Know Cancer

or
forgot password

Single-Arm, Open-Label, Phase II Trial of Rituximab Plus Sargramostim for the Treatment of Newly Diagnosed Follicular B-Cell Lymphoma in Adults


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

Thank you

Trial Information

Single-Arm, Open-Label, Phase II Trial of Rituximab Plus Sargramostim for the Treatment of Newly Diagnosed Follicular B-Cell Lymphoma in Adults


OBJECTIVES:

Primary

- Determine the safety and efficacy of rituximab and sargramostim (GM-CSF), in terms of
complete response at 12 weeks, in patients with newly diagnosed follicular B-cell
lymphoma.

Secondary

- Determine the overall response rate in patients treated with this regimen.

- Determine the progression-free survival at 3 years in patients treated with this
regimen.

- Determine the adverse event profile of this regimen in these patients.

- Determine the survival of patients treated with this regimen.

- Determine the effect of Fc gamma receptor polymorphism on response rate and time to
progression in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive rituximab IV on days 1, 8, 15, and 22 and sargramostim (GM-CSF)
subcutaneously on days 1, 3, and 5. Treatment with GM-CSF repeats weekly for up to 8 weeks
in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection at baseline for correlative laboratory studies of Fc-gamma
receptor RIIIa 158 polymorphism.

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.


Inclusion Criteria:



1. Patients must have histologically confirmed newly diagnosed follicular B-cell
lymphoma.

2. 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.

3. Patients should not have received prior therapy of any kind for follicular B-cell
lymphoma.

4. 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.

5. ECOG performance status /= 60%).

6. 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) within normal institutional limits OR - creatinine clearance >/= 60 mL/min/1.73 m^2
for patients with creatinine levels above institutional normal

7. Hemoglobin >/= 8.0 gm/dL

8. 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.

9. Ability to understand and the willingness to sign an informed consent document.

Exclusion Criteria:

1. Prior therapy of any kind for follicular B-cell lymphoma.

2. Patients may not be receiving any other investigational agents.

3. 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.

4. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to rituximab or other agents used in the study.

5. 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.

6. 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.

7. Pregnant women are excluded from this study.

8. 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.

9. 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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete response at 3 months

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Nathan Fowler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

MDA-2006-0260

NCT ID:

NCT00411086

Start Date:

November 2006

Completion Date:

Related Keywords:

  • Lymphoma
  • 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 I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I 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
  • Granulocyte-Macrophage Colony Stimulating Factor
  • GM-CSF
  • Rituximab
  • Rituxan
  • Lymphoma
  • Lymphoma, B-Cell

Name

Location

M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009