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A Randomized Phase II Trial of Rituximab Versus Lenalidomide (REVLIMID™, Cc-5013) (IND#73034) Versus Rituximab + Lenalidomide in Recurrent Follicular Non-Hodgkin Lymphoma (NHL) That is Not Rituximab-Refractory


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Randomized Phase II Trial of Rituximab Versus Lenalidomide (REVLIMID™, Cc-5013) (IND#73034) Versus Rituximab + Lenalidomide in Recurrent Follicular Non-Hodgkin Lymphoma (NHL) That is Not Rituximab-Refractory


Outline:

This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
Please see the "Arms" section for a description of each treatment arm. The primary and
secondary objectives of the study are provided below.

Primary Objectives:

- To determine the response rate (overall and complete) after lenalidomide therapy and
rituximab + lenalidomide in follicular NHL patients who have relapsed.

- To determine time to progression after lenalidomide therapy and rituximab and
lenalidomide in follicular NHL patients who have relapsed.

Secondary Objectives:

- To compare the time to progression of the previous rituximab regimen to that obtained
subsequently to lenalidomide therapy and rituximab + lenalidomide.

- To determine the toxicity profile of lenalidomide therapy and of rituximab and
lenalidomide in follicular NHL patients who have received a previous rituximab regimen.

- To correlate Fc receptor polymorphism profiling with response to lenalidomide or
rituximab + lenalidomide in previously treated patients with follicular NHL who have
relapsed.

- To evaluate changes in Natural Killer (NK) cells, activated NK cells, activated T-cells
and several plasma cytokines followed by rituximab therapy and correlation of observed
changes to objective response rates.

After completion of study treatment, patients are followed for up to 10 years from study
entry.

Inclusion Criteria


- Documentation of Disease

- Previously treated, histologically confirmed follicle center cell lymphoma,
World Health Organization (WHO) classification, grade 1, 2, or 3a

- Institutional flow cytometry or immunohistochemistry must confirm Cluster of
Differentiation 20 (CD20) antigen expression.

- Prior Treatment

- Patient must have been treated with rituximab either alone or in combination
with chemotherapy.

- Patient must have a time to progression of ≥ 6 months from last rituximab dose.

- No corticosteroids within two weeks prior to study, except for maintenance
therapy for a non-malignant disease. Maintenance therapy dose may not exceed 20
mg/day prednisone or equivalent.

- No prior radioimmunotherapy within 12 months of study entry.

- Age ≥ 18 years.

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

- Measurable disease must be present either on physical examination or imaging studies.
Non-measurable disease alone is not acceptable. Any tumor mass >1 cm is
acceptable.Lesions that are considered non-measurable include the following:

- Bone lesions

- Ascites

- Pleural/pericardial effusion

- Lymphangitis cutis/pulmonis

- Bone marrow

- No known Central Nervous System (CNS) involvement by lymphoma.

- No known Human Immunodeficiency Virus (HIV) infection.

- Non-pregnant and non-nursing.

- Patients with a "currently active" second malignancy, other than non-melanoma skin
cancers, are not eligible.

- Patients with a recent history (within 3 months of study entry) of Deep Vein
Thrombosis/Pulmonary Embolism (DVT/PE) are not eligible.

- Required Initial Laboratory Values:

- Absolute Neutrophil Count (ANC) ≥ 1000/µL

- Platelet count ≥ 75,000/µL

- Creatinine < 1.5 x Upper Limit of Normal (ULN) unless attributed to lymphoma or
calculated clearance > 50 mL/min (patients on dialysis are not eligible)

- Total Bilirubin ≤ 2 x ULN unless attributed to lymphoma or Gilbert's disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (overall and complete) at 2, 4, 6, 9, 12, 15, 18, and 24 months, and then yearly for up to 10 years

Outcome Time Frame:

Up to 10 years

Safety Issue:

No

Principal Investigator

John P. Leonard, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000442872

NCT ID:

NCT00238238

Start Date:

March 2006

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - GreenvilleGreenville, South Carolina  29615
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Kaiser Permanente Medical Office -Vandever Medical OfficeSan Diego, California  92120
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana  46815
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Mountainview MedicalBerlin, Vermont  05602
Danville Regional Medical CenterDanville, Virginia  24541
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Menorah Medical CenterOverland Park, Kansas  66209
Saint Luke's Hospital - SouthOverland Park, Kansas  66213
St. Joseph Medical CenterKansas City, Missouri  64114
Heartland Hematology Oncology Associates, IncorporatedKansas City, Missouri  64118
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Liberty HospitalLiberty, Missouri  64068
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Saint Joseph Oncology, IncorporatedSaint Joseph, Missouri  64507
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Kinston Medical SpecialistsKinston, North Carolina  28501
Greenville Hospital Cancer CenterGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Grove CommonsGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Faris RoadGreenville, South Carolina  29605
Cancer Centers of the Carolinas - Greer Medical OncologyGreer, South Carolina  29650
Cancer Centers of the Carolinas - SenecaSeneca, South Carolina  29672
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Lakes Region General HospitalLaconia, New Hampshire  03246
Galesburg Clinic, PCGalesburg, Illinois  61401
Illinois CancerCare - BloomingtonBloomington%, Illinois  61701
Illinois CancerCare - CantonCanton, Illinois  61520
Illinois CancerCare - CarthageCarthage, Illinois  62321
Illinois CancerCare - EurekaEureka, Illinois  61530
Illinois CancerCare - GalesburgGalesburg, Illinois  61401
Illinois CancerCare - HavanaHavana, Illinois  62644
Illinois CancerCare - Kewanee ClinicKewanee, Illinois  61443
Illinois CancerCare - MacombMacomb, Illinois  61455
Illinois CancerCare - MonmouthMonmouth, Illinois  61462
Illinois CancerCare - Community Cancer CenterNormal, Illinois  61761
Illinois CancerCare - PekinPekin, Illinois  61603
Illinois CancerCare - PeruPeru, Illinois  61354
Illinois CancerCare - PrincetonPrinceton, Illinois  61356
Illinois CancerCare - Spring ValleySpring Valley, Illinois  61362
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer CareConcord, New Hampshire  03301
New Hampshire Oncology - Hematology, PA - HooksettHooksett, New Hampshire  03106
Cancer Centers of the Carolinas - EasleyEasley, South Carolina  29640
Self Regional Cancer Center at Self Regional Medical CenterGreenwood, South Carolina  29646