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Rituximab + GM-CSF in Patients With Follicular B-Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT01939730
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : November 4, 2015
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to see if using the drugs Rituximab (IDEC-C2B8) and Granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leukine) together is better than using rituximab alone to treat follicular B-cell lymphomas. The safety of this treatment will also be studied.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Rituximab Drug: GM-CSF Phase 2

Detailed Description:

Rituximab seeks out and helps destroy cancer cells. GM-CSF stimulates the body to produce white blood cells.

Before treatment starts, patients will have a complete exam, including blood and urine tests. A chest x-ray and a CT scan or MRI scan of the abdomen and pelvis will be done to measure tumors. Bone marrow and lymph node samples will be taken.

Women who are able to have children must have a negative blood pregnancy test.

Patients in this study will receive both rituximab and GM-CSF. The combined treatment will last 8 weeks.

Rituximab will be given through a needle in a vein over 3-6 hours once a week. GM-CSF will be given through a needle under the skin 3 times a week. The first of these 3 doses will be usually given 1 hour before the rituximab dose. In selected cases, GM-CSF will start 1 week before or 1 day after the rituximab.

Patients may also receive the drugs acetaminophen (Tylenol) and diphenhydramine hydrochloride (Benadryl) 30-60 minutes before each dose of rituximab. This will be done to ease side effects. Patients may need to stay in the clinic for up to 2 hours after rituximab is given.

If the combined Rituximab and GM-CSF treatment causes severe side effects, the treatment may be stopped.

During the study, blood tests will be done before each rituximab treatment and after the first and fourth rituximab treatments. About 2 to 6 teaspoons of blood will be drawn for each test. A physical exam and a urine test will be done before the fourth rituximab treatment.

After all treatment is done, patients will have a complete exam, including blood tests once a week for 4 weeks and then at 2, 3, 6, 9, 12, 18, and 24 months. A CT scan or MRI scan of the abdomen and pelvis will also be done at 2, 3, 6, 9, 12, 18, and 24 months. Bone marrow samples will be taken at 2, 3, and 12 months. Some patients may also have bone marrow samples taken once a year after that. A large needle will be used to take the bone marrow samples.

This is an investigational study. GM-CSF and rituximab are approved for commercial use by FDA. As many as 40 patients will take part in the study. All will be treated as outpatients. The study will take place only at the University of Texas (UT) MD Anderson Cancer Center (MDACC).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rituximab (IDEC-C2B8) Plus GM-CSF in Patients With Follicular B-Cell Lymphoma
Study Start Date : August 1999
Actual Primary Completion Date : December 2006
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: Rituximab + GM-CSF
All patients receive one (1) course of therapy consisting of four (4) doses of rituximab, a single dose 375 mg/m^2 administered once weekly for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly (tiw) for 8 weeks, starting 1 hour before the first dose of rituximab. In selected cases, the GM-CSF starts 1 week before, or 1 day after, the first rituximab dose.
Drug: Rituximab
375 mg/m^2 by vein once a week for 4 weeks on Days 1, 8, 15, 22.
Other Name: Rituxan

Drug: GM-CSF
250 mcg subcutaneously 3 times a week for 8 weeks.
Other Names:
  • Sagramostim
  • Leukine




Primary Outcome Measures :
  1. Overall Response Rate of Rituximab plus GM-CSF of repeat doses (once weekly times four) [ Time Frame: 1 month ]
    Response Rate is the number of participants with response compared to total. Response definitions: Complete response (CR) defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays. Complete response "unconfirmed" (CRu) defined on the basis of minimal residual abnormalities on x-ray such as a residual mass <25% of original measurement with no palpable disease on physical examination. Partial response (PR) defined as 50-75% reduction in the product of palpable tumor diameters of in the tumor volume measurements by radiologic criteria or any palpable disease such as peripheral node(s) > 1 cm in diameter or palpable abdominal mass with histological evidence of lymphoma cells. Minor response or failure includes <50% tumor shrinkage, or > 50% but with tumor regrowth between courses.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed follicular B-cell lymphoma. This can include relapsed patients, who have had no prior rituximab therapy, or previously untreated patients. Previously untreated patients should be made aware of higher priority protocols such as combination chemo-immunotherapy protocols, but if they decline that, they can be entered on this protocol.
  2. Males or females, 18 years or older; expected survival of =/> 4 months; performance status of 0, 1 or 2.
  3. Demonstrable monoclonal cluster of differentiation antigen 20 (CD20)-positive B-cell population.
  4. Acceptable hematologic status including:

i. hemoglobin (Hgb) =/> 8.0 gm/dL

ii. White blood count (WBC) =/> 3.0 x 10^3/mm^3(x 10^9/L)

iii. Absolute granulocyte count =/> 1.5 x 10^3/mm^3

iv. Platelet count =/>75 x 10^3/mm^3

e. Adequate renal function (serum creatinine ≤ 2mg/dl)

Exclusion Criteria:

  1. presence of Central Nervous System (CNS) Lymphoma
  2. chronic lymphocytic leukemia (CLL)
  3. small lymphocytic lymphoma
  4. therapy in prior 3 weeks (6 weeks for nitrosourea; 6 months for Bone Marrow Transplantation (BMT))
  5. patients who received prior rituximab or other anti-CD20 therapy
  6. serious non-malignant disease, or other malignancy
  7. active infection
  8. history of HIV infection

i pregnancy


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939730


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech, Inc.
Investigators
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Principal Investigator: Felipe Samaniego, MD, MPH, BS M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01939730     History of Changes
Other Study ID Numbers: DM98-304
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: November 2015

Keywords provided by M.D. Anderson Cancer Center:
Lymphoma
Follicular B-Cell Lymphoma
Rituximab
Rituxan
GM-CSF
Sargramostim
Leukine

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Sargramostim
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents