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
|Condition or disease||Intervention/treatment||Phase|
|Peripheral T-cell Lymphoma||Drug: Romidepsin, Gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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)
- 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).
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
|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|
|Principal Investigator:||Pier Luigi Zinzani||Istituto Ematologia e Oncologia Medica "SERAGNOLI" Università di Bologna - BOLOGNA|