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Trial record 55 of 57 for:    Romidepsin | Phase 2

Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas (FIL_PTCL13)

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ClinicalTrials.gov Identifier: NCT02223208
Recruitment Status : Recruiting
First Posted : August 22, 2014
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

Brief Summary:

This is a multicenter study that includes two phases:

  1. A phase I study to define the maximum tolerated dose (MTD) of Romidepsin in addition to CHOEP-21 and to test the safety and feasibility of CHOEP-21 in combination with dose escalation of Romidepsin (8, 10, 12, 14 mg). The dose level defined as MTD of Romidepsin will be used for the subsequent phase II study.
  2. A phase II study to evaluate the efficacy (response rate, progression free survival and overall survival) and safety of Ro-CHOEP-21 incorporated into a treatment strategy including SCT.

Condition or disease Intervention/treatment Phase
Peripheral T-cell Lymphomas (PTCL) PTCL-NOS Angioimmunoblastic T-cell Lymphoma (AITL) ALK- Anaplastic Large Cell Lymphoma (ALCL) Drug: Ro-CHOEP-21 (PHASE I) Drug: Ro-CHOEP-21 (PHASE II) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Romidepsin in Combination With CHOEP as First Line Treatment Before Hematopoietic Stem Cell Transplantation in Young Patients With Nodal Peripheral T-cell Lymphomas: a Phase I-II Study
Actual Study Start Date : September 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : March 2025


Arm Intervention/treatment
Experimental: Ro-CHOEP-21
During the Phase I It will administered Romidepsin (dose escalation) and the combination of CHOEP-21. During the Phase II It will administered Romidepsin (dose according to phase I) and the combination of CHOEP-21.
Drug: Ro-CHOEP-21 (PHASE I)

Romidepsin (dose escalation) Starting dose: 12mg/ms iv day +1 and +8

Dose modification according to toxicity:

  • 14mg/ms day +1 and +8
  • 10mg/ms day +1 and +8
  • 8mg/ms day +1 and +8

CHOEP-21

  • Doxorubicin 50 mg/ms iv day +1,
  • Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1,
  • Cyclophosphamide 750 mg/ms iv day +1,
  • Etoposide 100mg/ms iv from day +1 to +3
  • Prednisone100 mg orally from days +1 to +5

PR or CR:Ro-CHOEP-21 for 3 additional cycles followed by stem cell mobilization and transplantation phase (CR --> AUTO-SCT, PR --> ALLO-SCT)

Other Names:
  • Romidepsin
  • Cyclophosphamide
  • Doxorubicin
  • Vincristin
  • Etoposide
  • Prednisone

Drug: Ro-CHOEP-21 (PHASE II)

Ro-CHOEP-21 x 3 cycles

  • Romidepsin dose according to phase I iv day +1 and +8
  • Doxorubicin 50 mg/ms iv day +1,
  • Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1,
  • Cyclophosphamide 750 mg/ms iv day +1,
  • Etoposide 100mg/ms iv from day +1 to +3
  • Prednisone100 mg orally from days +1 to +5

PR or CR: Ro-CHOEP-21 for 3 additional cycles followed by stem cell mobilization and transplantation phase (CR --> AUTO-SCT, PR --> ALLO-SCT)

Other Names:
  • Romidepsin
  • Cyclophosphamide
  • Doxorubicin
  • Vincristin
  • Etoposide
  • Prednisone




Primary Outcome Measures :
  1. Dose-limiting toxicity (DLT) of Ro-CHOEP-21 (Phase I endpoint) [ Time Frame: 3 months ]
    Incidence of dose-limiting toxicity (DLT) of Ro-CHOEP-21, considering as maximum dose the one causing induction of any grade ≥ 3 non hematologic toxicity or a delay >15 days of planned cycle date observed during the first two cycles according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009)

  2. Progression Free Survival (PFS) of Ro-CHOEP-21 (Phase II endpoint) [ Time Frame: 18 months ]
    PFS on intention to treatment (ITT) evaluated at 18 months. PFS will be defined as the time between the date of enrolment and the date of disease progression, relapse or death from any cause.


