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A Phase II Trial of Bortezomib (NSC #681239) + Lenalidomide (Revlimid ™, CC-5013) (NSC #703813) for Relapsed/Refractory Mantle Cell Lymphoma


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

Thank you

Trial Information

A Phase II Trial of Bortezomib (NSC #681239) + Lenalidomide (Revlimid ™, CC-5013) (NSC #703813) for Relapsed/Refractory Mantle Cell Lymphoma


PRIMARY OBJECTIVES:

I. To determine the overall response (complete response [CR] and partial response) rate and
the CR rate to bortezomib + lenalidomide therapy in patients with relapsed or refractory
mantle cell lymphoma.

SECONDARY OBJECTIVES:

I. To determine the time to progression after therapy with bortezomib + lenalidomide therapy
in patients with relapsed or refractory mantle cell lymphoma.

II. To determine the disease-free and overall survival after therapy with bortezomib +
lenalidomide therapy in patients with relapsed or refractory mantle cell lymphoma.

OUTLINE:

Patients receive induction therapy comprising bortezomib intravenously (IV) over 3-5 seconds
on days 1, 4, 8, and 11 and lenalidomide orally (PO) once daily on days 1-14. Treatment
repeats every 21 days for up to 8 courses in the absence of disease progression or
unacceptable toxicity. Patients achieving a complete or partial response as best response
after completion of induction therapy receive maintenance therapy comprising bortezomib IV
on days 1 and 8 and lenalidomide PO once daily on days 1-14. Treatment repeats every 21 days
for up to 6 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.


Inclusion Criteria:



- Histologically confirmed mantle cell lymphoma meeting the following criteria:

- Diagnosis confirmed by initial biopsy or at time of relapse

- No bone marrow biopsy as sole means of diagnosis

- May be used in conjunction with nodal biopsies

- No fine needle aspirates

- CD5-positive, CD23-negative, and cyclin D1-positive by flow cytometry or
immunohistochemistry

- Measurable disease, defined as any tumor mass > 1cm by physical examination, CT scan,
MRI, or conventional radiograph

- No nonmeasurable disease only, including any of the following:

- Bone lesions (should be noted, if present)

- Ascites

- Pleural or pericardial effusion

- Lymphangitis cutis or pulmonis

- Bone marrow (involvement by non-Hodgkin lymphoma should be noted)

- Received prior therapy with at least 1 regimen, which may have been single- or
multi-agent, and consisted of traditional cytotoxic and/or biologic agents

- Must have progressive or refractory disease following initial regimen

- Refractory disease defined as stable or progressive disease as best
response to prior therapy, or complete or partial response as initial
response followed by disease progression within 6 months

- No known CNS involvement by lymphoma

- ECOG performance status 0-2

- ANC ≥ 1,000/μL (≥ 500/μL if marrow involvement)

- Platelet count ≥ 75,000/μL

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

- Creatinine ≤ 1.5 times ULN (unless attributable to non-Hodgkin lymphoma) AND
estimated creatinine clearance ≥ 30 mL/min (patients on dialysis are not eligible)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile women must use effective double-barrier contraception during and for at least
28 days after completion of lenalidomide therapy

- Men must use effective contraception during and for 28 days after completion of
lenalidomide therapy, even if they have undergone a successful vasectomy

- No peripheral neuropathy ≥ grade 3 within the past month

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

- CD4-positive cell count > 350/mm^3

- Must have treatment-sensitive HIV and, if on anti-HIV therapy, HIV viral load <
50 copies/mm^3

- No history of AIDS-defining conditions or other HIV-related illnesses

- No concurrent zidovudine or stavudine because of overlapping toxicities with
protocol therapy

- No deep vein thrombosis (DVT) and/or pulmonary embolism (PE) within the past 3 months
* Patients with a distant history (> 3 months prior to study entry) of DVT/PE are
eligible, provided they receive concurrent prophylactic aspirin or low molecular
weight heparin, unless contraindicated

