Lenalidomide in Combination With CHOP in Patients With Untreated PTCL

NCT04423926 | Unknown Phase 1

• 1 other identifier: 2019-SR-429
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

PTCL, NOS; AITL; ALK- ALCL; Phase III-IV ALK+ ALCL; EATL

Keywords

PTCL; lenalidomide; untreated; CHOP

Outcome Measures

Primary Outcomes (2)

• maximum tolerated dose and dose limited toxicity

  At the end of the first cycle of lenalidomide+CHOP (each cycle is 21 days)

• Overall response rate

  overall response rate after treated by lenalidomide-CHOP regimen

  6 months

Secondary Outcomes (2)

• Progressive free survival

  2 years

• Overall survival

  2 years

Study Arms (1)

Lenalidomide+CHOP

EXPERIMENTAL

Drug: Lenalidomide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisolone

Interventions

Lenalidomide DRUG

Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1\~d10# 21days a cycle

Lenalidomide+CHOP

Cyclophosphamide DRUG

Cyclophosphamide 750 mg/m2 d1

Lenalidomide+CHOP

Doxorubicin DRUG

Doxorubicin 50 mg/m2 d1

Lenalidomide+CHOP

Vincristine DRUG

Vincristine 1.4mg/m2 (maximum 2mg) d1

Lenalidomide+CHOP

Prednisolone DRUG

Prednisolone 60mg/m2 d1-5

Lenalidomide+CHOP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed PTCL, NOS, AITL, ALK- ALCL, phase III-IV ALK+ ALCL, EATL according to WHO 2016 criteria.
• ECOG PS 0-2
• Age 18-70 years old
• Expected survival ≥ 12 weeks
• A measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm)
• Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.
• 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

You may not qualify if:

• Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures
• Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons
• Patients known to have varicella or herpes zoster virus infection
• Previous exposure to any anti-tumor therapy
• 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
• History of DVT or PE within past 12 months
• 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
• 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
• CNS or meningeal involvement
• Known sensitivity or allergy to investigational product
• Major surgery within three weeks
• Patients receiving organ transplantation
• 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
• Presence of Grade III nervous toxicity within past two weeks
• Active and severe infectious diseases

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 24441915 BACKGROUND

• 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.

  PMID: 23731832 BACKGROUND

• 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.

  PMID: 24632715 BACKGROUND

• 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.

  PMID: 27982416 BACKGROUND

MeSH Terms

Conditions

Pyloric Stenosis, Hypertrophic

Interventions

Lenalidomide; Cyclophosphamide; Doxorubicin; Vincristine; Prednisolone

Condition Hierarchy (Ancestors)

Pyloric Stenosis; Gastric Outlet Obstruction; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Wei Xu, M.D., Ph.D.

  The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Wang, M.D., Ph.D.

CONTACT

86 25 68306034; lilyw7878@163.com

Wei Xu, M.D., Ph.D.

CONTACT

86 25 68306034; xuwei10000@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 9, 2020
• Study Start: June 10, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

CN (1)