Secondary Outcome Measures :
  1. Proportion of patients reaching SCT (Phase I endpoint) [ Time Frame: 6 months ]
    Proportion of patients reaching SCT

  2. ORR = Overall response rate (Phase I endpoint) [ Time Frame: 6 months ]
    Overall response rate (ORR, defined according to the Cheson 2007 response criteria) of the combination of Ro-CHOEP-21.

  3. Overall Response Rate (ORR) and Complete Response (CR)(Phase II endpoint) [ Time Frame: 6 months ]
    ORR and CR (defined according to the Cheson 2007 response criteria), after induction treatment and after SCT.

  4. Event free survival (EFS) (Phase II endpoint) [ Time Frame: 18 months ]
    Event free survival (EFS) defined as the time between the date of enrollment and the date of discontinuation of treatment for any reason

  5. Overall survival (OS) (Phase II endpoint) [ Time Frame: 24 months ]
    Overall survival (OS) defined as the time between the date of enrolment and the date of death from any cause in the ITT population enrolled in the study

  6. Progression Free Survival (PFS) and Overall Survival (OS) (Phase II endpoint) [ Time Frame: 3 months ]
    PFS and OS in patients not responding to the first 3 courses of Ro-CHOEP-21

  7. Toxicities (Phase II endpoint) [ Time Frame: 18 months ]
    Evaluation during the interim analyses of any grade III or higher toxicities, recorded and classified according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009)

  8. Higher toxicities (Phase II endpoint) [ Time Frame: 18 months ]
    Evaluation during all the pretransplant phase of any grade III or higher toxicities, recorded and classified according to the definitions of NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (2009)

  9. Treatment-related mortality (TRM) (Phase II Endpoint) [ Time Frame: 24 months ]
    Treatment-related mortality defined as any death that was not attributable to the lymphoma.

  10. Graft-versus-host disease (GVHD) (Phase II endpoint) [ Time Frame: 24 months ]
    Incidence of acute and chronic GVHD in allografted patients


Other Outcome Measures:
  1. Evaluation of response biomarkers (eg TET2 mutations) [ Time Frame: 8 years ]
    Evaluation of response biomarkers (eg TET2 mutations)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 e ≤ 65 years
  2. Peripheral T-cell lymphomas at diagnosis including: PTCL-NOS, AITL, 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223208


Contacts
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Contact: Uffici Studi FIL 0039 0131033153 segreteria@filinf.it

