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PTCL, NOSPhase 1/2NCT04423926

Lenalidomide in Combination With CHOP in Patients With Untreated PTCL

A Phase 1/2 study testing Lenalidomide, Cyclophosphamide and Doxorubicin in people with PTCL, NOS and AITL, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
PTCL, NOS, AITL, ALK- ALCL
What is being tested?
Lenalidomide, Cyclophosphamide and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteChina
Study dates
10 Jun 2020to 31 Dec 2024
Phase
Phase 1/2
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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
  • Any potential drug abuse, medical, psychological or social conditions whichmay disturb this investigation and assessment
  • In any conditions which investigator considered ineligible for this study.

Trial locations and contacts

1 site in 1 country.

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

China1 site, 1 recruiting

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

    Nanjing, Jiangsu, 210029

    Li Wang, M.D., Ph.D, 86 25 68306034, lilyw7878@163.com

    Wei Xu, M.D., Ph.D, 86 25 68306034, xuwei10000@hotmail.com

    Recruiting

Other trials in China

About this study

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.

Keywords
PTCL, lenalidomide, untreated, CHOP
Medical subject headings
Pyloric Stenosis, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04423926
Study groupRoleWhat they receive
Lenalidomide+CHOPExperimentalNot described
Receives: Drug: Lenalidomide; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. maximum tolerated dose and dose limited toxicity

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

  2. Overall response rate

    overall response rate after treated by lenalidomide-CHOP regimen

    Measured: 6 months

Secondary outcomes (2)

  1. Progressive free survival

    from date of inclusion to date of progression, relapse, or death from any cause

    Measured: 2 years

  2. Overall survival

    from the date of inclusion to date of death, irrespective of cause

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start10 Jun 2020 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
91 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04423926
Sponsor's protocol ID
2019-SR-429
Status last verified
Jun 2020
First submitted
8 Jun 2020
Last updated
16 Jun 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 24441915

  • 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.

    PubMed 23731832

  • 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.

    PubMed 24632715

  • 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.

    PubMed 27982416

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lenalidomide, Cyclophosphamide and Doxorubicin in people with PTCL, NOS and AITL, run by The First Affiliated Hospital with Nanjing Medical University at 1 site 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 7 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Li Wang, M.D., Ph.D. (86 25 68306034, lilyw7878@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maximum tolerated dose and dose limited toxicity (time frame: At the end of the first cycle of lenalidomide+CHOP (each cycle is 21 days)). The study lists 2 primary outcomes in all. 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 NCT04423926, which also lists 4 linked publications.

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 16 Jun 2020.

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