Rituximab and GM-CSF in Treating Patients With Newly Diagnosed Follicular B-Cell Lymphoma
Single-Arm, Open-Label, Phase II Trial of Rituximab Plus Sargramostim for the Treatment of Newly Diagnosed Follicular B-Cell Lymphoma in Adults
4 other identifiers
interventional
60
1 country
1
Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with GM-CSF may be an effective treatment for follicular B-cell lymphoma. PURPOSE: This phase II trial is studying the side effects and how well giving rituximab together with GM-CSF works in treating patients with newly diagnosed follicular B-cell lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 lymphoma
Started Nov 2006
Longer than P75 for phase_2 lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 11, 2006
CompletedFirst Posted
Study publicly available on registry
December 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
December 5, 2017
CompletedDecember 5, 2017
November 1, 2017
10 years
December 11, 2006
November 3, 2017
November 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Response Rate
Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities \[e.g., lactate dehydrogenase (LDH)\] definitely assignable to NHL. Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.
12 weeks (3 months)
Secondary Outcomes (2)
Median Progression-Free Survival (PFS)
3 years
Overall Response (OR) Rate
3 Months
Study Arms (1)
Rituximab + GM-CSF
EXPERIMENTALRituximab 375 mg/m\^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
Interventions
375 mg/m\^2 By Vein Weekly on Days 1, 8, 15, and 22.
250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
Eligibility Criteria
You may qualify if:
- Patients must have histologically confirmed newly diagnosed follicular B-cell lymphoma.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>/= 20 mm with conventional techniques or as \>/= 10 mm with spiral CT scan.
- Patients should not have received prior therapy of any kind for follicular B-cell lymphoma.
- Age \>/= 18 years. Because no dosing or adverse event data are currently available for the use of rituximab in combination with sargramostim in patients (males or females) \<18 years of age, children are excluded from this study.
- Eastern Cooperative Oncology (ECOG) performance status \</= 2 (Karnofsky \>/= 60%).
- Patients must have normal organ and marrow function as defined below: - leukocytes \>/= 3,000/microL; - absolute neutrophil count \>/= 1,500/microL; - platelets \>/= 100,000/microL; -total bilirubin within normal institutional limits; - AST(SGOT)/ALT(SGPT) \</= 2.5 X institutional upper limit of normal; - creatinine within normal institutional limits OR - creatinine clearance \>/= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
- Hemoglobin \>/= 8.0 gm/dL
- The effects of rituximab and sargramostim on the developing human fetus at the recommended therapeutic doses are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign an informed consent document.
You may not qualify if:
- Prior therapy of any kind for follicular B-cell lymphoma.
- Patients may not be receiving any other investigational agents.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to rituximab or other agents used in the study.
- Rituximab is contraindicated in patients with known anaphylaxis or IgE-mediated hypersensitivity to murine proteins. Sargramostim is contraindicated in patients with excessive leukemic myeloid blasts, with known hypersensitivity to GM-CSF or yeast-derived components of the recombinant, and for concomitant (or within 24 hours ± of) uses with chemotherapy or radiotherapy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study.
- Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions.
- Patients with evidence of active or prior infection of Hepatitis B are excluded. (Note: Persons vaccinated for Hepatitis B who have positive antibodies are not excluded).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
- Bayercollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Research Operations Team, Office of VP Clinical Research
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan Fowler, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2006
First Posted
December 13, 2006
Study Start
November 1, 2006
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
December 5, 2017
Results First Posted
December 5, 2017
Record last verified: 2017-11