficiency virus (HIV) infection, hepatitis C
virus, acute or active hepatitis B infection.

- Patient is pregnant or breastfeeding, or expecting to conceive or father children
within one year of finishing study treatment.

- Patients with poorly controlled diabetes mellitus

- Hypersensitivity or contraindication to any of the study drugs as stated in the
Summaries of product characteristics(SmPCs)for each of the study drugs. Patients with
previous cardiac infarct but satisfactory cardiac function may be allowed at the
discretion of Chief Investigator.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

complete response rate (CR/CRu)

Outcome Time Frame:

approximately 20 weeks after randomisation

Safety Issue:


Principal Investigator

David Cunningham, MD FRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

RMH CCR: 3549



Start Date:

March 2012

Completion Date:

August 2022

Related Keywords:

  • Peripheral T-cell Lymphoma NOS
  • Anaplastic Large Cell Lymphoma, ALK-negative
  • Angioimmunoblastic T-cell Lymphoma
  • Hepatosplenic Gamma/ Delta T-cell Lymphoma
  • T cell lymphoma
  • untreated
  • Immunoblastic Lymphadenopathy
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, Large-Cell, Anaplastic