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Peripheral T Cell LymphomaPhase 1/2Ro-CHOPNCT01280526

A Study of Escalating Doses of Romidepsin in Association With CHOP in the Treatment of Peripheral T-Cell Lymphomas

A Phase 1/2 study testing Romidepsin and CHOP in people with Peripheral T Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 8 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is an open label, multicenter study with two phases: A dose escalation phase of Romidepsin administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)administered every 3 weeks for 8 cycles in patients with T-cell lymphoma. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Peripheral T Cell Lymphoma
What is being tested?
Romidepsin and CHOP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
8 sitesFrance
Study dates
Jan 2011to Mar 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Inclusion Criteria:
  2. Patients with histologically confirmed Peripheral T-cell Lymphoma (PTCL), not previously treated ; all subtypes may be included except HTLV-1-related T-cell lymphoma, cutaneous T-cell lymphoma (mycosis fungoid and Sézary syndrome), and ALK+ PTCL,
  3. Ann Arbor stages II - IV
  4. Aged from 18 to 80 years,
  5. ECOG performance status 0, 1 or 2,
  6. Signed informed consent,
  7. Negative pregnancy test for females of childbearing potential (FCBP),
  8. FCBP using an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) for the treatment period and for 1 month thereafter; Males using an effective method of birth control for the treatment period and 3 months thereafter,
  9. Life expectancy of ≥ 90 days (3 months)
  10. Exclusion Criteria:
  11. Other types of lymphomas, e.g. B-cell lymphoma
  12. Ann Arbor stage I
  13. Previous treatment for PTCL with immunotherapy or chemotherapy except for short-term corticosteroids before inclusion
  14. Previous radiotherapy for PTCL except if localized to one lymph node area
  15. Central nervous system - meningeal involvement
  16. Contraindication to any drug contained in the chemotherapy regimen
  17. HIV infection, active hepatitis B or C
  18. Any serious active disease or co-morbid medical condition (according to investigator's decision)
  19. Any of the following laboratory abnormalities
  • Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L),
  • Platelet count < 100,000/mm3 (100 x 109/L), or 75,000 if bone marrow is involved,
  • Serum SGOT/AST or SGPT/ALT ≥ 5.0 x upper limit of normal (ULN),
  • Serum total bilirubin > 2.0 mg/dL (34 µmol/L), except in case of hemolytic anemia,
  • Low K+ (inferior to low normal level) and low Mg+ (inferior to low normal level)levels, except if corrected before beginning the chemotherapy,
  1. Use of oral contraceptive and contraceptive patches,
  2. Calculated creatinine clearance (Cockcroft-Gault formula) of < 50 mL /min,
  3. 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,
  4. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form,
  5. Left Ventricular Ejection Fraction < 45% (calculated by echocardiographic or scintigraphic methods),
  6. Patients with congenital long QT syndrome, history of significant cardiovascular disease and/or taking drugs leading to significant QT prolongation,
  7. Corrected QT interval > 480 msec (using the fridericia formula)
  8. Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug ,
  9. Pregnant or lactating females or women of childbearing potential not will-ing to use an adequate method of birth control for the duration of the study.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites

  • Hôpital Henri Mondor

    Créteil, 94010

  • CHU de Dijon

    Dijon, 21000

  • Hôpital Claude Huriez

    Lille, 59037

  • Centre Léon Bérard

    Lyon, 69373

  • Hôpital St Louis

    Paris, 75475

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: A Phase IB/II Study of Escalating Doses of Romidepsin (Istodax®) in Association With CHOP (Ro-CHOP) in the Treatment of Peripheral T-Cell Lymphomas

This study is an open label, multicenter study with two phases:

  • A dose escalation phase of Romidepsin administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)administered every 3 weeks for 8 cycles in patients with T-cell lymphoma.
  • An expansion phase in order to assess the safety and the efficacy of the association of the recommended dose of Romidepsin associated with CHOP in a population of patients with T-cell lymphoma.
Read the detailed description

The primary objective of the study is to determine the feasibility of the combination and the recommended dose (RD) of Romidepsin when administered in association with CHOP in a population of patients with newly diagnosed Peripheral T-cell lymphoma (PTCL) as measured by the toxicities during treatment.

Secondary objectives:

  • To assess the safety of the association Romidepsin and CHOP,
  • To assess the efficacy of the association of Romidepsin and CHOP: response rate and complete response rate, progression-free survival, response duration and overall survival.
Being tested
Romidepsin and CHOP
Medical subject headings
Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Romidepsin and CHOPDrug

    Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma

  • Romidepsin and CHOPDrug

    Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma

  • Romidepsin and CHOPDrug

    Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma

  • Romidepsin and CHOPDrug

    Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma

Study groups in NCT01280526
Study groupRoleWhat they receive
Romidepsin dose 10mg/m²ExperimentalRomidepsin dose 10mg/m²
Receives: Drug: Romidepsin and CHOP
Romidepsin dose 12mg/m²ExperimentalRomidepsin dose 12mg/m²
Receives: Drug: Romidepsin and CHOP
Romidepsin dose 14mg/m²ExperimentalRomidepsin dose 14mg/m²
Receives: Drug: Romidepsin and CHOP
Romidepsin dose 8mg/m²ExperimentalRomidepsin dose 8mg/m²
Receives: Drug: Romidepsin and CHOP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose Limiting Toxicities

    Measured: 42 days

Secondary outcomes (6)

  1. Complete Response Rate(CR) at the end of treatment

    Measured: 30 days after the end of treatment

  2. Progression-free survival (PFS)

    Measured: from the date of inclusion to the date of first documentated disease progression, relapse or death from any cause

  3. Duration of Response

    Measured: from the date of first documentation of a response to the date of first documented evidence of progression/relapse or death from any cause

  4. Safety of association Romidepsin-CHOP

    Toxicities occured during the trial for all patient from the date of informed consent signature to 90 days after the last drug administration will be measured and reported for all grades toxicities according to CTCAE v4.

    Measured: from the date of informed consent signature to 90 days after the last drug administration

  5. Overall Response at the end of treatment

    Measured: 30 days after the end of treatment

  6. Overall Survival (OS)

    Measured: from the date of inclusion to the date of first documentated disease progression, relapse or death from any cause

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionNov 2012
  4. Study completionMar 2014

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01280526
Sponsor's protocol ID
Ro-CHOP
Acronym
Ro-CHOP
Status last verified
May 2014
First submitted
14 Jan 2011
Last updated
22 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Dupuis J, Morschhauser F, Ghesquieres H, Tilly H, Casasnovas O, Thieblemont C, Ribrag V, Bossard C, Le Bras F, Bachy E, Hivert B, Nicolas-Virelizier E, Jardin F, Bastie JN, Amorim S, Lazarovici J, Martin A, Coiffier B. Combination of romidepsin with cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated patients with peripheral T-cell lymphoma: a non-randomised, phase 1b/2 study. Lancet Haematol. 2015 Apr;2(4):e160-5. doi: 10.1016/S2352-3026(15)00023-X. Epub 2015 Mar 17.

    PubMed 26687958

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Romidepsin and CHOP in people with Peripheral T Cell Lymphoma, run by The Lymphoma Academic Research Organisation at 8 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of Dose Limiting Toxicities (time frame: 42 days). 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 NCT01280526, 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 22 May 2014.

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