AITL Clinical Trial
Official title:
A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With CHOP in Patients With Untreated PTCL
The prognosis of PTCL (except early stage ALK+ ALCL) is dismal. Previous study showed that single agent lenalidomide showed promising therapeutic activity in patients with relapsed or refractory PTCL. The investigators therefore design this phase II study to investigate the safety and efficacy of lenalidomide in combination with CHOP in patients with treatment-naive PTCL.
| Status | Recruiting |
| Enrollment | 91 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | December 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: 1. Histologically confirmed PTCL, NOS, AITL, ALK- ALCL, phase III-IV ALK+ ALCL, EATL according to WHO 2016 criteria. 2. ECOG PS 0-2 3. Age 18-70 years old 4. Expected survival = 12 weeks 5. A measurable or evaluable disease at the time of enrolment (diameter =1.5cm) 6. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements. 7. Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during the trial measures Exclusion Criteria: 1. Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures 2. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons 3. Patients known to have varicella or herpes zoster virus infection 4. Previous exposure to any anti-tumor therapy 5. Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level,Ccr# 50 mL/min unless these abnormalities were related to the lymphoma 6. History of DVT or PE within past 12 months 7. Poor bone-marrow reserve, defined as neutrophil count less than 1.5×109/L or platelet count less than 75×109/L, unless caused by bone marrow infiltration 8. New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome#acute heart failure#severe ventricular arrhythmia 9. CNS or meningeal involvement 10. Known sensitivity or allergy to investigational product 11. Major surgery within three weeks 12. Patients receiving organ transplantation 13. Patients with secondary tumour, excluding cured (5 years without relapse) in situ Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, Gastrointestinal intramucous carcinoma and breast cancer 14. Presence of Grade III nervous toxicity within past two weeks 15. Active and severe infectious diseases 16. Any potential drug abuse, medical, psychological or social conditions whichmay disturb this investigation and assessment 17. In any conditions which investigator considered ineligible for this study. |
| Country | Name | City | State |
|---|---|---|---|
| China | The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital) | Nanjing | Jiangsu |
| Lead Sponsor | Collaborator |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University |
China,
Hopfinger G, Nösslinger T, Lang A, Linkesch W, Melchardt T, Weiss L, Egle A, Greil R. Lenalidomide in combination with vorinostat and dexamethasone for the treatment of relapsed/refractory peripheral T cell lymphoma (PTCL): report of a phase I/II trial. Ann Hematol. 2014 Mar;93(3):459-62. doi: 10.1007/s00277-014-2009-0. Epub 2014 Jan 18. — View Citation
Iqbal J, Wright G, Wang C, Rosenwald A, Gascoyne RD, Weisenburger DD, Greiner TC, Smith L, Guo S, Wilcox RA, Teh BT, Lim ST, Tan SY, Rimsza LM, Jaffe ES, Campo E, Martinez A, Delabie J, Braziel RM, Cook JR, Tubbs RR, Ott G, Geissinger E, Gaulard P, Piccaluga PP, Pileri SA, Au WY, Nakamura S, Seto M, Berger F, de Leval L, Connors JM, Armitage J, Vose J, Chan WC, Staudt LM; Lymphoma Leukemia Molecular Profiling Project and the International Peripheral T-cell Lymphoma Project. Gene expression signatures delineate biological and prognostic subgroups in peripheral T-cell lymphoma. Blood. 2014 May 8;123(19):2915-23. doi: 10.1182/blood-2013-11-536359. Epub 2014 Mar 14. — View Citation
Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, Glaisner S, Gabarre J, Bosly A, Lister J, Li J, Coiffier B. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: the EXPECT trial. Eur J Cancer. 2013 Sep;49(13):2869-76. doi: 10.1016/j.ejca.2013.04.029. Epub 2013 May 31. — View Citation
Schmitz N, de Leval L. How I manage peripheral T-cell lymphoma, not otherwise specified and angioimmunoblastic T-cell lymphoma: current practice and a glimpse into the future. Br J Haematol. 2017 Mar;176(6):851-866. doi: 10.1111/bjh.14473. Epub 2016 Dec 16. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | maximum tolerated dose and dose limited toxicity | At the end of the first cycle of lenalidomide+CHOP (each cycle is 21 days) | ||
| Primary | Overall response rate | overall response rate after treated by lenalidomide-CHOP regimen | 6 months | |
| Secondary | Progressive free survival | from date of inclusion to date of progression, relapse, or death from any cause | 2 years | |
| Secondary | Overall survival | from the date of inclusion to date of death, irrespective of cause | 2 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT04021082 -
CELTIC-1: A Phase 2B Study of Cerdulatinib in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
|
Phase 2/Phase 3 |