Peripheral T-cell LymphomaPhase 2FIL_GEMRONCT01822886
Phase II Study of Gemcitabine+Romidepsin in the Relapsed/Refractory Peripheral T-cell Lymphoma Patients
A Phase 2 study testing Romidepsin + Gemcitabine in people with Peripheral T-cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- Romidepsin + Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesItaly
- Study dates
- Jan 2013to Jul 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
A.O. SS. Antonio e Biagio e C. Arrigo
Alessandria, 15121
Istituto di Ematologia ed Oncologia Medica A. Seragnoli Policlinico S. Orsola
Bologna, 40138
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
A.O. Universitaria Citta' Della Salute E Della Scienza Di Torino
Torino, 10126
About this study
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.
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.
Read the detailed description
Objectives will be focused on preliminary dose-response, type of patients, frequency of dosing, and safety and tolerability profile.
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- Romidepsin + Gemcitabine
- Keywords
- T-cell lymphoma, Romidepsin
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Romidepsin + Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission (CR) Rate
Complete Remission is disappearance of all target lesions per the Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007)"
Measured: 18 months
Secondary outcomes (4)
Percentage of Participants With Progression-Free Survival
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.
Measured: 24 months
Overall Survival is Measured From the Date of Study Entry to the Date of Patient's Death
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.
Measured: 24 months
Safety - Frequency of Toxicities Grade 3 and 4
Frequency of toxicities was reported by type and grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
Measured: 24 months
Overall Response Rate (ORR)
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).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pier Luigi Zinzani, Principal investigator, Istituto Ematologia e Oncologia Medica "SERAGNOLI" Università di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822886
- Sponsor's protocol ID
- FIL_GEMRO
- Acronym
- FIL_GEMRO
- Status last verified
- Aug 2018
- First submitted
- 28 Mar 2013
- Last updated
- 14 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27071522
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01822886
- Acronym / sponsor ID
- FIL_GEMRO / FIL_GEMRO
- Conditions
- Peripheral T-cell Lymphoma
- Keywords
- T-cell lymphoma, Romidepsin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Posted 10 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Romidepsin, Gemcitabine | Experimental | Drug: Romidepsin + GemcitabineRomidepsin 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Romidepsin + GemcitabineRomidepsin 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 | Drug | Romidepsin, Gemcitabine |
Primary outcome
Complete Remission (CR) Rate
Time frame: 18 months
Complete Remission is disappearance of all target lesions per the Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007)"
4 secondary outcomes
Percentage of Participants With Progression-Free Survival
Time frame: 24 months
Overall Survival is Measured From the Date of Study Entry to the Date of Patient's Death
Time frame: 24 months
Safety - Frequency of Toxicities Grade 3 and 4
Time frame: 24 months
Overall Response Rate (ORR)
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27071522Pellegrini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pier Luigi Zinzani principal investigator
Istituto Ematologia e Oncologia Medica "SERAGNOLI" Università di Bologna
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Romidepsin + Gemcitabine in people with Peripheral T-cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Remission (CR) Rate (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01822886, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.