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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
Results First Posted : October 10, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

Tracking Information
First Submitted Date  ICMJE March 28, 2013
First Posted Date  ICMJE April 2, 2013
Results First Submitted Date  ICMJE September 12, 2019
Results First Posted Date  ICMJE October 10, 2019
Last Update Posted Date October 14, 2019
Actual Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
Complete Remission (CR) Rate [ Time Frame: 18 months ]
Complete Remission is disappearance of all target lesions per the Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007)"
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2013)
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
  • Percentage of Participants With Progression-Free Survival [ Time Frame: 24 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 (progression-free survival) 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. Percentage of participants is an estimate based on Kaplan-Meier method.
  • Overall Survival is Measured From the Date of Study Entry to the Date of Patient's Death [ Time Frame: 24 months ]
    OS (overall survival) 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.
  • Safety - Frequency of Toxicities Grade 3 and 4 [ Time Frame: 24 months ]
    Frequency of toxicities was reported by type and grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
  • Overall Response Rate (ORR) [ Time Frame: 24 months ]
    ORR the proportion of patients who achieve CR (complete response), CRu (complete remission unconfirmed) or PR (partial response) 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2013)
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • Safety [ Time Frame: 30 months ]
    Common Terminology Criteria for Adverse Events (CTCAE Version 4.0)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of Gemcitabine+Romidepsin in the Relapsed/Refractory Peripheral T-cell Lymphoma Patients
Official Title  ICMJE Phase IIa Study on the Role of Gemcitabine Plus Romidepsin (GEMRO Regimen) in the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma Patients.
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 (peripheral T-cell lymphoma) in a selected population of patients.
Detailed Description Objectives will be focused on preliminary dose-response, type of patients, frequency of dosing, and safety and tolerability profile.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral T-cell Lymphoma
Intervention  ICMJE Drug: Romidepsin + Gemcitabine
Romidepsin 12 mg/m2 day 1,8, 15 + Gemcitabine 800 mg/m2 day 1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 day 1, 15 to PD
Study Arms  ICMJE Experimental: Romidepsin, Gemcitabine
Romidepsin 12 mg/m2 day 1,8, 15 + Gemcitabine 800 mg/m2 day 1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 day 1, 15 to PD (progression disease)
Intervention: Drug: Romidepsin + Gemcitabine
Publications * Pellegrini C, Dodero A, Chiappella A, Monaco F, Degl'Innocenti D, Salvi F, Vitolo U, Argnani L, Corradini P, Zinzani PL; Italian Lymphoma Foundation (Fondazione Italiana Linfomi Onlus, FIL). A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients. J Hematol Oncol. 2016 Apr 12;9:38. doi: 10.1186/s13045-016-0266-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with histological diagnosis of PTCL according to the WHO (World Health Organization) classification
  • Age ≥ 18 years
  • Relapsed (≥1) or refractory to conventional chemotherapy/radiotherapy
  • Stage I-IV according to the Ann Arbor staging System
  • ECOG (Eastern Cooperative Oncology Group) 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 Fridericia 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01822886
Other Study ID Numbers  ICMJE FIL_GEMRO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fondazione Italiana Linfomi ONLUS
Study Sponsor  ICMJE Fondazione Italiana Linfomi ONLUS
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pier Luigi Zinzani Istituto Ematologia e Oncologia Medica "SERAGNOLI" Università di Bologna
PRS Account Fondazione Italiana Linfomi ONLUS
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP