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

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ClinicalTrials.gov Identifier: NCT01719835
Recruitment Status : Active, not recruiting
First Posted : November 1, 2012
Last Update Posted : March 15, 2018
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
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 Drug: Cyclophosphamide Drug: Gemcitabine Drug: Doxorubicin Drug: Vincristine Drug: Prednisolone Drug: methylprednisolone Drug: Cisplatin Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2012
Actual Primary Completion Date : November 30, 2016
Estimated Study Completion Date : August 2022


Arm Intervention/treatment
Experimental: Chemotherapy GEM-P
Gemcitabine, Methylprednisolone, Cisplatin
Drug: Gemcitabine
1000mg/m2 IV Days 1, 8, 15 every 28 days

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

Drug: Cisplatin
100mg/m2 IV Day 15 every 28 days

Active Comparator: Chemotherapy CHOP
Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone
Drug: Cyclophosphamide
750mg/m2 IV every 21 days

Drug: Doxorubicin
50mg/m2 IV every 21 days

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

Drug: Prednisolone
100mg PO Days 1-5 every 21 days




Primary Outcome Measures :
  1. complete response rate (CR/CRu) [ Time Frame: approximately 20 weeks after randomisation ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: approximately 20 weeks after randomisation ]
    using Common Terminology Criteria for Adverse Events (CTCAE)v4.0

  2. Overall Survival [ Time Frame: 1 and 2 years ]
  3. Progression Free survival [ Time Frame: 1 and 2 years ]
  4. Metabolic Complete Response Rate [ Time Frame: approximately 20 weeks after randomisation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719835


Locations
United Kingdom
Royal Marsden NHS Foundation Trust - London and Surrey
London, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Cancer Research UK
Investigators
Principal Investigator: David Cunningham, MD FRCP Royal Marsden NHS Foundation Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01719835     History of Changes
Other Study ID Numbers: RMH CCR: 3549
2011-004146-18 ( EudraCT Number )
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

Keywords provided by Royal Marsden NHS Foundation Trust:
T-Cell Lymphoma
Untreated

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Peripheral
Immunoblastic Lymphadenopathy
Intestinal Diseases
Enteropathy-Associated T-Cell Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphadenopathy
Gastrointestinal Diseases
Digestive System Diseases
Gemcitabine
Liposomal doxorubicin
Cisplatin
Cyclophosphamide
Doxorubicin
Vincristine
Prednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate