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Clinical Trials List

Protocol NumberCC-5013-DLC-002
NCT Number(ClinicalTrials.gov Identfier)NCT02285062

2016-03-01 - 2023-03-01

Phase III

Terminated5

ICD-10C83.33

Diffuse large B-cell lymphoma, intra-abdominal lymph nodes

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

  • Trial Applicant

    PPD DEVELOPMENT (HK) LIMITED

  • Sponsor

    Celgene Corporation

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 陳志丞 Division of Hematology & Oncology
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 王銘崇 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Su-Peng Yeh 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Po-Nan Wang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator MING YAO Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Condition/Disease

Previously Untreated Activated B-cell Type Diffuse Large B-cell Lymphoma

Objectives

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 subjects who have previously untreated ABC type DLBCL.

Test Drug

Lenalidomide (CC-5013)

Active Ingredient

Lenalidomide (CC-5013)

Dosage Form

capsule

Dosage

15mg, 10mg, 5mg, 2.5mg

Endpoints

Primary Outcome Measures :
1. Kaplan-Meier Estimate of Progression Free Survival (PFS) [ Time Frame: From the date of randomization up to the data cut off date of 15 March 2019; median follow-up of 24.5 months ]
Secondary Outcome Measures :
1. Kaplan-Meier (K-M) Estimate of Event Free Survival (EFS) [ Time Frame: From the date of randomization up to the data cut off date of 15 March 2019; median follow-up was 24.5 months ]
2. K-M Estimate of Overall Survival (OS) [ Time Frame: From the date of randomization up to the data cut off date of 15 March 2019; median follow-up was 24.5 months ]
3. Percentage of Participants Who Achieved a Complete Response (CR) [ Time Frame: From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months ]
4. Percentage of Participants Who Achieved an Objective Response [ Time Frame: From randomization date up to the data cut off date of 15 March 2019; median total treatment duration was 18.10 weeks for both treatment arms; range = 1.6 to 29.0 weeks for R2-CHOP arm and 0.3 to 22.9 weeks for placebo-R-CHOP arm ]
5. K-M Estimate of Duration of Complete Response [ Time Frame: From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months. ]
6. K-M Estimate of Time to Next Lymphoma Therapy (TTNLT) [ Time Frame: From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months ]
7. Number of Participants With a Treatment Emergent Adverse Event (TEAE) [ Time Frame: From the first dose of study treatment up to 28 days after the last dose of LEN/placebo or any component of R-CHOP including the optional 2 additional doses of rituximab if administered; up to 15 March 2019; maximum treatment duration = 29 months ]
8. Percentage of Participants Who Completed the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire [ Time Frame: Screening, Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 ]

9. Percentage of Participants Who Completed the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Health Related Quality of Life (HR-QoL) Questionnaire [ Time Frame: Screening, Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 ]
10. Mean Change From Baseline in the FACT-Lym Physical Well-Being Subscale [ Time Frame: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 ]
11. Mean Change From Baseline in the FACT-Lym Additional Concerns Subscale [ Time Frame: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 ]
12. Mean Change From Baseline in the FACT-Lym Functional Well-Being Subscale [ Time Frame: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 ]
13. Mean Change From Baseline in the FACT-Lym Trial Outcome Index (TOI) [ Time Frame: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 ]
14. Mean Change From Baseline in the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Index Score [ Time Frame: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 ]
15. Mean Change From Baseline in the EQ-5D-3L Visual Analogue Scale (VAS) [ Time Frame: Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 ]

Inclution Criteria

Inclusion Criteria
Subjects must satisfy the following criteria to be enrolled in the study:
1. Histologically confirmed CD20+ DLBCL of the below World Health Organization
(WHO) sub-classifications as assessed by Central Pathology. In the rare case that local
and Central pathology disagree on diagnosis, and if ABC type is confirmed by Central
Pathology (inclusion criterion 2), then the subject may still be enrolled on the basis of a
local DLBCL diagnosis at investigator discretion. A retrospective adjudication will be
performed by a second Central Pathologist.
a. Not otherwise specified (NOS)
b. Associated with chronic inflammation
c. Epstein-Barr virus positive (EBV+) of the elderly
2. ABC type determined using a validated GEP assay performed on NanoString’s
nCounter® Dx Analysis System as assessed by Central Pathology. (ABC type subjects
are reported by the GEP assay as eligible for this inclusion criterion, whereas subjects
with an indeterminate, unclassifiable, or GCB type are not eligible).
3. Adequate lymph node or tumor biopsy specimen available for Central Pathology review
and GEP profiling by the NanoString nCounter® Dx Analysis System. A formalin fixed
paraffin embedded lymph node or tumor biopsy acquired by a surgical incision or
excision biopsy is strongly preferred. Core needle biopsy is allowed, and typically 3 – 4
passes embedded in two FFPE blocks are adequate for both local and Central Pathology
evaluation (one block for local and one block for Central Pathology). Other commonly
used devices (e.g. endoscopy forceps or grasp biopsy) are also acceptable provided they
yield an equivalent amount of tissue. Material from a fine needle aspiration is not
acceptable. If an archival specimen is not available or is not acceptable, a re-biopsy is
required prior to randomization.
4. Measurable disease on cross section imaging by CT that is at least 1.5 cm in the longest
diameter and measurable in two perpendicular dimensions.
5. Ann Arbor stage II-IV disease.
6. No prior treatment for DLBCL, except as allowed in Section 8.2.1.
7. Appropriate candidate for 6 cycles of R-CHOP21.
8. International Prognostic Index score of 2 or greater.
9. Performance status < 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
10. Must be between the ages of 18 and 80 years on the date of the informed consent
document signature. At the discretion of the investigator, subjects over 80 years may be
included if their ECOG performance status is ≤ 1; each of their individual organ system
scores is ≤ 2 using the Modified Cumulative Illness Rating Scale (CIRS) for co-morbitidy
(Salvi, 2008; Salvi, 2008a); and if they would otherwise be eligible for full-dose RCHOP per local practice.
11. Must fulfill the following laboratory requirements:
a. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
(1.5 x 109
/L) unless secondary to
bone marrow or spleen involvement by lymphoma as demonstrated by recent bone
marrow aspiration and bone marrow biopsy or splenomegaly, in this case the limit is
≥ 1,000 cells/mm3
(1.0 x 109
/L)
b. Platelet count ≥ 75,000/mm3 (75 x 109
/L) unless secondary to bone marrow or spleen
involvement by lymphoma as demonstrated by recent bone marrow aspiration and
bone marrow biopsy or splenomegaly, in this case the limit is ≥ 50,000/ mm3 (50 x
109
/L)
c. Hemoglobin ≥ 7.5 g/dL (4.7 mmol/L)
d. Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤
3.0 x upper limit of normal (ULN). In the case of documented liver involvement by
lymphoma, the requirement is ≤ 5.0 x ULN.
e. Serum total bilirubin ≤ 2.0 mg/dl (34 µmol/L). In the case of Gilberts Syndrome, or
documented liver or pancreatic involvement by lymphoma, the requirement is ≤ 5.0
mg/dl (86 µmol/L).
f. Calculated creatinine clearance (Cockcroft-Gault formula) of ≥ 30 mL/min
12. Understand and voluntarily sign an informed consent document prior to conducting study
assessments or procedures.
13. Able to adhere to the study visit schedule and other protocol requirements.
14. Females of childbearing potential (FCBP) must:
a. Have two negative pregnancy tests as verified by the study doctor prior to starting
study therapy. She must agree to ongoing pregnancy testing during the course of the
study, and after end of study therapy. This applies even if the subject practices
complete abstinence1
from heterosexual contact.
b. Either commit to complete abstinence1
from heterosexual contact (which must be
reviewed on a monthly basis) or agree to use, and be able to comply with, effective
contraception without interruption, 28 days prior to starting study therapy, during the
study therapy (including dose interruptions), and for 12 months after discontinuation
of study therapy.
15. Male subjects must:
a. Practice complete abstinence1
or agree to use a condom during sexual contact with a
pregnant female or a female of childbearing potential while participating in the study,
during dose interruptions and for at least 28 days following investigational product
discontinuation, even if he has undergone a successful vasectomy.
b. Agree to not donate semen during investigational product therapy and for 28 days
after discontinuation of investigational product therapy.
16. All subjects must:
a. Have an understanding that the investigational product could have a potential
teratogenic risk.
b. Agree to abstain from donating blood while taking investigational product therapy
and for 28 days after discontinuation of investigational product therapy.
c. Agree not to share investigational product with another person.
d. Agree to be counseled about pregnancy precautions and risk of fetal exposure.
e. Females must agree to abstain from breastfeeding during study participation and for
at least 12 months after investigational product discontinuation.

Exclusion Criteria

Exclusion Criteria
The presence of any of the following will exclude a subject from enrollment:
1. The following WHO subcategories of DLBCL:
a. Active CNS or meningeal lymphoma
b. Primary cutaneous, leg type
c. Primary mediastinal (thymic)
d. Lymphomatoid granulomatosis
e. ALK-positive lymphoma
f. Plasmablastic lymphoma
g. Large B-cell lymphoma arising in HHV8 associated multicentric Castleman disease
h. Primary effusion lymphoma
i. Intravascular large B-cell
j. B-cell unclassifiable cases with features intermediate between DLBCL and Burkitt
k. Unclassifiable cases with features intermediate between DLBCL and classical
Hodgkin’s lymphoma
l. T cell / histiocyte rich.
2. Post-transplant Lymphoproliferative Disorder (PTLPD) cases, even if they are B-cell
type and ABC subtype, are excluded.
3. Histology other than DLBCL. Evidence of composite DLBCL and FL, or of
transformed NHL.
4. Seropositive for or active viral infection with hepatitis B virus (HBV):
a. HBV surface antigen (HBsAg) positive
b. HBV surface antigen (HBsAg) negative, HBV surface antibody (anti-HBs) positive
and/or HBV core antibody (anti-HBc) positive, and detectable viral DNA
Notes:
c. Subjects who are seropositive because of a successfully treated, prior infection are
eligible (HBsAg negative, anti-HBs positive, and/or anti-HBc positive, but viral DNA
negative)
d. Subjects who are seropositive because of HBV vaccination are eligible (anti-HBs
positive, anti-HBc negative, and HBsAg negative)
5. Hepatitis C virus (HCV) positive subjects with chronic hepatitis C, or subjects with an
active hepatitis C infection requiring anti-viral medication (at time of randomization).
Note:
a. HCV positive subjects who do not have active hepatitis C, and who are otherwise
acceptable candidates for R-CHOP chemotherapy, as documented by the investigator,
are eligible.
6. Known seropositive for or active viral infection with human immunodeficiency virus
(HIV).
7. Contraindication to any drug in the chemotherapy regimen, and specifically:
a. LVEF < 45% as assessed by MUGA, or LVEF < local institutional normal limits for
R-CHOP administration as assessed by echocardiography
b. Peripheral neuropathy ≥ Grade 2
8. Major surgery (excluding lymph node or bone marrow biopsy) within 28 days from
signing the informed consent document, unless the subject is recovered
9. Life expectancy < 6 months
10. History of other malignancies, unless the subject has been free of the disease for ≥ 5
years. Exceptions to the ≥ 5-year time limit include history of the following:
a. Localized non-melanoma skin cancer
b. Carcinoma in situ of the cervix
11. Prior use of lenalidomide
12. Known allergy to thalidomide
13. Known sensitivity or allergy to murine products
14. Use of any investigational agent within 28 days or five half lives, whichever is longer,
of Cycle 1 Day 1
15. Subjects who are unwilling to take VTE prophylaxis
16. Pregnant or lactating females
17. Uncontrolled intercurrent illness
18. Any significant medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form
19. Any condition, such as an active, severe infection, or the presence of laboratory
abnormalities, which places the subject at unacceptable risk if he/she were to participate
in the study
20. Any condition that confounds the ability to interpret data from the study

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    560 participants

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