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New drug combo shows promise for rare blood cancer in early trial

NCT ID NCT02223208

Disease control Sponsor: Fondazione Italiana Linfomi - ETS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This study tests adding the drug romidepsin to standard chemotherapy (CHOEP) for young adults (ages 18-65) with a rare type of lymphoma called peripheral T-cell lymphoma. The goal is to see if this combination is safe and effective before patients undergo a stem cell transplant. About 89 participants will be enrolled to find the best dose and measure how long they stay cancer-free.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Romidepsin combined with chemotherapy (cyclophosphamide, doxorubicin, vincristine, etoposide, prednisone)
What this could lead to
If successful, this could lead to a more effective treatment strategy for young patients with peripheral T-cell lymphoma, potentially improving remission rates before stem cell transplant.
What could go wrong
This is an early-phase trial (Phase I/II) with a small number of participants, so results may not apply broadly. The combination may cause significant side effects, and the added benefit of romidepsin is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

89 people

The number who actually took part.

Started

Sep 2014

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 e ≤ 65 years 2. Peripheral T-cell lymphomas at diagnosis including: PTCL-NOS, AITL including other nodal TFH, ALK-ALCL 3. Stage II-IV 4. Written informed consent 5. No prior treatment for lymphoma 6. No Central Nervous System (CNS) disease (meningeal and/or brain involvement by lymphoma) 7. HIV negativity 8. Absence of active hepatitis C virus (HCV) infection 9. HBV negativity or patients with HBcAb +, HBsAg -, HBs Ab+/- with HBV-DNA negativity (in these patients Lamivudine prophylaxis is mandatory) 10. Levels of serum bilirubin, alkaline phosphatase and transaminases \< 2 the upper normal limit, if not disease related 11. No psychiatric illness that precludes understanding concepts of the trial or signing informed consent 12. Ejection fraction \> 50% and myocardial stroke in the last year nor QT prolongation (QTc interval \< 480 msec using the Fridericia formula) 13. Clearance of creatinine \> 60 ml/min if not disease related 14. Spirometry Diffusion Capacity (DLCO) \> 50% 15. Absence of active, uncontrolled infection 16. For males and females of child-bearing potential, agreement upon the use of effective contraceptive methods prior to study entry, for the duration of study participation and in the following 90 days after discontinuation of study treatment 17. Availability of histological material for central review and pathobiological studies. Exclusion Criteria: 1. Age \<18 e \> 65 years 2. Hystology other than: PTCL-NOS, AITL, ALK-ALCL 3. Stage I 4. Prior treatment for lymphoma 5. Positive serologic markers for human immunodeficiency virus (HIV) 6. Active hepatitis B virus (HBV) infection 7. Active hepatitis C virus (HCV) infection 8. Levels of serum bilirubin, alkaline phosphatase and transaminases \> 2 the upper normal limit, if not disease related 9. Ejection fraction \< 50% and no myocardial stroke in the last year or QT prolongation (QTc interval \> 480 msec using the Fridericia formula) 10. Clearance of creatinine \< 60 ml/min if not disease related 11. Spirometry Diffusion Capacity (DLCO) \< 50% 12. Pregnancy or lactation 13. Patient not agreeing to take adequate contraceptive measures during the study 14. Psychiatric disease that precludes understanding concepts of the trial or signing informed consent 15. Any active, uncontrolled infection 16. Prior history of malignancies other than PTCLs in the last five years (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast).

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Conditions

The condition(s) this trial relates to.

ALK-negative anaplastic large cell lymphoma ALK-positive anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma mature T-cell and NK-cell non-Hodgkin lymphoma Nodal T-follicular helper cell lymphoma, follicular type peripheral T-cell lymphoma, not otherwise specified

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALK- anaplastic large cell lymphoma (ALCL) Angioimmunoblastic T-cell lymphoma (AITL) Nodal peripheral T-cell lymphoma of T follicular helper cell origin Peripheral T-cell lymphomas (PTCL) PTCL-nos

Contacts and locations

Locations

  • A.O. di Perugia - Santa Maria della Misericordia

    Perugia, 06132, Italy

  • AO Città della Salute e della Scienza - Ematologia 1U

    Torino, TO, 10126, Italy

  • AO Città della Salute e della Scienza - SC Ematologia

    Torino, TO, 10126, Italy

  • AO Ospedali Riuniti Villa Sofia - Cervello (Presidio Cervello)

    Palermo, PA, 90146, Italy

  • AOU "Santa Maria della Misericordia"

    Udine, UD, 33100, Italy

  • AOU di Parma

    Parma, PR, 43100, Italy

  • Azienda Ospedaliera Ospedale Niguarda Ca' Granda

    Milan, MI, 20162, Italy

  • Azienda Ospedaliera S.Croce e Carle

    Cuneo, CN, 12100, Italy

  • Fondazione IRCCS "Istituto Nazionale dei Tumori"

    Milan, MI, 20133, Italy

  • Fondazione IRCCS - Policlinico San Matteo

    Pavia, PV, 27100, Italy

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, MI, 20122, Italy

  • IRCCS AOU San Martino - Clinica Ematologica

    Genova, GE, 16321, Italy

  • IRCCS AOU San Martino - UO Ematologia 1

    Genova, GE, 16321, Italy

  • IRCCS Arcispedale "Santa Maria Nuova"

    Reggio Emilia, RE, 42123, Italy

  • IRCCS Centro di Riferimento Oncologico (CRO)

    Aviano, PN, 33081, Italy

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089, Italy

  • Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

    Naples, 80131, Italy

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Sede di Meldola

    Meldola, FC, 47014, Italy

  • Ospedale Borgo Roma

    Verona, VR, 37134, Italy

  • Ospedale Businco

    Cagliari, CA, 09121, Italy

  • Ospedale G. Da Saliceto - AUSL di Piacenza

    Piacenza, 29121, Italy

  • Ospedale Maggiore della Carità - SCDU Ematologia

    Novara, 28100, Italy

  • Ospedale SS. Antonio e Biagio e Cesare Arrigo

    Alessandria, AL, 15121, Italy

  • Ospedale degli Infermi

    Rimini, RN, 47900, Italy

  • Policlinico S. Orsola Malpighi

    Bologna, BO, 40138, Italy

  • Spedali Civili

    Brescia, BS, 26123, Italy

  • UO Ematologia Ospedale S.Maria delle Croci

    Ravenna, 48121, Italy

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