Trial Outcomes & Findings for Phase II Study of Gemcitabine+Romidepsin in the Relapsed/Refractory Peripheral T-cell Lymphoma Patients (NCT NCT01822886)

Results Overview

Complete Remission is disappearance of all target lesions per the Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007)"

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

18 months

Results posted on

2019-10-14

Participant Flow

date of first enrollment: 08 Jan 2013 date of last completed:15 Jul 2018

Participant milestones

Participant milestones
Measure	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 (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.
Overall Study STARTED	20
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of Gemcitabine+Romidepsin in the Relapsed/Refractory Peripheral T-cell Lymphoma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Romidepsin, Gemcitabine n=20 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment Italy	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Complete Remission is disappearance of all target lesions per the Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007)"

Outcome measures

Outcome measures
Measure	Romidepsin, Gemcitabine n=20 Participants 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.
Complete Remission (CR) Rate	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Romidepsin, Gemcitabine n=20 Participants 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.
Percentage of Participants With Progression-Free Survival	11.2 percentage of partecipants Interval 3.0 to 25.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Romidepsin, Gemcitabine n=20 Participants 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 Survival is Measured From the Date of Study Entry to the Date of Patient's Death	50 percentage of partecipants Interval 28.0 to 72.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Romidepsin, Gemcitabine n=20 Participants 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.
Safety - Frequency of Toxicities Grade 3 and 4	29 events

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Romidepsin, Gemcitabine n=20 Participants 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 Response Rate (ORR)	6 Participants

Adverse Events

Romidepsin, Gemcitabine

Serious events: 4 serious events

Other events: 20 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Romidepsin, Gemcitabine n=20 participants at risk 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.
General disorders Fever with shiver, Hypotension, Desaturation	5.0% 1/20 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.0% 1/20 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnea	5.0% 1/20 • Number of events 1
Renal and urinary disorders Fever, loss of consciousness and urinary infection	5.0% 1/20 • Number of events 1
Respiratory, thoracic and mediastinal disorders Fever and pulmonary insufficiency	5.0% 1/20 • Number of events 1
Infections and infestations Pneumonia	5.0% 1/20 • Number of events 1
Nervous system disorders Ischaemic encephalopaty	5.0% 1/20 • Number of events 1

Other adverse events

Other adverse events
Measure	Romidepsin, Gemcitabine n=20 participants at risk 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.
Blood and lymphatic system disorders Anemia	60.0% 12/20 • Number of events 12
Blood and lymphatic system disorders Neutropenia	55.0% 11/20 • Number of events 11
Blood and lymphatic system disorders Thrombocytopenia	80.0% 16/20 • Number of events 16
Blood and lymphatic system disorders Febrile neutropenia	10.0% 2/20 • Number of events 2
Gastrointestinal disorders Nausea and vomiting	50.0% 10/20 • Number of events 10
General disorders Pyrexia	30.0% 6/20 • Number of events 6
Hepatobiliary disorders Transaminases increase	20.0% 4/20 • Number of events 4

Additional Information

Zinzani Pier Luigi/Argnani Lisa

Policlinico S.Orsola-Malpighi - Institute of Hematology "L. e A. Seràgnoli", University of Bologna, Via Massarenti, 9-40138 Bologna, Italy

Phone: +39 0516364042

Email: [email protected]/[email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place