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

NCT01719835 | Unknown Phase 2 DMC

• 2 other identifiers: RMH CCR: 35492011-004146-18
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

T-Cell Lymphoma; Untreated

Outcome Measures

Primary Outcomes (1)

• complete response rate (CR/CRu)

  approximately 20 weeks after randomisation

Secondary Outcomes (4)

• Toxicity

  approximately 20 weeks after randomisation

• Overall Survival

  1 and 2 years

• Progression Free survival

  1 and 2 years

• Metabolic Complete Response Rate

  approximately 20 weeks after randomisation

Study Arms (2)

Chemotherapy GEM-P

EXPERIMENTAL

Gemcitabine, Methylprednisolone, Cisplatin

Drug: Gemcitabine; Drug: methylprednisolone; Drug: Cisplatin

Chemotherapy CHOP

ACTIVE COMPARATOR

Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone

Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisolone

Interventions

Cyclophosphamide DRUG

750mg/m2 IV every 21 days

Chemotherapy CHOP

Gemcitabine DRUG

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

Chemotherapy GEM-P

Doxorubicin DRUG

50mg/m2 IV every 21 days

Chemotherapy CHOP

Vincristine DRUG

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

Chemotherapy CHOP

Prednisolone DRUG

100mg PO Days 1-5 every 21 days

Chemotherapy CHOP

methylprednisolone DRUG

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

Chemotherapy GEM-P

Cisplatin DRUG

100mg/m2 IV Day 15 every 28 days

Chemotherapy GEM-P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 β-human chorionic gonadotropin(hCG)pregnancy test at baseline.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Cancer Research UK: collaborator

Study Sites (1)

Royal Marsden NHS Foundation Trust - London and Surrey

London, SM2 5PT, United Kingdom

Location

Related Publications (1)

• Gleeson M, Peckitt C, To YM, Edwards L, Oates J, Wotherspoon A, Attygalle AD, Zerizer I, Sharma B, Chua S, Begum R, Chau I, Johnson P, Ardeshna KM, Hawkes EA, Macheta MP, Collins GP, Radford J, Forbes A, Hart A, Montoto S, McKay P, Benstead K, Morley N, Kalakonda N, Hasan Y, Turner D, Cunningham D. CHOP versus GEM-P in previously untreated patients with peripheral T-cell lymphoma (CHEMO-T): a phase 2, multicentre, randomised, open-label trial. Lancet Haematol. 2018 May;5(5):e190-e200. doi: 10.1016/S2352-3026(18)30039-5.

  PMID: 29703335 DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell; Lymphoma, Large-Cell, Anaplastic; Immunoblastic Lymphadenopathy; Enteropathy-Associated T-Cell Lymphoma

Interventions

Cyclophosphamide; Gemcitabine; Doxorubicin; Vincristine; Prednisolone; Methylprednisolone; Cisplatin

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphadenopathy

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• David Cunningham, MD FRCP

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: November 1, 2012
• Study Start: March 1, 2012
• Primary Completion: November 30, 2016
• Study Completion: August 1, 2022
• Last Updated: March 15, 2018

Record last verified: 2018-03

Locations

GB (1)