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Phase II Trial of Increased Dose Rituximab Plus Maintenance Rituximab for Initial Systemic Treatment of Indolent B-Cell Lymphomas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
B-cell Lymphoma, Indolent B-cell Lymphoma

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Trial Information

Phase II Trial of Increased Dose Rituximab Plus Maintenance Rituximab for Initial Systemic Treatment of Indolent B-Cell Lymphomas


- All participants will receive increased-dose rituximab through a vein in the arm once a
week for 4 weeks (on Days 1, 8, 15, and 22 of the initial 28-day study cycle). This
first cycle of study treatment is called the Induction Phase. If the participant
responds well to the Induction Phase, they then may continue to the Maintenance Therapy
Phase, where they will receive a lower dose of rituximab once every three months for up
to 2 years.

- During the Induction Phase, the following procedures will take place before the
participant receives each dose of rituximab: medical review, physical exam,
performance status, and ECG. Blood tests will be drawn about 30-60 minutes after the
first dose of rituximab on Day 1. Samples will be drawn immediately before each dose
and again 30-60 minutes after each dose on Days 1, 8, 15 and 22.

- During the Maintenance Therapy Phase, the following procedures will take place before
the participant receives each dose of rituximab: medical review, physical exam,
performance status, ECG, blood tests and response assessments by CT scan.


Inclusion Criteria:



- Indolent B-Cell NHL of the following histologies:

1. Follicular lymphoma (grades 1-3A);

2. marginal zone lymphoma (extranodal, nodal or splenic):

- Extranodal marginal zone lymphomas (MALT lymphomas) may not be candidates
for cure with antibiotics or local radiotherapy. Patients who have failed
antibiotics or local therapy are eligible for the protocol as long as they
have measurable disease and are naive to chemotherapy and monoclonal
antibody;

- splenic marginal zone lymphoma patients may have received prior splenectomy
as long as they have measureable disease and are naive to chemotherapy and
monoclonal antibody therapy;

3. Small lymphocytic lymphoma (must have less than 5000 circulating clonal
B-lymphocytes);

4. Indolent CD20+ B-cell lymphoma not otherwise specified with CD20+ expression

- Measurable disease, defined as at least one lesion that can be accurately measured in
at least one dimension (longest diameter to be recorded) as 20mm or greater with
conventional techniques or as 10mm or greater with spiral CT scan

- No previous chemotherapy, antibody therapy or radioimmunotherapy for NHL. Patients
previously treated with external bean radiation alone, surgery, or with antibiotics
are eligible

- 18 years of age or older

- Life expectancy of greater than 3 months

- ECOG performance status of 2 or less

- Adequate bone marrow function

- Use of adequate contraception

Exclusion Criteria:

- Prior chemotherapy, monoclonal antibody therapy or radioimmunotherapy for lymphoma

- Receiving any other investigational agent

- Known brain metastases

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to rituximab

- HIV positivity

- Active hepatitis B infection

- Candidate for curative radiotherapy, unless radiation therapy is considered too toxic
(as in abdominal disease), or is refused by the patient

- NYHA Classification III or IV disease

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection that is not optimally treated with antibiotics, unstable angina pectoris,
or psychiatric illness/social situations that would limit compliance with study
requirements

- Pregnant women

- Individuals with a history of a different malignancy except for the following
circumstances:

1. disease-free for at least 1 year and are deemed by the investigator to be at low
risk for recurrence of that malignancy;

2. localized prostate cancer, prostate cancer with elevated PSA but no measurable
disease on CT scans or bone scan, cervical cancer in situ; and

3. non-melanoma skin cancers

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine complete response rate of increased dose rituximab in indolent B-cell lymphomas

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Jeremy Abramson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

09-054

NCT ID:

NCT00895661

Start Date:

July 2009

Completion Date:

December 2013

Related Keywords:

  • B-Cell Lymphoma
  • Indolent B-cell Lymphoma
  • rituximab
  • Lymphoma
  • Lymphoma, B-Cell

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617