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

Phase 2
18 Years
Open (Enrolling)
Peripheral T-cell Lymphoma

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Trial Information

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

Inclusion Criteria:

- Patients with histological diagnosis of PTCL according to the WHO classification

- Age ≥ 18 years

- Relapsed (≥1) or refractory to conventional chemotherapy/radiotherapy

- Stage I-IV according to the Ann Arbor staging System

- ECOG 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

- Patients or they legally authorized representative must provide written informed

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 Fredericia 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

- History of clinically relevant liver or renal insufficiency; significant cardiac,
vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic,
hematologic, psychiatric, or metabolic disturbances

- Active opportunistic infection

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

CR rate

Outcome Description:

The proportion of patients with complete remission (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007).

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Pier Luigi Zinzani

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Ematologia e Oncologia Medica "SERAGNOLI" Università di Bologna - BOLOGNA


Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:




Start Date:

September 2012

Completion Date:

September 2015

Related Keywords:

  • Peripheral T-cell Lymphoma
  • T-cell lymphoma
  • Romidepsin
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral