Lymphoma, T-Cell, PeripheralPhase 2NCT02404571
GDP in Frontline Chemotherapy for Patients With PTCL-NOS
A Phase 2 study testing GDP chemotherapy in people with Lymphoma, T-Cell, Peripheral, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is to evaluate the efficacy and safety of GDP (gemcitabine, dexamethasone, and cisplatin) chemotherapy in patients with peripheral T-cell lymphoma-NOS as frontline treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Peripheral
- What is being tested?
- GDP chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2016
- 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
- histological and imaging diagnosis of PTCL-NOS based on immunophenotypic and morphologic criteria according to the 2008 World Health Organization classification of lymphomas;
- newly-diagnosed patients with no prior systemic chemotherapy or stem-cell transplantation treatment.
- age ≥ 18 years;
- life expectancy of more 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- at least one measurable lesion;
- adequate hematologic, hepatic, and renal functions: absolute neutrophil count ≥ 1.5×109/l, platelet count ≥ 100×109/l, total bilirubin ≤ 1.5 × upper limit of normal, AST and ALT ≤ 2 × upper limit of normal, and creatinine ≤ 1.5 mg/dl;
- informed consent.
Who cannot join
- patients who received prior treatment;
- pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception;
- patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
- patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
- other serious illness or medical conditions A. Clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment [NYHA class III or IV], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 AV block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry B. Liver cirrhosis (≥ Child-Pugh class B) C. History of significant neurologic or psychiatric disorders including dementia or seizures D. Active uncontrolled infection E. Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, Beijing Municipality, 100021
Mei Dong, (86)13811929322, dongmei030224@163.com
About this study
Official title: The Efficacy and Toxicity of GDP Chemotherapy in Patients With Peripheral T-cell Lymphoma: An Open-label, Single-arm, Phase II Clinical Trial
This study is to evaluate the efficacy and safety of GDP (gemcitabine, dexamethasone, and cisplatin) chemotherapy in patients with peripheral T-cell lymphoma-NOS as frontline treatment.
Read the detailed description
Peripheral T-cell lymphomas,not otherwise specified constitutes 25.9% of Peripheral T-cell lymphomas and over 15% of all lymphomas by the World Health Organization classification. Because of the rare presentation and evident heterogeneity of PTCL-NOS, optimal frontline therapy for this disease in the modern era remains unclear. Patients have traditionally been treated with anthracycline-containing chemotherapy such as CHOP or CHOP-like regimen used in B-cell NHLs. This strategy is associated with an overall response rate higher than 60%, but the 5-year PFS and OS rates have been reported to be as low as approximately 20-30%.Better therapeutic regimens are in highly need to improve the survival outcome of these patients. The investigators' previous study reported an ORR of 64% in relapsed/refractory PTCL-NOS patients. Therefore, the investigators design this study to evaluate the efficacy and safety of GDP chemotherapy as frontline treatment in patients with PTCL-NOS.
- Conditions
- Lymphoma, T-Cell, Peripheral
- Being tested
- GDP chemotherapy
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDP chemotherapyDrug
gemcitabine (1000mg/m2 intravenously over 30 minutes on days 1 and 8), cisplatin (25mg/m2 intravenously over 60 minutes on days 1-3), and dexamethasone (20mg/d orally on days 1-4 and days 11-14), which was administered every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| GDP chemotherapy | Experimental | GDP chemotherapy: gemcitabine (1000mg/m2 intravenously over 30 minutes on days 1 and 8), cisplatin (25mg/m2 intravenously over 60 minutes on days 1-3), and dexamethasone (20mg/d orally on days 1-4 and days 11-14), which was administered every 21 days. Receives: Drug: GDP chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: 4-6 cycles
Secondary outcomes (3)
2-year progression-free survival
Measured: 2 year
2-year overall survival
Measured: 2 year
number of patients with adverse events
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startJan 2011
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-Cell, PeripheralStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Dong, Chinese Academy of Medical Sciences
- Investigators
- Mei Dong, Principal investigator, Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404571
- Sponsor's protocol ID
- GiFT
- Status last verified
- Jul 2016
- First submitted
- 26 Mar 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Toxicity of GDP Chemotherapy in Patients With Peripheral T-cell Lymphoma: An Open-label, Single-arm, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT02404571
- Acronym / sponsor ID
- GiFT
- Conditions
- Lymphoma, T-Cell, Peripheral
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 31 Mar 2015 (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 study is to evaluate the efficacy and safety of GDP (gemcitabine, dexamethasone, and cisplatin) chemotherapy in patients with peripheral T-cell lymphoma-NOS as frontline treatment.
Detailed description
Peripheral T-cell lymphomas,not otherwise specified constitutes 25.9% of Peripheral T-cell lymphomas and over 15% of all lymphomas by the World Health Organization classification. Because of the rare presentation and evident heterogeneity of PTCL-NOS, optimal frontline therapy for this disease in the modern era remains unclear. Patients have traditionally been treated with anthracycline-containing chemotherapy such as CHOP or CHOP-like regimen used in B-cell NHLs. This strategy is associated with an overall response rate higher than 60%, but the 5-year PFS and OS rates have been reported to be as low as approximately 20-30%.Better therapeutic regimens are in highly need to improve the survival outcome of these patients. The investigators' previous study reported an ORR of 64% in relapsed/refractory PTCL-NOS patients. Therefore, the investigators design this study to evaluate the efficacy and safety of GDP chemotherapy as frontline treatment in patients with PTCL-NOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GDP chemotherapy | Experimental | Drug: GDP chemotherapyGDP chemotherapy: gemcitabine (1000mg/m2 intravenously over 30 minutes on days 1 and 8), cisplatin (25mg/m2 intravenously over 60 minutes on days 1-3), and dexamethasone (20mg/d orally on days 1-4 and days 11-14), which was administered every 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- histological and imaging diagnosis of PTCL-NOS based on immunophenotypic and morphologic criteria according to the 2008 World Health Organization classification of lymphomas;
- newly-diagnosed patients with no prior systemic chemotherapy or stem-cell transplantation treatment.
- age ≥ 18 years;
- life expectancy of more 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
Key exclusion criteria (5 listed)
- patients who received prior treatment;
- pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception;
- patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
- patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
- other serious illness or medical conditions A. Clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment [NYHA class III or IV], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 AV block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry B. Liver cirrhosis (≥ Child-Pugh class B) C. History of significant neurologic or psychiatric disorders including dementia or seizures D. Active uncontrolled infection E. Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
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 |
|---|---|---|
| GDP chemotherapygemcitabine (1000mg/m2 intravenously over 30 minutes on days 1 and 8), cisplatin (25mg/m2 intravenously over 60 minutes on days 1-3), and dexamethasone (20mg/d orally on days 1-4 and days 11-14), which was administered every 21 days. | Drug | GDP chemotherapy |
Primary outcome
overall response rate
Time frame: 4-6 cycles
3 secondary outcomes
2-year progression-free survival
Time frame: 2 year
2-year overall survival
Time frame: 2 year
number of patients with adverse events
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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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.
Mei Dong principal investigator
Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
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 GDP chemotherapy in people with Lymphoma, T-Cell, Peripheral, run by Chinese Academy of Medical Sciences at 1 site in China.
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 8 inclusion and 5 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 26 Jul 2016. 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 China. 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?
Contact Mei Dong ((86)13811929322, dongmei030224@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: 4-6 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2016.