This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Efficacy and Safety of Romidepsin CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by The Lymphoma Academic Research Organisation
Sponsor:
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier:
NCT01796002
First received: January 31, 2013
Last updated: March 8, 2017
Last verified: March 2017
  Purpose
Primary objective of the study is to compare the efficacy of romidepsin when administered with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma (PTCL) in terms of progression-free survival (PFS) assessed according to Response criteria for malignant lymphoma 1999 by RAC.

Condition Intervention Phase
Peripheral T-cell Lymphoma Drug: Romidepsin + CHOP Drug: CHOP Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: PHASE 3 MULTI-CENTER RANDOMIZED STUDY TO COMPARE EFFICACY AND SAFETY OF ROMIDEPSIN CHOP (Ro-CHOP) VERSUS CHOP IN PATIENTS WITH PREVIOUSLY UNTREATED PERIPHERAL T-CELL LYMPHOMA

Resource links provided by NLM:


Further study details as provided by The Lymphoma Academic Research Organisation:

Primary Outcome Measures:
  • The primary efficacy endpoint is Progression Free Survival (PFS) using the response criteria for malignant lymphoma (1999) by a RAC [ Time Frame: 60 months ]

Estimated Enrollment: 420
Study Start Date: January 2013
Estimated Study Completion Date: July 2024
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Romidepsin + CHOP

Patients in experimental arm receive romidepsin plus CHOP (Ro-CHOP) administered in 3 week cycles for 6 cycles.

Romidepsin is administered at a dose of 12 mg/m² IV on day 1 and day 8 every 3 weeks.

Drug: Romidepsin + CHOP
Ro-CHOP administered in 3 week cycles for 6 cycles or until progression Romidepsin is administered at a dose of 12 mg/m² IV on day 1 and day 8 every 3 weeks.
Active Comparator: CHOP
Patients in control Arm receive cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles.
Drug: CHOP
CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 6 cycles.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females of 18 years of age to 80 years of age.
  2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
  3. Able to adhere to the study visit schedule and other protocol requirements.
  4. Patients with histologically proven peripheral T-cell lymphoma (PTCL), not previously treated; the following subtypes as defined by the WHO classification (2008;2011) may be included, whatever the Ann Arbor stage (I - IV):

    a. Nodal types: i. PTCL, not otherwise specified ii. Angioimmunoblastic T-cell lymphoma iii. Anaplastic large cell lymphoma, ALK-negative type

    b. Extra-nodal types: i. Enteropathy-associated T-cell lymphoma ii. Hepato-splenic T-cell lymphoma iii. Subcutaneous panniculitis-like T-cell lymphoma iv. Primary cutaneous gamma-delta T-cell lymphoma v. Primary cutaneous CD8+ aggressive epidermotropic lymphoma vi. Primary cutaneous CD4+ small/medium T-cell lymphoma

    c. Other non classifiable peripheral T-cell lymphoma

  5. ECOG performance status 0, 1 or 2
  6. Negative pregnancy test for females of childbearing potential (FCBP)
  7. Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 1 month thereafter; Males must use an effective method of birth control during treatment period and 3 months thereafter.
  8. Life expectancy of ≥ 90 days (3 months).

Exclusion Criteria:

  1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.
  2. Any condition that confounds the ability to interpret data from the study.
  3. Other types of lymphomas, e.g. B-cell lymphoma
  4. The following types of T cell lymphomas:

    1. Adult T-cell lymphoma/leukemia (HTLV-1 related T-cell lymphoma)
    2. Extranodal T-cell/NK-cell lymphoma, nasal type
    3. Anaplastic large cell lymphoma, ALK-positive type
    4. Cutaneous T cell lymphoma (mycosis fungoid, Sézary syndrome)
    5. Primary cutaneous CD30+ T-cell lymphoproliferative disorder
    6. Primary cutaneous anaplastic T-cell lymphoma
  5. Previous treatment for PTCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of ≤ 8 days) before randomization
  6. Previous radiotherapy for PTCL except if localized to one lymph node area
  7. Patients planned for autologous or allogeneic transplant as consolidation in first line
  8. Central nervous system -meningeal involvement
  9. Contraindication to any drug contained in the chemotherapy regimen,
  10. Subjects with HIV positivity
  11. Subjects with active hepatitis B or C. Chronic carriers of hepatitis B without HBV DNA positive blood are eligible. Subjects with non-active hepatitis C (with normal transaminases) are eligible.
  12. Any of the following laboratory abnormalities, except if secondary to the lymphoma:

    1. Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L),
    2. Platelet count < 100,000/mm3 (100 x 109/L), or < 75,000/mm3 if bone marrow is involved,
    3. Serum SGOT/AST or SGPT/ALT ≥ 3.0 x upper limit of normal (ULN),
    4. Serum total bilirubin > 2 x ULN, except in case of hemolytic anemia,
    5. K+ and Mg2+ levels < LLN, except if corrected per protocol guidance before beginning the romidepsin infusion
  13. Serum creatinine > 2.0 x ULN
  14. 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 or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for ≥ 3 years
  15. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
  16. Any known cardiac abnormalities such as:

    1. Patients with congenital long QT syndrome
    2. Corrected QT interval > 480 msec (using the Fridericia formula)
    3. Myocardial infarction within 6 months of cycle 1 day 1
    4. History of or concomitant significant cardiovascular disease
    5. Ejection fraction <45% by MUGA scan or by echocardiogram;
  17. Concomitant use of drugs that may cause a significant prolongation of the QTc
  18. Patients who have received more than 200 mg/m2 doxorubicin
  19. Concomitant use of strong CYP3A4 inhibitors
  20. Concomitant use of therapeutic warfarin due to a potential drug interaction. Use of a low dose of warfarin or another anticoagulant to maintain patency of venous access port and cannulas is permitted.
  21. Clinically significant active infection
  22. Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug
  23. Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796002

Contacts
Contact: O'Brian SAINDOY +33 4 72 66 93 33 obrian.saindoy@lysarc.org
Contact: Thomas Pleau Pison +33 4 27 01 27 52 thomas.pleau-pison@lysarc.org

  Show 131 Study Locations
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Investigators
Principal Investigator: Bertrand COIFFIER, Professor CH Lyon Sud, Pierre Bénite, France
Principal Investigator: Richard DELARUE, MD Hôpital Necker, Paris, France
  More Information

Additional Information:
Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT01796002     History of Changes
Other Study ID Numbers: Ro-CHOP Study
Study First Received: January 31, 2013
Last Updated: March 8, 2017

Keywords provided by The Lymphoma Academic Research Organisation:
PTCL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Romidepsin
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 23, 2017