- LVEF ≥ 45% by MUGA scan or ECHO

- No New York Heart Association class III or IV congestive heart failure

- No myocardial infarction within the past 6 months

- No known positivity for hepatitis A, B, or C

- No concurrent dexamethasone or other steroidal antiemetics

- No concurrent hormones used as chemotherapy or other chemotherapeutic agents except
for steroids given for adrenal failure (hormones administered for non-disease related
conditions [e.g., insulin for diabetes or birth control pills])

- No prior bortezomib or lenalidomide

- Prior autologous stem cell transplantation (SCT) allowed

- No prior allogeneic SCT allowed

- No prior radioimmunotherapy within the past 12 months

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

- Maintenance therapy dose may not exceed20 mg/day prednisone or equivalent

- No other concurrent investigational or commercial agents or therapies for lymphoma

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate defined as complete response and partial response

Outcome Description:

Estimated using the uniformly minimum unbiased estimator. Jennison and Turnbull's method will be used to obtain 90% exact confidence interval. Summarized using frequency tables.

Outcome Time Frame:

Assessed up to 6 years

Safety Issue:

No

Principal Investigator

Vicki Morrison

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00483

NCT ID:

NCT00553644

Start Date:

November 2007

Completion Date:

Related Keywords:

  • Recurrent Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Washington University School of MedicineSaint Louis, Missouri  63110
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Eastern Maine Medical CenterBangor, Maine  04401
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Southern California Permanente Medical GroupDowney, California  90242
Munson Medical CenterTraverse City, Michigan  49684
Brigham and Women's HospitalBoston, Massachusetts  02115
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 Cottage HospitalGalesburg, Illinois  61401
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
Valley Cancer CenterSpring Valley, Illinois  61362
Mecosta County Medical CenterBig Rapids, Michigan  49307
Mountainview MedicalBerlin, Vermont  05602
Eureka HospitalEureka, Illinois  61530
Graham Hospital AssociationCanton, Illinois  61520
Pekin HospitalPekin, Illinois  61554
Harold Alfond Center for Cancer CareAugusta, Maine  04330
Union Hospital of Cecil CountyElkton MD, Maryland  21921
McLeod Regional Medical CenterFlorence, South Carolina  29501
Metro Health HospitalGrand Rapids, Michigan  49506
Newton-Wellesley HospitalNewton, Massachusetts  02462
Kaiser Permanente Medical CenterVallejo, California  94589
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
University Of VermontBurlington,, Vermont  05403
Kaiser PermanenteSacramento, California  
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Lombardi Comprehensive Cancer Center at Georgetown UniversityWashington, District of Columbia  20057
Intercommunity Cancer CenterGalesburg, Illinois  61401
Hopedale Medical Complex - HospitalHopedale, Illinois  61747
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
Saint Margaret's HospitalSpring Valley, Illinois  61362
Hematology Oncology Associates-Quad CitiesBettendorf, Iowa  52722
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Saint Mary's Health CareGrand Rapids, Michigan  49503
Spectrum Health at Butterworth CampusGrand Rapids, Michigan  49503
Mercy Health Partners-Mercy CampusMuskegon, Michigan  49443
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
Kinston Medical Specialists PAKinston, North Carolina  28501
University of Missouri - Ellis FischelColumbia, Missouri  65203
Veterans AdministrationColumbia, Missouri  65201
University of Minnesota Medical Center-FairviewMinneapolis, Minnesota  55455
Kaiser Anaheim Medical CenterAnaheim, California  92807
Kaiser Permanente Medical Group - Baldwin ParkBaldwin Park, California  91706
Kaiser Foundation HospitalBellflower, California  90706
Kaiser Permanente HospitalFontana, California  92335
Kaiser Permanente - Harbor CityHarbor City, California  90710
Kaiser Permanente-West Los AngelesLos Angeles, California  90034
Kaiser Permanente - Panorama CityPanorama City, California  91402
Kaiser Permanente at San DiegoSan Diego, California  92120
Kaiser Permanente Health CareSan Marcos, California  92069
Kaiser Permanente-MissionSan Diego, California  92108
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
Bronson Battle CreekBattle Creek, Michigan  49017