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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Peripheral T-cell Lymphoma
Intervention Drug: Romidepsin + Gemcitabine
Enrollment 20
Recruitment Details date of first enrollment: 08 Jan 2013 date of last completed:15 Jul 2018
Pre-assignment Details  
Arm/Group Title Romidepsin, Gemcitabine
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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 (progressioni disease)

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.

Period Title: Overall Study
Started 20
Completed 5
Not Completed 15
Arm/Group Title Romidepsin, Gemcitabine
Hide Arm/Group Description

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

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.

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
  75.0%
>=65 years
5
  25.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
55
(24 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
10
  50.0%
Male
10
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 20 participants
20
1.Primary Outcome
Title Complete Remission (CR) Rate
Hide Description Complete Remission is disappearance of all target lesions per the Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007)"
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Romidepsin, Gemcitabine
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
3
  15.0%
2.Secondary Outcome
Title Percentage of Participants With Progression-Free Survival
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Romidepsin, Gemcitabine
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of partecipants
11.2
(3 to 25)
3.Secondary Outcome
Title Overall Survival is Measured From the Date of Study Entry to the Date of Patient's Death
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Romidepsin, Gemcitabine
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of partecipants
50
(28 to 72)
4.Secondary Outcome
Title Safety - Frequency of Toxicities Grade 3 and 4
Hide Description Frequency of toxicities was reported by type and grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Romidepsin, Gemcitabine
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: events
29
5.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description 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).
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Romidepsin, Gemcitabine
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
6
  30.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Romidepsin, Gemcitabine
Hide Arm/Group Description

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

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.

All-Cause Mortality
Romidepsin, Gemcitabine
Affected / at Risk (%)
Total   10/20 (50.00%)    
Hide Serious Adverse Events
Romidepsin, Gemcitabine
Affected / at Risk (%) # Events
Total   4/20 (20.00%)    
General disorders   
Fever with shiver, Hypotension, Desaturation  1  1/20 (5.00%)  1
Infections and infestations   
Pneumonia  1  1/20 (5.00%)  1
Nervous system disorders   
Ischaemic encephalopaty  1  1/20 (5.00%)  1
Renal and urinary disorders   
Fever, loss of consciousness and urinary infection  1  1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumothorax  1  1/20 (5.00%)  1
Dyspnea  1  1/20 (5.00%)  1
Fever and pulmonary insufficiency  1  1/20 (5.00%)  1
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Romidepsin, Gemcitabine
Affected / at Risk (%) # Events
Total   20/20 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  12/20 (60.00%)  12
Neutropenia  1  11/20 (55.00%)  11
Thrombocytopenia  1  16/20 (80.00%)  16
Febrile neutropenia  1  2/20 (10.00%)  2
Gastrointestinal disorders   
Nausea and vomiting  1  10/20 (50.00%)  10
General disorders   
Pyrexia  1  6/20 (30.00%)  6
Hepatobiliary disorders   
Transaminases increase  1  4/20 (20.00%)  4
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Zinzani Pier Luigi/Argnani Lisa
Organization: Policlinico S.Orsola-Malpighi - Institute of Hematology “L. e A. Seràgnoli”, University of Bologna, Via Massarenti, 9-40138 Bologna, Italy
Phone: +39 0516364042
EMail: pierluigi.zinzani@unibo.it/lisa.argnani@unibo.it
Layout table for additonal information
Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT01822886    
Other Study ID Numbers: FIL_GEMRO
First Submitted: March 28, 2013
First Posted: April 2, 2013
Results First Submitted: September 12, 2019
Results First Posted: October 10, 2019
Last Update Posted: October 14, 2019