NCT01822886

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 10, 2019

Completed
Last Updated

October 14, 2019

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

March 28, 2013

Results QC Date

September 12, 2019

Last Update Submit

October 11, 2019

Conditions

Peripheral T-cell Lymphoma

Keywords

T-cell lymphomaRomidepsin

Outcome Measures

Primary Outcomes (1)

  • Complete Remission (CR) Rate

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

    18 months

Secondary Outcomes (4)

  • Percentage of Participants With Progression-Free Survival

    24 months

  • Overall Survival is Measured From the Date of Study Entry to the Date of Patient's Death

    24 months

  • Safety - Frequency of Toxicities Grade 3 and 4

    24 months

  • Overall Response Rate (ORR)

    24 months

Study Arms (1)

Romidepsin, Gemcitabine

EXPERIMENTAL

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 (progression disease)

Drug: Romidepsin + Gemcitabine

Interventions

Romidepsin + GemcitabineDRUG

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

Romidepsin, Gemcitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +4 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

A.O. SS. Antonio e Biagio e C. Arrigo

Alessandria, 15121, Italy

Location

Istituto di Ematologia ed Oncologia Medica A. Seragnoli Policlinico S. Orsola

Bologna, 40138, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

A.O. Universitaria Citta' Della Salute E Della Scienza Di Torino

Torino, 10126, Italy

Location

Related Publications (1)

  • Pellegrini C, Dodero A, Chiappella A, Monaco F, Degl'Innocenti D, Salvi F, Vitolo U, Argnani L, Corradini P, Zinzani PL; Italian Lymphoma Foundation (Fondazione Italiana Linfomi Onlus, FIL). A phase II study on the role of gemcitabine plus romidepsin (GEMRO regimen) in the treatment of relapsed/refractory peripheral T-cell lymphoma patients. J Hematol Oncol. 2016 Apr 12;9:38. doi: 10.1186/s13045-016-0266-1.

    PMID: 27071522DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, PeripheralLymphoma, T-Cell

Interventions

romidepsinGemcitabine

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

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
pierluigi.zinzani@unibo.it/lisa.argnani@unibo.it
+39 0516364042

Study Officials

  • Pier Luigi Zinzani

    Istituto Ematologia e Oncologia Medica "SERAGNOLI" Università di Bologna

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2013

First Posted

April 2, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2014

Study Completion

July 1, 2018

Last Updated

October 14, 2019

Results First Posted

October 10, 2019

Record last verified: 2018-08

Locations

IT(4)