Extranodal NK-T-Cell Lymphoma, Nasal TypeNCT02764281
MEDA Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation for Stage IV Natural Killer/T-cell Lymphoma
A study testing MEDA and Auto-HSCT in people with Extranodal NK-T-Cell Lymphoma, Nasal Type, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 7 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of methotrexate, etoposide, pegaspargase and dexamethasone (MEDA) chemotherapy and autologous hematopoietic stem cell transplantation (Auto-HSCT) in patients with stage IV extranodal natural killer/T-cell lymphoma, nasal type. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Extranodal NK-T-Cell Lymphoma, Nasal Type
- What is being tested?
- MEDA and Auto-HSCT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 7 sitesChina
- Study dates
- Apr 2015to Feb 2020
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type based on WHO 2008 classification of tumors of haematopoietic and lymphoid tissue.
- Eastern Cooperative Oncology Group (ECOG ) performance status 0~3.
- Stage IV disease with at least one measurable lesion.
- Preserved organ functions for: Platelet>50×109/L, hemoglobin>80g/L, total bilirubin (TBIL)<3×ULN, alanine transaminase (ALT)<5×ULN, serum creatinine (Cr)<1.5×ULN, fibrinogen≥0.5g/L, LVEF≥50%.
- Signed Informed consented.
Who cannot join
- Relapsed or progressive disease to prior L-asparaginase-based chemotherapy.
- Concurrent cancers need surgery or chemotherapy within 6 months.
- History of chemotherapy or radiotherapy for other solid cancers within 3 years.
- Recent history of radiotherapy of upper-aero-digestive tract within last 3 months.
- Significant complications: LVEF≤50%, coagulopathy, autoimmune disease, severe infection, or liver cirrhosis, severe hemophagocytic lymphohistiocytosis.
- Mental disorders.
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- Pregnant or lactation.
- HIV, hepatitis virus C (HCV), or active hepatitis virus B (HBV) infection with HBV DNA≥105 copies/ml.
- History of pancreatitis.
- Known history for grade 3/4 allergy to the drugs in chemotherapy regimen.
- Enrolled in other trial treatment.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, 200011
Shanghai Eye Ear Nose and Throat Hospital, Fudan University
Shanghai, Shanghai Municipality, 200031
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Xinhua Hospital
Shanghai, Shanghai Municipality, 200092
Shanghai Dong Fang hospital
Shanghai, Shanghai Municipality, 200120
Shanghai Tong Ren Hospital
Shanghai, Shanghai Municipality, 200336
Xin Jiang People's Hospital
Ürümqi, Xinjiang, 830001
About this study
Official title: The Efficacy and Safety of Methotrexate, Etoposide, Dexamethasone and Pegaspargase Chemotherapy (MEDA) With Autologous HSCT in the Treatment of Stage IV Natural Killer/T-Cell Lymphoma: A Multicenter, Prospective Study
The purpose of this study is to evaluate the efficacy and safety of methotrexate, etoposide, pegaspargase and dexamethasone (MEDA) chemotherapy and autologous hematopoietic stem cell transplantation (Auto-HSCT) in patients with stage IV extranodal natural killer/T-cell lymphoma, nasal type.
Read the detailed description
Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. L-asparaginase based chemotherapy improved overall response and prolonged the long-term survival for patients with stage IV. But the optimal treatment schedule has not been established. This study is designed with four cycles MEDA chemotherapy, followed by Auto-HSCT for stage IV patients with newly onset, relapsed or refractory diseases. The efficacy and safety of this protocol in the treatment of will be measured.
- Being tested
- MEDA, Auto-HSCT
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDADrug
Also called Methotrexate, Etoposide,Dexamethasone,Pegaspargase
Methotrexate, 3.0g/m2/d iv, day 1
Etoposide, 100mg/m2 iv, day 2 to day 4
Dexamethasone, 40mg/d iv, day 1 to day 4
Pegaspargase, 2500IU/m2/d im, day 4
The MEDA chemotherapy will be repeated every 3 weeks.
Auto-HSCTProcedure or surgery
Auto-HSCT will be performed with patients who responded to the initial MEDA chemotherapy with standard BEAM conditioning regimen.
| Study group | Role | What they receive |
|---|---|---|
| MEDA/Auto-HSCT | Experimental | Patients will be initially treated with four cycles MEDA chemotherapy, followed by autologous hematopoietic stem cell transplantation (Auto-HSCT). Receives: Drug: MEDA; Procedure: Auto-HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
The complete response rate will be assessed on day 28 of the 4th course of MEDA chemotherapy.
Measured: Day 28 of the 4th course of MEDA chemotherapy
Secondary outcomes (4)
Progression free survival
Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
Measured: 2-year
Overall response rate
The overall response rate will be assessed on day 28 of the 4th course of MEDA chemotherapy.
Measured: Day 28 of the 4th course of MEDA chemotherapy
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
Measured: Day 1 of each course of chemotherapy and then every 3 months for 2 years
Overall survival
Overall survival is defiend as the time from entry onto the treatment until death of any reason
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 posted6 May 2016 (estimated)
- Study startApr 2015
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK-T-Cell Lymphoma, Nasal TypeStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Tao, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Rong Tao, MD, Study chair, Xinhua hospital, Shanghai Jiao Tong University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764281
- Sponsor's protocol ID
- XHLSG-NK-1602
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2016
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Methotrexate, Etoposide, Dexamethasone and Pegaspargase Chemotherapy (MEDA) With Autologous HSCT in the Treatment of Stage IV Natural Killer/T-Cell Lymphoma: A Multicenter, Prospective Study
- ClinicalTrials.gov ID
- NCT02764281
- Acronym / sponsor ID
- XHLSG-NK-1602
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 6 May 2016 (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.
The purpose of this study is to evaluate the efficacy and safety of methotrexate, etoposide, pegaspargase and dexamethasone (MEDA) chemotherapy and autologous hematopoietic stem cell transplantation (Auto-HSCT) in patients with stage IV extranodal natural killer/T-cell lymphoma, nasal type.
Detailed description
Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. L-asparaginase based chemotherapy improved overall response and prolonged the long-term survival for patients with stage IV. But the optimal treatment schedule has not been established. This study is designed with four cycles MEDA chemotherapy, followed by Auto-HSCT for stage IV patients with newly onset, relapsed or refractory diseases. The efficacy and safety of this protocol in the treatment of will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEDA/Auto-HSCT | Experimental | Drug: MEDA, Procedure: Auto-HSCTPatients will be initially treated with four cycles MEDA chemotherapy, followed by autologous hematopoietic stem cell transplantation (Auto-HSCT). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type based on WHO 2008 classification of tumors of haematopoietic and lymphoid tissue.
- Eastern Cooperative Oncology Group (ECOG ) performance status 0~3.
- Stage IV disease with at least one measurable lesion.
- Preserved organ functions for: Platelet>50×109/L, hemoglobin>80g/L, total bilirubin (TBIL)<3×ULN, alanine transaminase (ALT)<5×ULN, serum creatinine (Cr)<1.5×ULN, fibrinogen≥0.5g/L, LVEF≥50%.
- Signed Informed consented.
Key exclusion criteria (11 listed)
- Relapsed or progressive disease to prior L-asparaginase-based chemotherapy.
- Concurrent cancers need surgery or chemotherapy within 6 months.
- History of chemotherapy or radiotherapy for other solid cancers within 3 years.
- Recent history of radiotherapy of upper-aero-digestive tract within last 3 months.
- Significant complications: LVEF≤50%, coagulopathy, autoimmune disease, severe infection, or liver cirrhosis, severe hemophagocytic lymphohistiocytosis.
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 |
|---|---|---|
| MEDAAlso: Methotrexate, Etoposide,Dexamethasone,PegaspargaseMethotrexate, 3.0g/m2/d iv, day 1 Etoposide, 100mg/m2 iv, day 2 to day 4 Dexamethasone, 40mg/d iv, day 1 to day 4 Pegaspargase, 2500IU/m2/d im, day 4 The MEDA chemotherapy will be repeated every 3 weeks. | Drug | MEDA/Auto-HSCT |
| Auto-HSCTAuto-HSCT will be performed with patients who responded to the initial MEDA chemotherapy with standard BEAM conditioning regimen. | Procedure or surgery | MEDA/Auto-HSCT |
Primary outcome
Complete response rate
Time frame: Day 28 of the 4th course of MEDA chemotherapy
The complete response rate will be assessed on day 28 of the 4th course of MEDA chemotherapy.
4 secondary outcomes
Progression free survival
Time frame: 2-year
Overall response rate
Time frame: Day 28 of the 4th course of MEDA chemotherapy
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: Day 1 of each course of chemotherapy and then every 3 months for 2 years
Overall survival
Time frame: 2-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Rong Tao, MD study chair
Xinhua hospital, Shanghai Jiao Tong University of Medicine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEDA and Auto-HSCT in people with Extranodal NK-T-Cell Lymphoma, Nasal Type, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 7 sites 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Day 28 of the 4th course of MEDA chemotherapy). 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 27 Apr 2020.