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A Phase II Trial of Lenalidomide (Revlimid (TM), CC-5013) (NSC #703813, IND#70116) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma, Contiguous Stage II Grade 3 Follicular Lymphoma, Noncontiguous Stage II Grade 1 Follicular Lymphoma, Noncontiguous Stage II Grade 2 Follicular Lymphoma, Noncontiguous Stage II Grade 3 Follicular Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma

Thank you

Trial Information

A Phase II Trial of Lenalidomide (Revlimid (TM), CC-5013) (NSC #703813, IND#70116) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)


PRIMARY OBJECTIVES:

I. To determine the response rate (overall and complete) to treatment with lenalidomide and
rituximab in patients with follicular non-Hodgkin lymphoma (NHL) who have received no prior
systemic therapy.

II. To determine the time to progression after treatment with lenalidomide and rituximab in
patients with previously untreated CD20+ follicular NHL.

SECONDARY OBJECTIVES:

I. To determine the toxicity profile of this regimen in patients with previously untreated
CD20+ follicular NHL.

II. To establish whether the therapeutic effects of this regimen are sufficiently promising
to warrant evaluation in a subsequent randomized trial (in comparison to rituximab alone).

III. To correlate Fcγ receptor polymorphism profiling with response to treatment with this
regimen in patients with previously untreated follicular NHL.

IV. To determine the impact of lenalidomide on immune parameters in patients with previously
untreated follicular NHL.

V. To determine the impact of lenalidomide on angiogenic parameters in patients with
previously untreated follicular NHL.

VI. To correlate lymphoma-associated macrophages (LAM) and FOXP3, GzB, CD10, MUM1, and BCL2
expression with response to treatment with this regimen in patients with previously
untreated follicular NHL.

VII. To determine whether immune gene signatures previously identified as prognostic factors
in follicular lymphoma can be applied to paraffin-embedded tissues in patients treated with
rituximab, to evaluate microRNA signatures associated with these gene signatures and
outcome, to validate immunohistochemical markers associated with outcome in follicular
lymphoma (CD68 LAMs, FOXP3, CD10, BCL6, FOXP1, MUM1), and to investigate whether markers of
angiogenesis may be of value in the prognosis of follicular NHL.

OUTLINE: This is a multicenter study.

Patients receive oral lenalidomide once daily on days 1-21. Treatment with lenalidomide
repeats every 28 days for 12 courses in the absence of disease progression or unacceptable
toxicity. Patients also receive rituximab IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the
absence of disease progression or unacceptable toxicity.

Blood, plasma, and tissue samples may be collected periodically for correlative studies.

After completion of study treatment, patients are followed up every 4 months for 2 years and
then every 6 months for up to 8 years.


Inclusion Criteria:



- Histologically* confirmed follicular non-Hodgkin lymphoma (NHL)

- WHO grade 1, 2, or 3a (> 15 centroblasts per high-power field with centrocytes
present) disease

- Stage III, IV, or bulky (i.e., single mass ≥ 7 cm in any unidimensional
measurement) stage II disease

- Previously untreated disease

- CD20-antigen expression as confirmed by institutional flow cytometry or IHC

- Low- or intermediate-risk disease by Follicular Lymphoma International Prognostic
Index (FLIPI) (i.e., 0-2 risk factors)

- Measurable disease on either physical examination or imaging studies

- Any tumor mass > 1 cm is allowed

- Non-measurable disease alone is not allowed

- Lesions that are considered non-measurable include, but are not limited to, the
following:

- Bone lesions (lesions if present should be noted)

- Ascites

- Pleural/pericardial effusion

- Lymphangitis cutis/pulmonis

- Bone marrow (involvement by NHL should be noted)

- No known CNS involvement by lymphoma

- ECOG performance status 0-2

- ANC ≥ 1,000/mm^3

- Platelet count ≥ 75,000/mm^3

- Creatinine clearance ≥ 30 mL/min (unless attributable to NHL)

- Total bilirubin ≤ 2 times upper limit of normal (unless attributable to NHL or
Gilbert disease)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use two effective methods of contraception for ≥ 28 days
before, during, and for ≥ 3 months after completion of study treatment

- No history of erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson
syndrome

- No uncontrolled seizures

- No autoimmune disorder requiring active immunosuppression

- Patients with HIV infection are eligible, provided they meet the following criteria:

- No evidence of coinfection with hepatitis B or C

- CD4+ cell count ≥ 400/mm^3

- No evidence of resistant strains of HIV

- If not on anti-HIV therapy, HIV viral load < 10,000 copies HIV RNA/mL

- If on anti-HIV therapy, HIV viral load < 50 copies HIV RNA/mL

- No history of AIDS-defining conditions

- No evidence of active hepatitis B or C infection (i.e., no positive serology for
anti-HBc or anti-HCV antibodies)

- HBV-seropositive patients (HBsAg +) are eligible provided they are closely
monitored for evidence of active HBV infection by HBV DNA testing and receive
suppressive therapy with lamivudine or other HBV suppressive therapy until 6
months after the last dose of rituximab

- No known human anti-chimeric antibody (HACA) positivity

- Not on dialysis

- No other concurrent investigational or non-protocol therapy for lymphoma

- No prior systemic therapy for NHL, including chemotherapy or immunotherapy (e.g.,
monoclonal antibody-based therapy)

- Prior involved-field radiotherapy allowed

- More than 2 weeks since prior corticosteroids, except for maintenance therapy for a
nonmalignant disease

- No concurrent dexamethasone and other steroids as antiemetics

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate

Outcome Description:

The true CR rate and its 95% confidence interval will be estimated for each risk group.

