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 : Unknown
Verified March 2018 by Royal Marsden NHS Foundation Trust.
Recruitment status was: Active, not recruiting
First Posted : November 1, 2012
Last Update Posted : March 15, 2018
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Condition or disease | Intervention/treatment | Phase |
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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 |
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
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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
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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 |
- complete response rate (CR/CRu) [ Time Frame: approximately 20 weeks after randomisation ]
- Toxicity [ Time Frame: approximately 20 weeks after randomisation ]using Common Terminology Criteria for Adverse Events (CTCAE)v4.0
- Overall Survival [ Time Frame: 1 and 2 years ]
- Progression Free survival [ Time Frame: 1 and 2 years ]
- Metabolic Complete Response Rate [ Time Frame: approximately 20 weeks after randomisation ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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
United Kingdom | |
Royal Marsden NHS Foundation Trust - London and Surrey | |
London, United Kingdom, SM2 5PT |
Principal Investigator: | David Cunningham, MD FRCP | Royal Marsden NHS Foundation Trust |
Responsible Party: | Royal Marsden NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT01719835 |
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 |
T-Cell Lymphoma Untreated |
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoma, Large-Cell, Anaplastic Enteropathy-Associated T-Cell Lymphoma Immunoblastic Lymphadenopathy Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Lymphadenopathy Methylprednisolone |
Prednisolone Cyclophosphamide Gemcitabine Doxorubicin Vincristine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites, Antineoplastic |