PEG-ASP+Gemox Regimen and Thalidomide for NK/T Lymphoma

Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type Clinical Trial

Official title:

PA-Gemox Regimen Followed by Thalidomide Versus AspaMetDex Regimen in NKTCL Patients：a Randomized, Open-label, Phase 3 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02085655
• Other study ID #: NKT-SYSUCC-2013
• Status: Recruiting
• Phase: Phase 3
• Start date: April 25, 2013
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: Sun Yat-sen University
• Contact: HuiQiang Huang
• Phone: 86-020-87343350
• Email: huanghq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the efficacy and safety of long-acting aspargase (pegylated aspargase, PEG-ASP) combined with gemcitabine and oxaliplatin (PASP -Gemox) treatment in this population.

Description:

Eligibility criteria The eligibility criteria were pathologically confirmed, previously untreated or refractory/relapsed ENKTL as defined by the World Health Organization classification; age≥18 years; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; at least one measurable lesion; adequate haematologic function (haemoglobin > 9.0 g/l, absolute neutrophil count > 1500/ml, platelets > 75,000/l), hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal), renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); normal coagulation function and electrocardiogram results. Prior chemotherapy and radiotherapy should have been completed >4 weeks earlier, willingness to provide written informed consent. Stage was defined according to the Ann Arbor system. The Sun Yat-Sen University Cancer Centre Research Ethics Board approved this study before subjects were enrolled.

Treatment PA-Gemox dosages were as follows: days 1 and 8, 30-min intravenous infusion of 1000 mg/m2 gemcitabine; day 1, 2-h intravenous infusion of 130 mg/m2 oxaliplatin; day 1, deep intramuscular injection of 2500 U/m2 PEG-ASP at two different sites. The regimen was repeated every 3 weeks for a maximum of six cycles. Stage IE/IIE patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got CR, PR or SD. Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved- field radiation (IFRT) dose was 50-56 Gy. Refractory/relapsed patients underwent at least two cycles treatments unless there was disease progression or unacceptable side effects, or withdrawal of patient consent. Autologous haematopoietic stem cell transplantation (AHSCT) was recommended after they achieved CR.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. pathologically confirmed, previously untreated or refractory/relapsed ENKTL as defined by the World Health Organization classification;

2. age=18 years;

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;

4. at least one measurable lesion;

5. adequate haematologic function (haemoglobin > 9.0 g/l, absolute neutrophil count > 1500/ml, platelets > 75,000/l),

6. adequate hepatic function (total serum bilirubin = 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase = 2.5 times the upper limit of normal),

7. adequate renal function (serum creatinine = 1.5 mg/dl, creatinine clearance = 50 ml/min);

8. normal coagulation function and electrocardiogram results.

9. Prior chemotherapy and radiotherapy should have been completed >4 weeks earlier,

10. willingness to provide written informed consent.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Drug:
• pegaspargase
pegaspargase: 2000U/m2 im on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
• Gemcitabine
1000mg/m2, ivd on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
• Oxaliplatin
100mg/m2 ivd on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops
• Methotrexate
3000m g/m2 civ 6-hour on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
• Dexamethasone
40mg ivd on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
• Thalidomide
100-200mg, PO, after chemotherapy

Locations

Country	Name	City	State
China	Department of Medical Oncology, Sun Yat-sen University Cancer Center,	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Huiqiang Huang	Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Efficacy Outcome Measure		Up to 36 months
Primary	Efficacy Outcome Measure	Study group increase 15% 2-year PFS	up to 24 months
Secondary	Safety/Adverse Event Outcome Measure	Number of Participants with Serious and Non-Serious Adverse Events	Up to 36 months