Outcome Time Frame:

At 12 months

Safety Issue:

No

Principal Investigator

Peter Martin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-02047

NCT ID:

NCT01145495

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Contiguous Stage II Grade 1 Follicular Lymphoma
  • Contiguous Stage II Grade 2 Follicular Lymphoma
  • Contiguous Stage II Grade 3 Follicular Lymphoma
  • Noncontiguous Stage II Grade 1 Follicular Lymphoma
  • Noncontiguous Stage II Grade 2 Follicular Lymphoma
  • Noncontiguous Stage II Grade 3 Follicular Lymphoma
  • Stage III Grade 1 Follicular Lymphoma
  • Stage III Grade 2 Follicular Lymphoma
  • Stage III Grade 3 Follicular Lymphoma
  • Stage IV Grade 1 Follicular Lymphoma
  • Stage IV Grade 2 Follicular Lymphoma
  • Stage IV Grade 3 Follicular Lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
Methodist Medical Center of IllinoisPeoria, Illinois  61636
North Shore University HospitalManhasset, New York  11030
Eastern Maine Medical CenterBangor, Maine  04401
Franklin Square Hospital CenterBaltimore, Maryland  21237
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Weill Medical College of Cornell UniversityNew York, New York  10021
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Beebe Medical CenterLewes, Delaware  19958
Memorial HospitalCarthage, Illinois  62321
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Proctor HospitalPeoria, Illinois  61614
Perry Memorial HospitalPrinceton, Illinois  61356
Great Plains Regional Medical CenterNorth Platte, Nebraska  69101-6598
Mountainview MedicalBerlin, Vermont  05602
Eureka HospitalEureka, Illinois  61530
Graham Hospital AssociationCanton, Illinois  61520
Holy Family Medical CenterDes Plaines, Illinois  60016
Saint Joseph Medical CenterJoliet, Illinois  60435
Center for Cancer Care and ResearchSt. Louis, Missouri  63141
Randolph HospitalAsheboro, North Carolina  27203
Harold Alfond Center for Cancer CareAugusta, Maine  04330
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Saint Francis Medical CenterGrand Island, Nebraska  68802
McLeod Regional Medical CenterFlorence, South Carolina  29501
University of North CarolinaChapel Hill, North Carolina  27599
Glens Falls HospitalGlens Falls, New York  12801
University Of VermontBurlington,, Vermont  05403
Virginia Commonwealth UniversityRichmond, Virginia  
Florida HospitalOrlando, Florida  32803
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
Southeast Cancer CenterCape Girardeau, Missouri  63703
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
OSF Saint Francis Medical CenterPeoria, Illinois  61637
Lombardi Comprehensive Cancer Center at Georgetown UniversityWashington, District of Columbia  20057
Community Cancer Center FoundationNormal, Illinois  61761
Illinois CancerCare-Ottawa ClinicOttawa, Illinois  61350
Ottawa Regional Hospital and Healthcare CenterOttawa, Illinois  61350
Pekin Cancer Treatment CenterPekin, Illinois  61554
Illinois Oncology Research Association CCOPPeoria, Illinois  61615
Illinois CancerCare-PeoriaPeoria, Illinois  61615
Illinois Valley HospitalPeru, Illinois  61354
Hematology Oncology Associates-Quad CitiesBettendorf, Iowa  52722
Missouri Baptist Medical CenterSaint Louis, Missouri  63131
Exeter HospitalExeter, New Hampshire  03833
Cooper Hospital University Medical CenterCamden, New Jersey  08103
State University of New York Upstate Medical UniversitySyracuse, New York  13210
Mission Hospitals IncAsheville, North Carolina  28801
Wayne Memorial HospitalGoldsboro, North Carolina  27534
University of IllinoisChicago, Illinois  60612
Illinois CancerCare-BloomingtonBloomington%, Illinois  61701
Illinois CancerCare-CantonCanton, Illinois  61520
Illinois CancerCare-CarthageCarthage, Illinois  62321
Illinois CancerCare-EurekaEureka, Illinois  61530
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
University of Missouri - Ellis FischelColumbia, Missouri  65203
Moses Cone Health System-Regional Cancer CenterGreensboro, North Carolina  27403
East Carolina UniversityGreenville, North Carolina  27858
Annie Penn Memorial HospitalReidsville, North Carolina  27320
Monter Cancer CenterLake Success, New York  11042
Capital Region Medical Center-Goldschmidt Cancer CenterJefferson City, Missouri  65109
Comprehensive Cancer Care PCSaint Louis, Missouri  63141
Walter Reed National Military Medical CenterBethesda, Maryland  20889
Cancer and Leukemia Group BChicago, Illinois  60606
North Shore-LIJ Health System CCOPManhasset, New York  11030
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718