Efficacy and Safety of Romidepsin CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma
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| ClinicalTrials.gov Identifier: NCT01796002 |
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Recruitment Status :
Completed
First Posted : February 21, 2013
Last Update Posted : January 10, 2023
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Sponsor:
The Lymphoma Academic Research Organisation
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation
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Brief Summary:
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 a Response Adjudication Committee (RAC).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Peripheral T-cell Lymphoma | Drug: Romidepsin + CHOP Drug: CHOP | Phase 3 |
This is a randomized multi-center phase III study, to compare efficacy and safety of Ro-CHOP with standard CHOP regimen in patients with previously untreated, histologically proven PTCL. Given the nature of the experimental agent, this study is an open-label study. Patients are randomized 1:1 to receive either (Arm A) cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles [22] or (Arm B) romidepsin CHOP (Ro-CHOP) administered in 3 week cycles for 6 cycles. In the Ro-CHOP arm, romidepsin will be administered at a dose of 12 mg/m² IV on day 1 and day 8 every 3 weeks. In this study, patients will advance through three phases of the study: screening phase, treatment phase and follow-up phase. Patients will receive study drug(s) for up to 6 cycles, or until unacceptable toxicity will develop or progression or voluntary withdrawal. Patients will be followed for survival until the earliest of either 80% of patients have died or 3 years from the last patient randomized. Three years after the primary analysis an update of the database will be done and a rerun of the analysis will be performed.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 421 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| 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 |
| Actual Study Start Date : | January 2013 |
| Actual Primary Completion Date : | December 13, 2019 |
| Actual Study Completion Date : | December 13, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Romidepsin
| Arm | Intervention/treatment |
|---|---|
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Experimental: Experimental: Romidepsin plus 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. |
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Active Comparator: Standard: CHOP
Patients in control Arm receive cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles.
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Drug: CHOP
CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 6 cycles. |
Primary Outcome Measures :
- The primary efficacy endpoint is Progression Free Survival [ Time Frame: 60 months ]The primary efficacy endpoint is Progression Free Survival (PFS) using the response criteria for malignant lymphoma (1999) by a Response Adjudication Committee
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and females of 18 years of age to 80 years of age.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- Able to adhere to the study visit schedule and other protocol requirements.
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Patients with histologically proven peripheral T-cell lymphoma (PTCL), not previously treated; the following subtypes as defined by the World Health Organization (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, anaplastic lymphoma kinase (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 cluster of differentiation 8 positive (CD8+) aggressive epidermotropic lymphoma vi. Primary cutaneous cluster of differentiation 4 positive (CD4+) small/medium T-cell lymphoma
c. Other non classifiable peripheral T-cell lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Negative pregnancy test for Females of ChildBearing Potential (FCBP)
- 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.
- Life expectancy of ≥ 90 days (3 months).
Exclusion Criteria:
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.
- Any condition that confounds the ability to interpret data from the study.
- Other types of lymphomas, e.g. B-cell lymphoma
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The following types of T cell lymphomas:
- Adult T-cell lymphoma/leukemia (HTLV-1 related T-cell lymphoma)
- Extranodal T-cell/Natural Killer (NK)-cell lymphoma, nasal type
- Anaplastic large cell lymphoma, ALK-positive type
- Cutaneous T cell lymphoma (mycosis fungoid, Sézary syndrome)
- Primary cutaneous cluster of differentiation antigen 30 positive (CD30+) T-cell lymphoproliferative disorder
- Primary cutaneous anaplastic T-cell lymphoma
- Previous treatment for PTCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of ≤ 8 days) before randomization
- Previous radiotherapy for PTCL except if localized to one lymph node area
- Patients planned for autologous or allogeneic transplant as consolidation in first line
- Central nervous system -meningeal involvement
- Contraindication to any drug contained in the chemotherapy regimen,
- Subjects with HIV positivity
- Subjects with active hepatitis B or C. Chronic carriers of Hepatitis B virus (HBV) without HBV DNA positive blood are eligible. Subjects with non-active hepatitis C (with normal transaminases) are eligible.
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Any of the following laboratory abnormalities, except if secondary to the lymphoma:
- 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/mm3 if bone marrow is involved,
- Serum Aspartate Aminotransferase (ASAT/AST) or Alanine Aminotransferase (ALAT/ALT) ≥ 3.0 x Upper Limit of Normal (ULN),
- Serum total bilirubin > 2 x ULN, except in case of hemolytic anemia,
- K+ and Mg2+ levels < Lower Limit of Normal (LLN), except if corrected per protocol guidance before beginning the romidepsin infusion
- Serum creatinine > 2.0 x ULN
- 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
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
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Any known cardiac abnormalities such as:
- Patients with congenital long QT syndrome
- Corrected QT interval > 480 msec (using the Fridericia formula)
- Myocardial infarction within 6 months of cycle 1 day 1
- History of or concomitant significant cardiovascular disease
- Ejection fraction <45% by multigated acquisition (MUGA) scan or by echocardiogram;
- Concomitant use of drugs that may cause a significant prolongation of the corrected QT interval (QTc)
- Patients who have received more than 200 mg/m2 doxorubicin
- Concomitant use of strong CYP3A4 inhibitors
- 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.
- Clinically significant active infection
- Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796002
Locations
Show 131 study locations
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Investigators
| Study Chair: | Emmanuel BACHY, Professor | CH Lyon Sud, Pierre Bénite, France | |
| Study Chair: | Vincent CAMUS, MD | Centre Henri Becquerel, Rouen, France |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | The Lymphoma Academic Research Organisation |
| ClinicalTrials.gov Identifier: | NCT01796002 |
| Other Study ID Numbers: |
Ro-CHOP Study |
| First Posted: | February 21, 2013 Key Record Dates |
| Last Update Posted: | January 10, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by The Lymphoma Academic Research Organisation:
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PTCL |
Additional relevant MeSH terms:
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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 Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |