Clinical trial NCT04423926: Lenalidomide in Combination With CHOP in Patients With Untreated PTCL
Official title: A Phase II, Prospective, Single-center Study of Lenalidomide in Combination With CHOP in Patients With Untreated PTCL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: PTCL, NOS
AITL
ALK- ALCL
Phase III-IV ALK+ ALCL
EATL
Keywords: PTCL
lenalidomide
untreated
CHOP
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: maximum tolerated dose and dose limited toxicity
timeFrame: At the end of the first cycle of lenalidomide+CHOP (each cycle is 21 days)
measure: Overall response rate
timeFrame: 6 months
Secondary outcomes:
measure: Progressive free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
state: Jiangsu
Study officials:
affiliation: The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
name: Wei Xu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hopfinger G, Nosslinger 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.
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.
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.
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.