Locations
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Italy
Ospedale SS. Antonio e Biagio e Cesare Arrigo Recruiting
Alessandria, AL, Italy, 15121
Contact: Manuela Zanni, MD    0039 0131206133    manuela.zanni@ospedale.al.it   
Principal Investigator: Flavia Salvi, MD         
Ospedali Riuniti Umberto I Active, not recruiting
Ancona, AN, Italy, 60126
AOU Policlinico di Bari Withdrawn
Bari, BA, Italy, 70124
Policlinico S. Orsola Malpighi Recruiting
Bologna, BO, Italy, 40138
Contact: Vittorio Stefoni, MD    0039 0516364042    vittorio.stefoni2@unibo.it   
Principal Investigator: Vittorio Stefoni, MD         
Spedali Civili Recruiting
Brescia, BS, Italy, 26123
Contact: Alessandro Re, MD    0039 0303995438    ematologia@spedalicivili.it   
Principal Investigator: Alessandro Re, MD         
Ospedale Businco Recruiting
Cagliari, CA, Italy, 09121
Contact: Giuseppina Cabras, MD    0039 0706095171    cabras.giuseppina@tiscali.it   
Principal Investigator: Giuseppina Cabras, MD         
Fondazione di Ricerca e Cura "Giovanni Paolo II" Not yet recruiting
Campobasso, CB, Italy, 86100
Contact: Sergio Storti, MD    0039 0874312317    sstorti@rm.unicatt.it   
Principal Investigator: Sergio Storti, MD         
Azienda Ospedaliera S.Croce e Carle Recruiting
Cuneo, CN, Italy, 12100
Contact: Claudia Castellino, MD    0039 0171641070    castellino.c@ospedale.cuneo.it   
Principal Investigator: Claudia Castellino, MD         
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Sede di Meldola Not yet recruiting
Meldola, FC, Italy, 47014
Contact: Gerardo Musuraca, MD    0039 0543739280    g.musuraca@irst.em.it   
Principal Investigator: Gerardo Musuraca, MD         
IRCCS Casa Sollievo Della Sofferenza Not yet recruiting
San Giovanni Rotondo, FG, Italy, 71013
Contact: Nicola Cascavilla, MD    0039 0882410566    ematologia@operapadrepio.it   
Principal Investigator: Nicola Cascavilla, MD         
IRCCS AOU San Martino - Clinica Ematologica Not yet recruiting
Genova, GE, Italy, 16321
Contact: Filippo Ballerini, PROF    0039 0105554336    ballerini@unige.it   
Principal Investigator: Filippo Ballerini, PROF         
IRCCS AOU San Martino - UO Ematologia 1 Recruiting
Genova, GE, Italy, 16321
Contact: Angela Giovanna Congiu, MD    0039 0105513731    angelagiovanna.congiu@hsanmartino.it   
Principal Investigator: Angela Giovanna Congiu, MD         
Istituto Clinico Humanitas Terminated
Rozzano, Milano, Italy, 20089
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Recruiting
Milano, MI, Italy, 20122
Contact: Luca Baldini, MD    0039 02 55033334    luca.baldini@unimi.it   
Principal Investigator: Luca Baldini, PROF         
Fondazione IRCCS "Istituto Nazionale dei Tumori" Recruiting
Milano, MI, Italy, 20133
Contact: Paolo Corradini, PROF    0039 0223902950    paolo.corradini@unimi.it   
Principal Investigator: Paolo Corradini, PROF         
Azienda Ospedaliera Ospedale Niguarda Ca' Granda Recruiting
Milano, MI, Italy, 20162
Contact: Chiara Rusconi, MD    0039 02 64447597    chiara.rusconi@ospedaleniguarda.it   
Principal Investigator: Chiara Rusconi, MD         
AO Ospedali Riuniti Villa Sofia - Cervello (Presidio Cervello) Not yet recruiting
Palermo, PA, Italy, 90146
Contact: Caterina Patti, MD    0039 0917803162    kpatti@ospedaliriunitipalermo.it   
Principal Investigator: Caterina Patti, MD         
P.O. di Pescara-Ospedale Civile Spirito Santo Not yet recruiting
Pescara, PE, Italy, 65126
Contact: Francesco Angrilli, MD    0039 0854252838    f.angrilli@virgilio.it   
Principal Investigator: Francesco Angrilli, MD         
IRCCS Centro di Riferimento Oncologico (CRO) Recruiting
Aviano, PN, Italy, 33081
Contact: Michele Spina, MD    0039 043459730    mspina@cro.it   
Principal Investigator: Michele Spina, MD         
AOU di Parma Recruiting
Parma, PR, Italy, 43100
Contact: Francesca Re, MD    0039 0521 703962    fre@ao.pr.it   
Principal Investigator: Francesca Re, MD         
