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

Phase IIa Study on the Role of Gemcitabine Plus Romidepsin (GEMRO Regimen) in the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma Patients.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01822886

Acronym

FIL_GEMRO

Enrollment

Registered

2013-04-02

Start date

2013-01-31

Completion date

2018-07-31

Last updated

2019-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral T-cell Lymphoma

Keywords

T-cell lymphoma, Romidepsin

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.

Interventions

DRUGRomidepsin + 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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Complete Remission (CR) Rate	18 months	Complete Remission is disappearance of all target lesions per the Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007)

Secondary

Measure	Time frame	Description
Percentage of Participants With Progression-Free Survival	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	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	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)	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).

Countries

Italy

Participant flow

Recruitment details

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

Participants by arm

Arm	Count
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 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.	20
Total	20

Baseline characteristics

Characteristic	Romidepsin, Gemcitabine
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	5 Participants
Age, Categorical Between 18 and 65 years	15 Participants
Age, Continuous	55 years
Region of Enrollment Italy	20 participants
Sex: Female, Male Female	10 Participants
Sex: Female, Male Male	10 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	10 / 20
other Total, other adverse events	20 / 20
serious Total, serious adverse events	4 / 20

Arm	Measure	Value (NUMBER)
Romidepsin, Gemcitabine	Safety - Frequency of Toxicities Grade 3 and 4	29 events

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026