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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01719835
• Date of registration: 12/04/2012
• Prospective Registration: No
• Primary sponsor: Royal Marsden NHS Foundation Trust
• Public title: CHOP vs GEM-P in 1st Line Treatment of T-cell Lymphoma, Multicentre Phase II Study CHEMO-T
• Scientific title: 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
• Date of first enrolment: March 2012
• Target sample size: 87
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01719835
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: David Cunningham, MD FRCP
• Affiliation: Royal Marsden NHS Foundation Trust

Key inclusion & exclusion criteria

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 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
ß-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
disease.

- 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
cervix).

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

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral T-cell Lymphoma NOS

Enteropathy-Associated T-Cell Lymphoma

Hepatosplenic Gamma/ Delta T-cell Lymphoma

Anaplastic Large Cell Lymphoma, ALK-Negative

Angioimmunoblastic T-cell Lymphoma

Intervention(s)

Drug: Doxorubicin

Drug: Prednisolone

Drug: Gemcitabine

Drug: Cyclophosphamide

Drug: Vincristine

Drug: Cisplatin

Drug: methylprednisolone

Primary Outcome(s)

complete response rate (CR/CRu) [Time Frame: approximately 20 weeks after randomisation]

Secondary Outcome(s)

Metabolic Complete Response Rate [Time Frame: approximately 20 weeks after randomisation]

Toxicity [Time Frame: approximately 20 weeks after randomisation]

Overall Survival [Time Frame: 1 and 2 years]

Progression Free survival [Time Frame: 1 and 2 years]

Secondary ID(s)

2011-004146-18

RMH CCR: 3549

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cancer Research UK