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A Two-Arm, Non-Randomized, Multicenter, Phase 2 Study of VELCADE (Bortezomib) in Combination With Rituximab, Cyclophosphamide, and Prednisone With or Without Doxorubicin Followed by Rituximab Maintenance in Patients With Relapsed Follicular Lymphoma.


Phase 2
18 Years
N/A
Not Enrolling
Both
Relapsed Follicular Lymphoma

Thank you

Trial Information

A Two-Arm, Non-Randomized, Multicenter, Phase 2 Study of VELCADE (Bortezomib) in Combination With Rituximab, Cyclophosphamide, and Prednisone With or Without Doxorubicin Followed by Rituximab Maintenance in Patients With Relapsed Follicular Lymphoma.


Inclusion Criteria:



- Male or female patient 18 years of age or older

- Pathological diagnosis of follicular lymphoma (any grade) or marginal zone lymphoma.
Patients with transformed follicular lymphoma are eligible, provided there has
previously been pathologic documentation of follicular lymphoma.

- Documented relapse or progression following prior antineoplastic therapy

- At least 1 measurable tumor mass that is greater than 1.5 cm in the long axis and
greater than 1.0 cm in the short axis that has not been previously irradiated, or has
grown since previous irradiation

- No clinically significant evidence of active central nervous system lymphoma

- Karnofsky performance status (KPS) ≥50 (equivalent to Eastern Cooperative Group
Oncology Group [ECOG] status ≤2)

Exclusion Criteria:

- Diagnosed or treated for a malignancy other than Non-Hodgkin's Lymphoma (NHL) within
2 years of first dose, or who were previously diagnosed with a malignancy other than
NHL and have any radiographic or biochemical marker evidence of malignancy. Patients
with prostate cancer who were treated with definitive radiotherapy who have a serum
prostate-specific antigen <1 ng/mL are not excluded. Patients are not excluded if
they have had basal cell or squamous cell carcinoma of the skin that was completely
resected, or any in situ malignancy that was adequately treated.

- Received any of the following treatments or procedures outside of the specified
timeframes:

- Prior treatment with VELCADE

- Prior treatment with a cumulative dose of doxorubicin of more than 100 mg/m2,
if assigned to Arm A (VELCADE-R-CAP)

- Antineoplastic (including unconjugated therapeutic antibodies and toxin
immunoconjugates), experimental, or radiation therapy within 3 weeks before Day
1 of Cycle 1

- Nitrosoureas within 6 weeks before Day 1 of Cycle 1

- Radioimmunoconjugates within 10 weeks before Day 1 of Cycle 1

- Autologous stem cell transplant within 3 months before Day 1 of Cycle 1, or
prior allogeneic stem cell transplant at any time

- Major surgery within 2 weeks before Day 1 of Cycle 1

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Patients With Complete Response (CR)

Outcome Description:

Disappearance of all evidence of disease assessed by computed tomography (CT) and PET (position-emission tomography) according to the revised International Working Group (IWG) Criteria.

Outcome Time Frame:

30 weeks

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C05012

NCT ID:

NCT00715208

Start Date:

September 2008

Completion Date:

March 2011

Related Keywords:

  • Relapsed Follicular Lymphoma
  • Lymphoma
  • Lymphoma, Follicular

Name

Location

Avera Cancer InstituteSioux Falls, South Dakota  57105
Marshfield ClinicMarshfield, Wisconsin  54449
New York Medical CollegeValhalla, New York  10595
Western Pennsylvania Cancer InstitutePittsburgh, Pennsylvania  15224
Great Plains Regional Medical CenterNorth Platte, Nebraska  69101-6598
Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
Jackson Oncology Associates, PLLCJackson, Mississippi  39202
St. Joseph Mercy HospitalPontiac, Michigan  48341-2985
Temple UniversityPhiladelphia, Pennsylvania  19140
Medical Oncology, LLCBaton Rouge, Louisiana  70808
Northern Utah AssociatesOgden, Utah  84403
Allegheny-Singer Research InstitutePittsburgh, Pennsylvania  15212
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
Gabrail Cancer CenterCanton, Ohio  44718
San Juan Oncology AssociatesFarmington, New Mexico  87401
Hope OncologyRichardson, Texas  75080
Providence Saint Joseph Medical CenterBurbank, California  91505-4866
Kalamazoo Hematology and OncologyKalamazoo, Michigan  49048
Nebraska Hematology-Oncology, PCLincoln, Nebraska  68506
Cancer Care Center, Inc.New Albany, Indiana  47150
NYU Clinical Cancer CenterNew York, New York  10016
Alexian Brothers Hospital NetworkElk Grove Village, Illinois  60007
University of Tennessee Medical CenterKnoxville, Tennessee  37920
Northwest Georgia Oncology Centers, PCMarietta, Georgia  30060
Cancer Center of Central ConnecticutSouthington, Connecticut  
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Purchase Cancer GroupPaducah, Kentucky  42002
Landmark Medical CenterWoonsocket, Rhode Island  02895
Northwest Alabama Center, PCMuscle Shoals, Alabama  35661
Pacific Coast Hematology Oncology Medical GroupFountain Valley, California  92708
Loma Linda U Cancer CenterLoma Linda, California  92354
Desert Hematology Medical Group, Inc.Rancho Mirage, California  92270
Ocala Cancer InstituteOcala, Florida  34471
Southern Illinois Hematology OncologyCentralia, Illinois  62801
Clintell, Inc.Skokie, Illinois  60077
Hutchinson ClinicHutchinson, Kansas  67502
St. Louis Cancer Care, LLPChesterfield, Missouri  63017
Interlakes FoundationRochester, New York  14623
Oklahoma Oncology and Hematology, PCOklahoma City, Oklahoma  73112
Marshall UniversityHuntington, West Virginia  25701
West Virginia University Health Science CenterMorgantown, West Virginia  26505