Extranodal NK-T-Cell Lymphoma, Nasal TypeNCT02733458
GELAD Chemotherapy and Sandwiched Radiotherapy in the Treatment of Stage IE/IIE Natural Killer/T-cell Lymphoma
A study testing GELAD and Radiotherapy 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 gemcitabine, etoposide, pegaspargase and dexamethasone (GELAD) chemotherapy and sandwiched radiotherapy as first-line treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma, nasal type. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Extranodal NK-T-Cell Lymphoma, Nasal Type
- What is being tested?
- GELAD and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 7 sitesChina
- Study dates
- Mar 2016to Apr 2021
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type, previously untreated
- Eastern Cooperative Oncology Group (ECOG ) performance status 0~3
- Stage IE to IIE disease with at least one measurable lesion in the nasal cavity, paranasal sinuses, orbit, pharynx, Waldeyer's ring, or oral cavity.
- Preserved organ functions for: absolute neutrophil counter (ANC)>1.0×109/L, Platelet>50×109/L, hemoglobin>80g/L, total bilirubin (TBIL)<2×ULN, alanine transaminase (ALT)<2×ULN, serum creatinine<1.5×ULN，fibrinogen≥1.0g/L, LVEF≥50%
- No history of chemotherapy or radiotherapy.
- Signed Informed consented
Who cannot join
- Concurrent cancers need surgery or chemotherapy within 6 months.
- Significant complications: LVEF≤50%, coagulopathy, autoimmune disease, severe infection, or liver cirrhosis, hemophagocytic lymphohistiocytosis.
- Mental disorders.
- 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 Dong Fang hospital
Shanghai, Shanghai Municipality, 200120
Department of Hematology, Renji Hospital
Shanghai, Shanghai Municipality, 201100
South Renji hospital
Shanghai, Shanghai Municipality, 201100
Shanghai Ninth Peoples' Hospital
Shanghai, 200011
Shanghai Eye and ENT Hospital of Fudan University
Shanghai, 200031
Xinhua Hospital
Shanghai
Xin Jiang People's Hospital
Ürümqi, Xinjiang, 830001
About this study
Official title: The Efficacy and Safety of Gemcitabine, Etoposide, Dexamethasone and Pegaspargase Chemotherapy (GELAD) With Sandwiched Radiotherapy in the Treatment of Stage IE/II Natural Killer/T-Cell Lymphoma: A Multicenter, Prospective Study
The purpose of this study is to evaluate the efficacy and safety of gemcitabine, etoposide, pegaspargase and dexamethasone (GELAD) chemotherapy and sandwiched radiotherapy as first-line treatment in patients with de novo stage IE/IIE 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. Radiotherapy alone for stage IE/IIE diseases has good response rate but with high relapse rates, ranging from 20-50%. The combination of chemotherapy and radiotherapy improved the long-term survival for patients with stage IE/IIE diseases. But the optimal treatment schedule has not been established. This study is designed with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with additional two cycles GELAD chemotherapy. The efficacy and safety of this sandwiched chemoradiotherapy in the treatment of stage IE/IIE ENKTCL will be measured.
- Being tested
- GELAD, Radiotherapy
- 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.
GELADDrug
Also called Gemcitabine, Etoposide, Dexamethasone, Pegaspargase
Gemcitabine, 1.0g/m2/d IV, day 1 Etoposide, 60mg/m2 IV, day 1 to day 3 Dexamethasone, 40mg/d IV, day 1 to day 4 Pegaspargase, 2000IU/m2/d IM, day 4
RadiotherapyRadiation
Radiotherapy: 50-56Gy
| Study group | Role | What they receive |
|---|---|---|
| GELAD/Radiation | Experimental | Patients will be initially treated with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with another two cycles GELAD chemotherapy. GELAD chemotherapy will be repeated every 21 days. Radiotherapy will be delivered in 25-32 fractions. Receives: Drug: GELAD; Radiation: Radiotherapy |
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 after the 4th course of chemotherapy.
Measured: 28 days after 4 cycles of 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 complete response rate will be assessed on day 28 after the 4th course of chemotherapy.
Measured: 28 days after 4 cycles of 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 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 posted11 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2021
- Study completionApr 2021
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 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
- 52 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, Principal investigator, Xinhua hospital, Shanghai Jiao Tong University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733458
- Sponsor's protocol ID
- XHLSG-NK-1601
- Status last verified
- Sep 2021
- First submitted
- 5 Apr 2016
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zhu Y, Tian S, Xu L, Ma Y, Zhang W, Wang L, Jin L, Liu C, Zhu C, Li Z, Hao S, Zhong H, Ding H, Tao R. GELAD chemotherapy with sandwiched radiotherapy for patients with newly diagnosed stage IE/IIE natural killer/T-cell lymphoma: a prospective multicentre study. Br J Haematol. 2022 Feb;196(4):939-946. doi: 10.1111/bjh.17960. Epub 2021 Nov 21.
PubMed 34806163
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Gemcitabine, Etoposide, Dexamethasone and Pegaspargase Chemotherapy (GELAD) With Sandwiched Radiotherapy in the Treatment of Stage IE/II Natural Killer/T-Cell Lymphoma: A Multicenter, Prospective Study
- ClinicalTrials.gov ID
- NCT02733458
- Acronym / sponsor ID
- XHLSG-NK-1601
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 11 Apr 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 gemcitabine, etoposide, pegaspargase and dexamethasone (GELAD) chemotherapy and sandwiched radiotherapy as first-line treatment in patients with de novo stage IE/IIE 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. Radiotherapy alone for stage IE/IIE diseases has good response rate but with high relapse rates, ranging from 20-50%. The combination of chemotherapy and radiotherapy improved the long-term survival for patients with stage IE/IIE diseases. But the optimal treatment schedule has not been established. This study is designed with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with additional two cycles GELAD chemotherapy. The efficacy and safety of this sandwiched chemoradiotherapy in the treatment of stage IE/IIE ENKTCL 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 |
|---|---|---|
| GELAD/Radiation | Experimental | Drug: GELAD, Radiation: RadiotherapyPatients will be initially treated with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with another two cycles GELAD chemotherapy. GELAD chemotherapy will be repeated every 21 days. Radiotherapy will be delivered in 25-32 fractions. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type, previously untreated
- Eastern Cooperative Oncology Group (ECOG ) performance status 0~3
- Stage IE to IIE disease with at least one measurable lesion in the nasal cavity, paranasal sinuses, orbit, pharynx, Waldeyer's ring, or oral cavity.
- Preserved organ functions for: absolute neutrophil counter (ANC)>1.0×109/L, Platelet>50×109/L, hemoglobin>80g/L, total bilirubin (TBIL)<2×ULN, alanine transaminase (ALT)<2×ULN, serum creatinine<1.5×ULN，fibrinogen≥1.0g/L, LVEF≥50%
- No history of chemotherapy or radiotherapy.
Key exclusion criteria (8 listed)
- Concurrent cancers need surgery or chemotherapy within 6 months.
- Significant complications: LVEF≤50%, coagulopathy, autoimmune disease, severe infection, or liver cirrhosis, hemophagocytic lymphohistiocytosis.
- Mental disorders.
- Pregnant or lactation
- HIV, hepatitis virus C (HCV), or active hepatitis virus B (HBV) infection with HBV DNA≥105 copies/ml.
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 |
|---|---|---|
| GELADAlso: Gemcitabine, Etoposide, Dexamethasone, PegaspargaseGemcitabine, 1.0g/m2/d IV, day 1 Etoposide, 60mg/m2 IV, day 1 to day 3 Dexamethasone, 40mg/d IV, day 1 to day 4 Pegaspargase, 2000IU/m2/d IM, day 4 | Drug | GELAD/Radiation |
| RadiotherapyRadiotherapy: 50-56Gy | Radiation | GELAD/Radiation |
Primary outcome
Complete response rate
Time frame: 28 days after 4 cycles of chemotherapy
The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.
4 secondary outcomes
Progression free survival
Time frame: 2-year
Overall Response rate
Time frame: 28 days after 4 cycles of chemotherapy
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: Day 1 of each course 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 14 Sep 2021.
- Derived from this study: PubMed 34806163Zhu Y, Tian S, Xu L, Ma Y, Zhang W, Wang L, Jin L, Liu C, Zhu C, Li Z, Hao S, Zhong H, Ding H, Tao R. GELAD chemotherapy with sandwiched radiotherapy for patients with newly diagnosed stage IE/IIE natural killer/T-cell lymphoma: a prospective multicentre study. Br J Haematol. 2022 Feb;196(4):939-946. doi: 10.1111/bjh.17960. Epub 2021 Nov 21.
- Individual participant dataSharing planned: No
Related trials for Extranodal NK-T-Cell Lymphoma, Nasal Type
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Active, not recruitingPhase 2
Study of Pembrolizumab in Patients With Early-Stage NK/T-cell Lymphoma, Nasal Type
NK/T-Cell Lymphoma of Nasal Cavity (Diagnosis), NK/T-Cell Lymphoma of Nasopharynx (Diagnosis)
Active, not recruitingPhase 1/2
A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)
Relapsed or Refractory T-cell Lymphomas
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 principal investigator
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 GELAD and Radiotherapy 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 6 inclusion and 8 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 14 Sep 2021. 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: 28 days after 4 cycles of chemotherapy). 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 NCT02733458, 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 14 Sep 2021.