Clinical trial · Interventional

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

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

NCT02285062CI-TRIAL-00067374ROBUSTcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lymphoma, Large B-Cell, Diffuse	Lymphoma	ONTOLOGY_EXACT	0.85

Interventions

Interventions (7)

Intervention	Type	Mapped drug	Match
Cyclophosphamide	Drug	Cyclophosphamide	ALIAS
Doxorubicin	Drug	Doxorubicin	ALIAS
lenalidomide	Drug	Lenalidomide	ALIAS
Placebo	Drug	—	UNRESOLVED
prednisone	Drug	Prednisone	ALIAS
Rituximab	Drug	Rituximab	ALIAS
vincristine	Drug	Vincristine	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
R2-CHOP
description
Lenalidomide plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)
interventionNames
1. Drug: lenalidomide
2. Drug: Rituximab
3. Drug: Cyclophosphamide
4. Drug: Doxorubicin
5. Drug: prednisone
6. Drug: vincristine
type
ACTIVE_COMPARATOR
label
R-CHOP
description
Placebo plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)
interventionNames
1. Drug: Placebo
2. Drug: Rituximab
3. Drug: Cyclophosphamide
4. Drug: Doxorubicin
5. Drug: prednisone
6. Drug: vincristine

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

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

References

Publications (3)

BACKGROUNDNowakowski GS, Chiappella A, Witzig TE, Spina M, Gascoyne RD, Zhang L, Flament J, Repici J, Vitolo U. ROBUST: Lenalidomide-R-CHOP versus placebo-R-CHOP in previously untreated ABC-type diffuse large B-cell lymphoma. Future Oncol. 2016 Jul;12(13):1553-63. doi: 10.2217/fon-2016-0130. Epub 2016 Apr 18. PMID 27089170
DERIVEDAlfaifi A, Bahashwan S, Alsaadi M, Ageel AH, Ahmed HH, Fatima K, Malhan H, Qadri I, Almehdar H. Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies. Adv Hematol. 2024 Nov 12;2024:5948170. doi: 10.1155/2024/5948170. eCollection 2024. PMID 39563886
DERIVEDNowakowski GS, Chiappella A, Gascoyne RD, Scott DW, Zhang Q, Jurczak W, Ozcan M, Hong X, Zhu J, Jin J, Belada D, Bergua JM, Piazza F, Mocikova H, Molinari AL, Yoon DH, Cavallo F, Tani M, Yamamoto K, Izutsu K, Kato K, Czuczman M, Hersey S, Kilcoyne A, Russo J, Hudak K, Zhang J, Wade S, Witzig TE, Vitolo U. ROBUST: A Phase III Study of Lenalidomide Plus R-CHOP Versus Placebo Plus R-CHOP in Previously Untreated Patients With ABC-Type Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2021 Apr 20;39(12):1317-1328. doi: 10.1200/JCO.20.01366. Epub 2021 Feb 23. PMID 33621109

Registry

Dates and enrollment

Start: Feb 17, 2015
Primary completion: Mar 15, 2019
Completion: Jul 28, 2022
First posted: Nov 6, 2014
Last update posted: Jun 22, 2023
Results first posted: Mar 30, 2020
Enrollment: 570 (actual)
Lead sponsor: Celgene INDUSTRY
Keywords: 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

Data updated 22 days agoSource updated Jun 22, 2023source: clinicaltrials

Locations

Locations by country (158)

Country	Sites	Recruiting
Italy	29	0
United States	22