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Trial record 1 of 57 for:    Romidepsin | Phase 2
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Phase II Study of Gemcitabine+Romidepsin in the Relapsed/Refractory Peripheral T-cell Lymphoma Patients (FIL_GEMRO)

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ClinicalTrials.gov Identifier: NCT01822886
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

Brief Summary:
Pilot clinical trial - Phase 2a, multicenter, single arm, open label trial - to evaluate efficacy and safety of concomitant combination treatment with Gemcitabine and Romidepsin (GEMRO) regimen as salvage treatment in relapsed/refractory PTCL in a selected population of patients.

Condition or disease Intervention/treatment Phase
Peripheral T-cell Lymphoma Drug: Romidepsin, Gemcitabine Phase 2

Detailed Description:
Objectives will be focused on preliminary dose-response, type of patients, frequency of dosing, and safety and tolerability profile.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IIa Study on the Role of Gemcitabine Plus Romidepsin (GEMRO Regimen) in the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma Patients.
Actual Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : July 2018


Arm Intervention/treatment
Experimental: Romidepsin, Gemcitabine
Romidepsin 12 mg/m2 d.1,8, 15 + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD
Drug: Romidepsin, Gemcitabine
Romidepsin 12 mg/m2 d.1,8, 15 for 6 cycles + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD.




Primary Outcome Measures :
  1. CR rate [ Time Frame: 18 months ]
    The proportion of patients with complete remission (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007).


Secondary Outcome Measures :
  1. DOR [ Time Frame: 30 months ]
    Calculated from the date of initial documentation of response, to the date of the first documented evidence of PD (or relapse).

  2. PFS [ Time Frame: 30 months ]
    The time from start of study treatment to first documentation of objective tumor progression or to death due to any cause, whichever comes first. PFS data will be censored on the day following the date of the last radiological assessment of measured lesions documenting absence of progressive disease for patients who do not have objective tumor progression and are still on study at the time of an analysis, are given antitumor treatment other than the study treatment or stem cell transplant, or are removed from study prior to documentation of objective tumor progression. Patients lacking an evaluation of tumor response after their first dose will have their event time censored at 1 day.

  3. OS [ Time Frame: 30 months ]
    OS is measured from the date of study entry to the date of patient's death. If the patient is alive or his vital status is unknown, the date of death will be censored at the date that the patient is last known to be alive.

  4. B-symptoms [ Time Frame: 30 months ]
    B symptom resolution rate is defined as the proportion of patients with lymphoma-related B symptoms at baseline who achieve resolution of all B symptoms at any time during the treatment period.

  5. Safety [ Time Frame: 30 months ]
    Common Terminology Criteria for Adverse Events (CTCAE Version 4.0)

  6. ORR [ Time Frame: 30 months ]
    The proportion of patients who achieve CR, CRu or PR relative to the per-protocol population. Disease response and progression will be evaluated according to the "Revised Response Criteria" for malignant lymphoma (Cheson et al. 2007).



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

Inclusion Criteria:

  • Patients with histological diagnosis of PTCL according to the WHO classification
  • Age ≥ 18 years
  • Relapsed (≥1) or refractory to conventional chemotherapy/radiotherapy
  • Stage I-IV according to the Ann Arbor staging System
  • ECOG Performance status ≤2
  • Normal renal and hepatic functions
  • Laboratory test results as follows:

    • Serum creatinine ≥ 2.0 mg/dL
    • Total bilirubin ≥ 1.5 mg/dL
    • AST (SGOT) and ALT (SGPT) £2 x ULN or £5 x ULN if hepatic metastases are present
    • Negative HIV HCV and HBV status
  • Adequate bone marrow reserve: Platelet count>100X109 cells/L or platelet count <75X109 cells/L if bone marrow disease involvement, absolute neutrophile count (ANC)> 1,5 X109, hemoglobin>8 g/dl.
  • Able to adhere to the study visit schedule and other protocol requirements
  • Cardiac ejection fraction (MUGA scan or echocardiography) > 45%
  • Life expectancy > 6 months
  • Females of childbearing potential (FCBP) must have a negative serum or urine β-hCG pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
  • Both females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days after the last dose of study drug.
  • Measurable disease of at least 2 cm as detected by CT scan, assessed by site radiologist
  • Patients or they legally authorized representative must provide written informed consent

Exclusion Criteria:

  • Any serious active disease or co-morbid medical condition (according to investigator's decision)
  • Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 3 years
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
  • Patients with congenital long QT syndrome, history of significant cardiovascular disease and/or taking drugs leading to significant QT prolongation
  • Corrected QT interval > 480 msec (using the Fredericia formula)
  • Low K+ (<3.8 mmol/L) and low Mg+ (<0.85 mmol/L) levels, except if corrected before beginning the chemotherapy
  • Pregnant or lactating females or men or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study
  • Previous exposure to romidepsin or gemcitabine
  • CNS disease (meningeal and/or brain involvement by lymphoma) or testicular involvement
  • History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
  • Active opportunistic infection

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): NCT01822886


Locations
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Italy
A.O. SS. Antonio e Biagio e C. Arrigo
Alessandria, Italy, 15121
Istituto di Ematologia ed Oncologia Medica A. Seragnoli Policlinico S. Orsola
Bologna, Italy, 40138
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Italy, 20133
A.O. Universitaria Citta' Della Salute E Della Scienza Di Torino
Torino, Italy, 10126
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Investigators
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Principal Investigator: Pier Luigi Zinzani Istituto Ematologia e Oncologia Medica "SERAGNOLI" Università di Bologna - BOLOGNA

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT01822886     History of Changes
Other Study ID Numbers: FIL_GEMRO
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Keywords provided by Fondazione Italiana Linfomi ONLUS:
T-cell lymphoma
Romidepsin

Additional relevant MeSH terms:
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Romidepsin
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic