Trial Outcomes & Findings for GM-CSF and Rituximab After Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkin Lymphoma (NCT NCT00521014)
NCT ID: NCT00521014
Last Updated: 2015-12-22
Results Overview
after autologous stem cell transplantation (ASCT). Disease progression is defined using International Workshop Criteria for non-Hodgkin lymphoma37 and is defined as: 1. ≥ 50% increase in products of diameters of any previously identified abnormal node or nodule AND/OR 2. appearance of any new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
up to 3 years
Results posted on
2015-12-22
Participant Flow
Participant milestones
| Measure |
Relapsed Follicular Lymphoma Patients
Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma GM-CSF: 250 mcg (flat dose) three times per week for 8 weeks, Rituximab: 375 mg/m2/week for 4 weeks, beginning within 3 days after the first dose of GM-CSF
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Relapsed Follicular Lymphoma Patients
Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma GM-CSF: 250 mcg (flat dose) three times per week for 8 weeks, Rituximab: 375 mg/m2/week for 4 weeks, beginning within 3 days after the first dose of GM-CSF
|
|---|---|
|
Overall Study
Inevaluable, not treated
|
1
|
Baseline Characteristics
GM-CSF and Rituximab After Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Relapsed Follicular Lymphoma Patients
n=14 Participants
Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 3 yearsafter autologous stem cell transplantation (ASCT). Disease progression is defined using International Workshop Criteria for non-Hodgkin lymphoma37 and is defined as: 1. ≥ 50% increase in products of diameters of any previously identified abnormal node or nodule AND/OR 2. appearance of any new lesions
Outcome measures
| Measure |
Relapsed Follicular Lymphoma Patients
n=13 Participants
Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
|
|---|---|
|
Progression-free Survival Rate
|
1.759 years
Interval 0.47 to 2.3
|
Adverse Events
Relapsed Follicular Lymphoma Patients
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Relapsed Follicular Lymphoma Patients
n=13 participants at risk
Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
|
|---|---|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Inf norm ANC/gr1/2
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Obstruction, GI- Gallbladder
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Pain - Buttock
|
7.7%
1/13 • Number of events 1
|
Other adverse events
| Measure |
Relapsed Follicular Lymphoma Patients
n=13 participants at risk
Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
|
|---|---|
|
Blood and lymphatic system disorders
ALT, SGPT
|
38.5%
5/13 • Number of events 5
|
|
Blood and lymphatic system disorders
AST, SGOT
|
15.4%
2/13 • Number of events 2
|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Amylase
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
23.1%
3/13 • Number of events 3
|
|
Metabolism and nutrition disorders
Creatinine
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
46.2%
6/13 • Number of events 6
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
13/13 • Number of events 13
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
100.0%
13/13 • Number of events 13
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
13/13 • Number of events 13
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
13/13 • Number of events 13
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
76.9%
10/13 • Number of events 10
|
|
Blood and lymphatic system disorders
Platelets
|
100.0%
13/13 • Number of events 13
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
7.7%
1/13 • Number of events 1
|
Additional Information
Dr. Craig Moskowitz
Memorial Sloan Kettering Cancer Center
Phone: 212-639-7992
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place