Peripheral T-cell Lymphoma NOSPhase 2CHEMO-TNCT01719835
CHOP vs GEM-P in 1st Line Treatment of T-cell Lymphoma, Multicentre Phase II Study
A Phase 2 study testing Cyclophosphamide, Gemcitabine and Doxorubicin in people with Peripheral T-cell Lymphoma NOS and Anaplastic Large Cell Lymphoma, ALK-Negative, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-cell Lymphoma NOS, Anaplastic Large Cell Lymphoma, ALK-Negative, Angioimmunoblastic T-cell Lymphoma
- What is being tested?
- Cyclophosphamide, Gemcitabine and Doxorubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Marsden NHS Foundation Trust - London and Surrey
London, SM2 5PT
About this study
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
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.
Read the detailed description
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
Objectives:
Primary:
- 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
- Enteropathy-associated 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, active Hepatitis B or C infection
Treatment:
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 toxicity
- 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
- 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
- Being tested
- Cyclophosphamide, Gemcitabine, Doxorubicin, Vincristine, Prednisolone
- Keywords
- T-Cell Lymphoma, Untreated
- Medical subject headings
- Lymphoma, T-Cell, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Enteropathy-Associated T-Cell Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
750mg/m2 IV every 21 days
GemcitabineDrug
1000mg/m2 IV Days 1, 8, 15 every 28 days
DoxorubicinDrug
50mg/m2 IV every 21 days
VincristineDrug
1.4mg/m2 (max 2mg) IV every 21 days
PrednisoloneDrug
100mg PO Days 1-5 every 21 days
1000mg oral or IV Days 1-5 every 28 days
CisplatinDrug
100mg/m2 IV Day 15 every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy GEM-P | Experimental | Gemcitabine, Methylprednisolone, Cisplatin Receives: Drug: Gemcitabine; Drug: methylprednisolone; Drug: Cisplatin |
| Chemotherapy CHOP | Active comparator | Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone Receives: Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response rate (CR/CRu)
Measured: approximately 20 weeks after randomisation
Secondary outcomes (4)
Toxicity
using Common Terminology Criteria for Adverse Events (CTCAE)v4.0
Measured: approximately 20 weeks after randomisation
Overall Survival
Measured: 1 and 2 years
Progression Free survival
Measured: 1 and 2 years
Metabolic Complete Response Rate
Measured: approximately 20 weeks after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startMar 2012
- Primary completion30 Nov 2016
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral T-cell Lymphoma NOSStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Sponsor
- Investigators
- David Cunningham, MD FRCP, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719835
- Sponsor's protocol ID
- RMH CCR: 3549
- Other IDs
- 2011-004146-18
- Acronym
- CHEMO-T
- Status last verified
- Mar 2018
- First submitted
- 12 Apr 2012
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29703335
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01719835
- Acronym / sponsor ID
- CHEMO-T / RMH CCR: 3549
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- Mar 2012
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- Aug 2022 (estimated)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Objectives:
Primary:
- 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
- Enteropathy-associated 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, active Hepatitis B or C infection
Treatment:
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 toxicity
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy GEM-P | Experimental | Drug: Gemcitabine, Drug: methylprednisolone, Drug: CisplatinGemcitabine, Methylprednisolone, Cisplatin |
| Chemotherapy CHOP | Active comparator | Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: PrednisoloneCyclophosphamide, Doxorubicin, Vincristine, Prednisolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclophosphamide750mg/m2 IV every 21 days | Drug | Chemotherapy CHOP |
| Gemcitabine1000mg/m2 IV Days 1, 8, 15 every 28 days | Drug | Chemotherapy GEM-P |
| Doxorubicin50mg/m2 IV every 21 days | Drug | Chemotherapy CHOP |
| Vincristine1.4mg/m2 (max 2mg) IV every 21 days | Drug | Chemotherapy CHOP |
| Prednisolone100mg PO Days 1-5 every 21 days | Drug | Chemotherapy CHOP |
| methylprednisolone1000mg oral or IV Days 1-5 every 28 days | Drug | Chemotherapy GEM-P |
| Cisplatin100mg/m2 IV Day 15 every 28 days | Drug | Chemotherapy GEM-P |
Primary outcome
complete response rate (CR/CRu)
Time frame: approximately 20 weeks after randomisation
4 secondary outcomes
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
Metabolic Complete Response Rate
Time frame: approximately 20 weeks after randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Derived from this study: PubMed 29703335Gleeson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Cunningham, MD FRCP principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, Gemcitabine and Doxorubicin in people with Peripheral T-cell Lymphoma NOS and Anaplastic Large Cell Lymphoma, ALK-Negative, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response rate (CR/CRu) (time frame: approximately 20 weeks after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01719835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.