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

NCT01280526 | Completed Phase 1 DMC

• 1 other identifier: Ro-CHOP
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 8

Brief 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.
• 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.

Conditions

Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Dose Limiting Toxicities

  42 days

Secondary Outcomes (6)

• Complete Response Rate(CR) at the end of treatment

  30 days after the end of treatment

• Progression-free survival (PFS)

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

• Duration of Response

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

• Safety of association Romidepsin-CHOP

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

• Overall Response at the end of treatment

  30 days after the end of treatment

Study Arms (4)

Romidepsin dose 10mg/m²

EXPERIMENTAL

Romidepsin dose 10mg/m²

Drug: Romidepsin and CHOP

Romidepsin dose 12mg/m²

EXPERIMENTAL

Romidepsin dose 12mg/m²

Drug: Romidepsin and CHOP

Romidepsin dose 14mg/m²

EXPERIMENTAL

Romidepsin dose 14mg/m²

Drug: Romidepsin and CHOP

Romidepsin dose 8mg/m²

EXPERIMENTAL

Romidepsin dose 8mg/m²

Drug: Romidepsin and CHOP

Interventions

Romidepsin and CHOP DRUG

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 dose 10mg/m²

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• Ann Arbor stages II - IV
• Aged from 18 to 80 years,
• ECOG performance status 0, 1 or 2,
• Signed informed consent,
• Negative pregnancy test for females of childbearing potential (FCBP),
• 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,
• Life expectancy of ≥ 90 days (3 months)

You may not qualify if:

• Other types of lymphomas, e.g. B-cell lymphoma
• Ann Arbor stage I
• Previous radiotherapy for PTCL except if localized to one lymph node area
• Central nervous system - meningeal involvement
• Contraindication to any drug contained in the chemotherapy regimen
• HIV infection, active hepatitis B or C
• Any serious active disease or co-morbid medical condition (according to investigator's decision)
• 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,
• Use of oral contraceptive and contraceptive patches,
• Calculated creatinine clearance (Cockcroft-Gault formula) of \< 50 mL /min,

Sponsors & Collaborators

• The Lymphoma Academic Research Organisation: lead

Study Sites (8)

Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU de Dijon

Dijon, 21000, France

Location

Hôpital Claude Huriez

Lille, 59037, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Hôpital St Louis

Paris, 75475, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (1)

• 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.

  PMID: 26687958 DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

romidepsin

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bertrand COIFFIER, Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 20, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: March 1, 2014
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

FR (8)