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Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00940342
First received: July 14, 2009
Last updated: February 1, 2016
Last verified: February 2016

July 14, 2009
February 1, 2016
August 2004
August 2017   (final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: Blood tests once a week during 8 weeks of treatment. ] [ Designated as safety issue: No ]
Bayesian design based on predictive probability implemented. This design allows for early stopping if data indicates that the treatment is ineffective. The stopping boundary is chosen by computing the predictive probability from observed data. Trial is stopped if the current data indicates that, by the end of each trial, the overall response rate in patients treated with rituximab plus GM-CSF to be higher than P0 (0.15 for group 1 and 0.30 for groups 2 and 3) is very unlikely.
Overall Response Rate [ Time Frame: Blood tests once a week during 8 weeks of treatment. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00940342 on ClinicalTrials.gov Archive Site
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Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia
Rituximab In Combination With Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia (CLL)
The goal of this clinical research study is to learn if giving granulocyte-macrophage colony-stimulating factor (GM-CSF) together with rituximab can improve the ability of rituximab to shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). The safety of this combination treatment will also be studied.

GM-CSF is a drug designed to stimulate the immune system. It will increase the number of a certain type of blood cell called neutrophils and macrophages.

Rituximab is a drug designed to bind to a protein, called CD20, that is on the surface of the leukemia cells, allowing the leukemia cells to be destroyed by the immune system.

Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam, including routine blood tests (about 2 tablespoons). A bone marrow aspirate will be collected. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Imaging studies (such as a chest x-ray or CT scans) may be performed. Women who are able to have children must have a negative blood pregnancy test.

If you are found to be eligible to take part in this study, you will receive GM-CSF as an injection under the skin, three times a week for eight weeks. You will receive rituximab by vein, once a week for four weeks. Usually, the first dose of rituximab requires several hours to complete. Later doses should usually be shorter, but may vary according to individual tolerance. Acetaminophen (Tylenol), diphenhydramine hydrochloride (Benadryl), and steroids (hydrocortisone or similar) will be given before rituximab to decrease the risk of side effects. If side effects do occur during the infusion, you will need to stay at the hospital and be observed until the side effects have gone away. Other than that, treatment will be given on an outpatient basis.

During treatment you will have routine blood tests (about 1 tablespoon) once a week. The treatment will take about 8 weeks to be completed. You will be taken off study if your disease gets worse or if the side effects become too severe.

After treatment is over, you will have a complete physical exam, including routine blood tests (about 2 tablespoons). A bone marrow sample will be taken. Imaging studies (such as a chest x-ray or CT scans) may be repeated to evaluate the effect of the treatment. If this treatment has worked for you, your doctor may advise you to receive it again for a second time.

You will then return for post-treatment evaluation every 6 months for 1 year and then once a year for 3 years or until you start a new treatment.

This is an investigational study. GM-CSF and rituximab have been approved by the FDA for clinical use. Their use together in this study, however, is experimental. Up to 130 patients may take part in this study. All patients will be enrolled at M.D. Anderson Cancer Center.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia
  • Drug: GM-CSF (Sargramostim)
    250 mcg injection under the skin, three times a week for eight weeks.
    Other Names:
    • Sargramostim
    • Leukine
  • Drug: Rituximab
    375 mg/m^2 administered intravenously once weekly for four weeks
    Other Name: Rituxan
  • Experimental: Treated and Relapsed - Group 1
    Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.
    Interventions:
    • Drug: GM-CSF (Sargramostim)
    • Drug: Rituximab
  • Experimental: Treated and High-Risk for Progression - Group 2
    Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.
    Interventions:
    • Drug: GM-CSF (Sargramostim)
    • Drug: Rituximab
  • Experimental: 70 Years of Age and Refused Chemo - Group 3
    Participants receive one (1) course of therapy. One course of therapy consists of four (4) doses of Rituximab 375 mg/m2, administered once weekly by vein for 4 weeks along with GM-CSF 250 mcg subcutaneously three times weekly for 8 weeks.
    Interventions:
    • Drug: GM-CSF (Sargramostim)
    • Drug: Rituximab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
130
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August 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Group 1. Diagnosis of previously treated B-CLL Rai III-IV or earlier stage disease with evidence of "active disease" as defined by the NCI-sponsored working group 1) weight loss of >10% in prior 6 months, 2) extreme fatigue, 3) fever or night sweats without evidence of infection, 4) worsening anemia or thrombocytopenia, 5) progressive lymphocytosis with a rapid lymphocyte doubling time, 6) marked hypogammaglobulinemia or paraproteinemia, 7) lymphadenopathy >5 cm in diameter.
  2. Group 2. Diagnosis of previously untreated B-CLL with Rai stage 0-II disease but high risk for progression based on B2-microglobulin >3.0 mg/mL, or with symptoms or significant fatigue.
  3. Group 3. Patients age 70 years of age and older with previously untreated B-CLL and Rai stage III-IV or earlier stage disease with indication for treatment who refused chemotherapy.
  4. Age 15 years or above.
  5. Adequate renal and hepatic functions (creatinine <2.5 mg/dL, bilirubin <2 mg/dL). Patients with renal or liver dysfunction due to organ infiltration by lymphocytes are eligible, as are patients with elevated bilirubin and history consistent with Gilbert's disease.
  6. Performance status <3 (Zubrod Scale).
  7. No active viral hepatitis

Exclusion Criteria:

1) None.

Both
15 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00940342
2004-0102, NCI-2012-01670
No
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M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Bayer
Principal Investigator: Alessandra Ferrajoli, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP