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)
2 other identifiers
interventional
130
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 leukemia
Started Oct 2004
Longer than P75 for phase_2 leukemia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 12, 2004
CompletedFirst Submitted
Initial submission to the registry
July 14, 2009
CompletedFirst Posted
Study publicly available on registry
July 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2017
CompletedResults Posted
Study results publicly available
September 19, 2018
CompletedSeptember 19, 2018
February 1, 2018
12.2 years
July 14, 2009
February 26, 2018
September 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
Overall Response Rate - Complete Response (CR) + Partial Response (PR). CR is the absence of Lymphocyte infiltrates on biopsy, \<30% Lymphocytes on Bone Marrow Aspirate, Lymphocytes \< 4,000ul , Hemoglobin \>11.0 g/dl , Platelets \>1000,000/ul, Polymorphonuclear neutrophils (PMN) \>1,500/ul, Liver/Spleen not palpable, Nodes none. PR is \<30% Lymphocytes with residual disease on biopsy for nodular PR, Lymphocytes \>50% decrease, Hemoglobin (un-transfused) \> 11.0 g/dl or \>50% improvement from baseline, Platelets \> 100,000/ul or 50% improvement from baseline, PMN \>1,500 ul or 50% improvement from baseline, Liver/Spleen \>/= 50% decrease, Nodes \>/= 50%.
Blood tests once a week during 8 weeks of treatment.
Study Arms (3)
Treated and Relapsed - Group 1
EXPERIMENTALParticipants 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.
Treated and High-Risk for Progression - Group 2
EXPERIMENTALParticipants 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.
70 Years of Age and Refused Chemo - Group 3
EXPERIMENTALParticipants 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
250 mcg injection under the skin, three times a week for eight weeks.
375 mg/m\^2 administered intravenously once weekly for four weeks
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- 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.
- Age 15 years or above.
- 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.
- Performance status \<3 (Zubrod Scale).
- No active viral hepatitis
You may not qualify if:
- \) None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Bayercollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alessandra Ferrajoli, MD/Professor
- Organization
- The University of Texas MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Alessandra Ferrajoli, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2009
First Posted
July 16, 2009
Study Start
October 12, 2004
Primary Completion
January 5, 2017
Study Completion
January 5, 2017
Last Updated
September 19, 2018
Results First Posted
September 19, 2018
Record last verified: 2018-02