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Rituximab +/- Bevacizumab in the Treatment of Patients With Follicular Non-Hodgkin's Lymphoma: A Randomized, Phase II Trial


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

Thank you

Trial Information

Rituximab +/- Bevacizumab in the Treatment of Patients With Follicular Non-Hodgkin's Lymphoma: A Randomized, Phase II Trial


Upon determination of eligibility, patients will randomly be assigned to one of two
treatment arms:

- Rituximab

- Rituximab + bevacizumab

For every 2 patients randomized, 1 will receive treatment number 1 (rituximab), and 1
patient will receive treatment number 2 (rituximab + bevacizumab). This is not a blinded
study, so both the patient and doctor will know which treatment has been assigned.


Inclusion Criteria:



To be included in the study, you must meet the following criteria:

- Follicular NHL, grades 1 or 2 confirmed by a biopsy sample

- 18 years of age or older

- Evidence of disease progression at time of study entry

- Must have had at least one previous chemotherapy regimen and not more than two
previous chemotherapy regimens.

- Patients who have received previous rituximab are eligible as long as progression
occurred more than six months following completion of previous rituximab therapy.

- Measurable or evaluable disease

- Able to perform activities of daily living without considerable assistance

- Adequate bone marrow, kidney, and liver function

- Signed informed consent obtained prior to initiation of any study-specific procedures
or treatment.

Exclusion Criteria:

You cannot participate in the study if any of the following apply to you:

- Treatment with more than two previous chemotherapy regimens

- Prior treatment with bevacizumab or other similar agents

- Progressive NHL less than 6 months after receiving previous rituximab

- More than 1 prior treatment with investigational agents within 4 weeks prior to
entering this study

- Spread of NHL to brain or nervous system

- History of any other uncontrolled or significant disease or medical condition that
may put them at high risk for treatment complications with these agents

Please note: There are additional inclusion/exclusion criteria. The study center will
determine if you meet all of the criteria. If you do not qualify for the trial, study
personnel will explain the reasons. If you do qualify, study personnel will explain the
trial in detail and answer any questions you may have. You can then decide if you wish to
participate.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

Outcome Description:

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

John D Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI LYM 37

NCT ID:

NCT00193492

Start Date:

September 2005

Completion Date:

December 2013

Related Keywords:

  • Lymphoma, Follicular
  • Lymphoma
  • Bevacizumab
  • Rituximab
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

Florida Hospital Cancer InstituteOrlando, Florida  32804
Northeast Arkansas ClinicJonesboro, Arkansas  72401-3125
Florida Cancer SpecialistsFort Myers, Florida  33901
Northeast Georgia Medical CenterGainesville, Georgia  30501
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Methodist Cancer CenterOmaha, Nebraska  68114
Medical Oncology Associates of AugustaAugusta, Georgia  30901
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Wellstar Cancer ResearchMarietta, Georgia  30060
Oncology Hematology CareCincinnati, Ohio  45242
Graves-Gilbert ClinicBowling Green, Kentucky  42101
Watson Clinic for Cancer ResearchLakeland, Florida  33805
Providence Medical GroupTerre Haute, Indiana  47802
Baptist Hospital EastLouisville, Kentucky  40207
Norton Cancer InstituteLouisville, Kentucky  40207
Hematology Oncology Clinic, LLPBaton Rouge, Louisiana  70809
National Capital Clinical Research ConsortiumBethesda, Maryland  20817
Hematology Oncology Associates of Northern NJMorristown, New Jersey  07960
Berks Hematology Oncology AssociatesWest Reading, Pennsylvania  19611
Chattanooga Oncology Hematology AssociatesChattanooga, Tennessee  37404