Fondazione IRCCS - Policlinico San Matteo Recruiting
Pavia, PV, Italy, 27100
Contact: Luca Arcaini, MD    0039 0382501381    luca.arcaini@unipv.it   
Principal Investigator: Luca Arcaini, MD         
IRCCS Centro di Riferimento Oncologico della Basilicata (CROB) Not yet recruiting
Rionero in Vulture, PZ, Italy, 85028
Contact: Roberto Guariglia, MD    0039 0972726225    robertoguariglia@libero.it   
Principal Investigator: Roberto Guariglia, MD         
A.O. Bianchi - Melacrino - Morelli Not yet recruiting
Reggio Calabria, RC, Italy, 89125
Contact: Caterina Stelitano, MD    0039 0965397653    cstelit@libero.it   
Principal Investigator: Caterina Stelitano, MD         
IRCCS Arcispedale "Santa Maria Nuova" Recruiting
Reggio Emilia, RE, Italy, 42123
Contact: Francesco Merli, MD    0039 0522296618    merli.francesco@asmn.re.it   
Principal Investigator: Francesco Merli, MD         
Università di Roma "La Sapienza" Active, not recruiting
Roma, RM, Italy, 00161
Università Cattolica del Sacro Cuore - Policlinico "A. Gemelli" Withdrawn
Roma, RM, Italy, 00168
Ospedale degli Infermi Recruiting
Rimini, RN, Italy, 47900
Contact: Annalia Molinari, MD    0039 0541705423    annalia.molinari@auslrn.net   
Principal Investigator: Annalia Molinari, MD         
AO Città della Salute e della Scienza - Ematologia 1U Recruiting
Torino, TO, Italy, 10126
Contact: Federica Cavallo, MD    0039 0116334198    f.cavallo@unito.it   
Principal Investigator: Federica Cavallo, MD         
AO Città della Salute e della Scienza - SC Ematologia Recruiting
Torino, TO, Italy, 10126
Contact: Annalisa Chiappella, MD    0039 0116336751    achiappella@cittadellasalute.to.it   
Principal Investigator: Annalisa Chiappella, MD         
AOU "Santa Maria della Misericordia" Recruiting
Udine, UD, Italy, 33100
Contact: Stefano Volpetti, MD    0039 0432559784    stefano.volpetti@asuiud.sanita.fvg.it   
Principal Investigator: Stefano Volpetti, MD         
Ospedale Borgo Roma Not yet recruiting
Verona, VR, Italy, 37134
Contact: Fabio Benedetti, MD    0039 045 8124647    fabio.benedetti@univr.it   
Principal Investigator: Fabio Benedetti, MD         
Azienda Ospedaliero-Universitaria Careggi Withdrawn
Firenze, Italy, 50134
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale Recruiting
Napoli, Italy, 80131
Contact: Antonio Pinto, MD    0039 0815903381    a.pinto@istitutotumori.na.it   
Principal Investigator: Antonio Pinto, MD         
Università del Piemonte Orientale - SCDU Ematologia Recruiting
Novara, Italy, 28100
Contact: Gianluca Gaidano, PROF    0039 03213732194    gaidano@med.unipmn.it   
Principal Investigator: Gianluca Gaidano, MD         
A.O. di Perugia - Santa Maria della Misericordia Active, not recruiting
Perugia, Italy, 06132
Ospedale G. Da Saliceto - AUSL di Piacenza Active, not recruiting
Piacenza, Italy, 29121
UO Ematologia Ospedale S.Maria delle Croci Recruiting
Ravenna, Italy, 48121
Contact: Monica Tani, MD    0039 0544286223    monica.tani@auslromagna.it   
Principal Investigator: Monica Tani, MD         
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Investigators
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Principal Investigator: Paolo Corradini, Prof Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

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Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT02223208     History of Changes
Other Study ID Numbers: FIL_PTCL13
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

Keywords provided by Fondazione Italiana Linfomi ONLUS:
PTCL
PTCL-NOS
AITL
ALCL

Additional relevant MeSH terms:
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Romidepsin
Lymphoma
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphoma, T-Cell, Peripheral
Immunoblastic Lymphadenopathy
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphadenopathy
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Etoposide
Etoposide phosphate
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists