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Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma (ROBUST)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Celgene
Sponsor:
Information provided by (Responsible Party):
Celgene
ClinicalTrials.gov Identifier:
NCT02285062
First received: November 4, 2014
Last updated: May 31, 2017
Last verified: May 2017
  Purpose
To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in patients who have previously untreated ABC type DLBCL.

Condition Intervention Phase
Lymphoma, Large B-Cell, Diffuse Drug: lenalidomide Drug: Placebo Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: prednisone Drug: vincristine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of Lenalidomide (CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects With Previously Untreated Activated B-cell Type Diffuse Large B-cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Celgene:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Up to 5 years from the time the last patient is randomized ]
    Number of participants who survive without progressing


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Up to 5 years from the time the last patient is randomized ]
    Proportion of patients who survive

  • Complete Response Rate [ Time Frame: Up to 5 years from the time the last patient is randomized ]
    Proportion of patients who have a complete response prior to any treatment change

  • Duration of Complete Response [ Time Frame: Up to 5 years from the time the last patient is randomized ]
    Calculated only for patients who have a complete response. Time from the first complete response prior to treatment change to the first event of disease progression or death

  • Time to Next Lymphoma Treatment [ Time Frame: Up to 5 years from the time the last patient is randomized ]
    Time from randomization to the time of treatment change to the next lymphoma treatment

  • Objective Response Rate [ Time Frame: Up to 5 years from the time the last patient is randomized ]
    Proportion of patients who have either a complete or partial response before any treatment change

  • Health Related Quality of Life [ Time Frame: Up to 5 years from the time the last patient is randomized ]
    Differences in health related quality of life will be compared between the two treatment groups

  • Event Free Survival [ Time Frame: Up to 5 years ]
    Number of patients who survive without receiving a second anti-lymphoma treatment.


Estimated Enrollment: 560
Actual Study Start Date: January 21, 2015
Estimated Study Completion Date: September 30, 2022
Estimated Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: R2-CHOP
lenalidomide plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)
Drug: lenalidomide Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: prednisone Drug: vincristine
Active Comparator: R-CHOP
placebo plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)
Drug: Placebo Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: prednisone Drug: vincristine

Detailed Description:

This research study is for patients with newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL) of the activated B-cell (ABC) type who have not yet been treated. DLBCL is a cancer of a type of blood cell called B-lymphocytes. B lymphocytes are part of the body's immune system. There are different types of DLBCL. About a third of newly diagnosed DLBCL cancers are the ABC type. It has been observed that treatment does not work as well for patients with the ABC type compared to patients with other DLBCL types who receive standard treatment. However, at this time both ABC type and other DLBCL type patients receive the same standard treatments.

Patients with DLBCL who are otherwise healthy are usually treated first with the chemotherapy drug combination called R-CHOP. The drugs in this combination are "R" for rituximab, "C" for cyclophosphamide, "H" for doxorubicin which has a chemical name of hydroxydaunomycin, "O" for vincristine which has a trade name of oncovin, and "P" for prednisone. Depending on the local practice where you are treated, R-CHOP may be given for 6 or 8 cycles. A cycle could lasts for 14 or 21 days. The R-CHOP drug combination is approved for the treatment of DLBCL of all types, including ABC type. R-CHOP is standard care.

This study will test the standard R-CHOP21 against R-CHOP21 plus lenalidomide. The purpose is to see whether adding lenalidomide works better and is as safe as R-CHOP by itself. This study is only for patients with ABC type DLBCL who have not yet been treated. Lenalidomide is not approved for use in DLBCL. Its use in this disease is experimental. In this study, the experimental treatment is lenalidomide + R-CHOP21 x 6.

This study will use a gene expression profile (GEP) test to see if a patient has the ABC type. The results of this GEP test affect whether you may be treated on this study. Because the performance of this test has not been proven, it is for investigational use only, and is still under development. This means the GEP test is an experimental test.

  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. Histologically proven Diffuse Large B-Cell Lymphoma of the Activated B-Cell type
  2. Newly diagnosed, previously untreated Diffuse Large B-Cell Lymphoma
  3. Measurable Diffuse Large B-Cell Lymphoma disease by Computed Tomography (CT) / Magnetic Resonance Imagining (MRI) scans
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
  5. Age 18 - 80 years; age > 80 allowed at investigator discretion if performance status ≤ 1; and each organ system score ≤ 2 using cumulative illness rating scale (CIRS)

Exclusion Criteria:

  1. Diagnosis of lymphoma histologies other than Diffuse Large B-Cell Lymphoma
  2. History of malignancies, other than Diffuse Large B-Cell Lymphoma, unless the patient has been disease free for 5 years or more
  3. Known seropositive for, or history of, active Human Immunodeficiency Virus (HIV) Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
  4. Contraindication to any drug in the chemotherapy regimen, and specifically: LVEF (Left Ventricular Ejection Fraction) < 45% or peripheral neuropathy grade 2
  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: NCT02285062

Contacts
Contact: Associate Director, Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

  Show 286 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Lei Zhang, M.D Celgene Corporation
  More Information

Publications:
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02285062     History of Changes
Other Study ID Numbers: CC-5013-DLC-002
2013-004054-21 ( EudraCT Number )
Study First Received: November 4, 2014
Last Updated: May 31, 2017

Keywords provided by Celgene:
R-CHOP chemotherapy
DLBCL front line therapy
gene expression profiling (GEP) activated B-cell (ABC) type DLBCL biomarkers
Activated B-Cell (ABC) type
Diffuse Large B-Cell Lymphoma, not otherwise specified
Diffuse Large B-Cell Lymphoma, associated with chronic inflammation
Diffuse Large B-Cell Lymphoma, Epstein-Barr virus positive (EBS+) of the elderly
Diffuse Large B-Cell Lymphoma, T-cell / histiocyte-rich

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Doxorubicin
Liposomal doxorubicin
Lenalidomide
Prednisone
Thalidomide
Cyclophosphamide
Rituximab
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on June 26, 2017