Trial Outcomes & Findings for Rituximab to the Preparative Regimen of Etoposide and Total Body Irradiation in Acute Lymphoblastic Leukemia (NCT NCT00427791)
NCT ID: NCT00427791
Last Updated: 2016-05-09
Results Overview
Time from randomization to first progression or death, whichever comes first, measured in months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
2 Years post transplant or until disease progression or death
Results posted on
2016-05-09
Participant Flow
Recruitment Period: July 05, 2005 to August 08, 2008. All participants were enrolled at UT MD Anderson Cancer Center.
Participant milestones
| Measure |
Etoposide + Total Body Irradiation + Rituximab
Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m\^2 IV Weekly Over 4-8 Hours for 4 Weeks
|
Etoposide + Total Body Irradiation
Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
13
|
|
Overall Study
COMPLETED
|
10
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rituximab to the Preparative Regimen of Etoposide and Total Body Irradiation in Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Etoposide + Total Body Irradiation + Rituximab
n=10 Participants
Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m\^2 IV Weekly Over 4-8 Hours for 4 Weeks
|
Etoposide + Total Body Irradiation
n=13 Participants
Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 Years post transplant or until disease progression or deathPopulation: Analysis was by protocol. Participants were randomized between Etoposide + Total body irradiation and Etoposide + Total body irradiation + Rituximab using a Bayesian adaptive algorithm.
Time from randomization to first progression or death, whichever comes first, measured in months.
Outcome measures
| Measure |
Etoposide + Total Body Irradiation + Rituximab
n=10 Participants
Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m\^2 IV Weekly Over 4-8 Hours for 4 Weeks
|
Etoposide + Total Body Irradiation
n=13 Participants
Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
|
|---|---|---|
|
Progression-free Survival (PFS)
|
4.3 Months
Standard Deviation 0.95 • Interval 1.0 to 10.0
|
14.5 Months
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: During the first 100 days following transplantPopulation: Analysis was by protocol.
Number of participants with incidence of acute graft versus host disease (aGVHD) during first 100 days following transplant.
Outcome measures
| Measure |
Etoposide + Total Body Irradiation + Rituximab
n=10 Participants
Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m\^2 IV Weekly Over 4-8 Hours for 4 Weeks
|
Etoposide + Total Body Irradiation
n=13 Participants
Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
|
|---|---|---|
|
Number of Participants With Incidence of Acute Graft Versus Host Disease During First 100 Days
|
5 participants
|
9 participants
|
Adverse Events
Etoposide + Total Body Irradiation + Rituximab
Serious events: 10 serious events
Other events: 10 other events
Deaths: 0 deaths
Etoposide + Total Body Irradiation
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etoposide + Total Body Irradiation + Rituximab
n=10 participants at risk
Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m\^2 IV Weekly Over 4-8 Hours for 4 Weeks
|
Etoposide + Total Body Irradiation
n=13 participants at risk
Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
|
|---|---|---|
|
Cardiac disorders
Hypertension
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/13 • 3 years
|
|
Cardiac disorders
Hypotension
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/13 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/13 • 3 years
|
|
Gastrointestinal disorders
Mucositis
|
50.0%
5/10 • Number of events 5 • 3 years
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
GI Pain
|
0.00%
0/10 • 3 years
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Acute renal failure
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/13 • 3 years
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
2/10 • Number of events 2 • 3 years
|
0.00%
0/13 • 3 years
|
|
Hepatobiliary disorders
Transiminitis
|
10.0%
1/10 • Number of events 1 • 3 years
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Hepatobiliary disorders
Venous occlusive disease
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/13 • 3 years
|
|
Nervous system disorders
Other (Pain)
|
20.0%
2/10 • Number of events 2 • 3 years
|
0.00%
0/13 • 3 years
|
|
Investigations
Pneumonitis
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/13 • 3 years
|
Other adverse events
| Measure |
Etoposide + Total Body Irradiation + Rituximab
n=10 participants at risk
Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m\^2 IV Weekly Over 4-8 Hours for 4 Weeks
|
Etoposide + Total Body Irradiation
n=13 participants at risk
Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
|
|---|---|---|
|
Cardiac disorders
Edema
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/13 • 3 years
|
|
Cardiac disorders
Hypertension
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/13 • 3 years
|
|
General disorders
Fever
|
20.0%
2/10 • Number of events 2 • 3 years
|
23.1%
3/13 • Number of events 3 • 3 years
|
|
General disorders
Lethargy
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/13 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
90.0%
9/10 • Number of events 9 • 3 years
|
69.2%
9/13 • Number of events 9 • 3 years
|
|
Gastrointestinal disorders
Mucositis
|
30.0%
3/10 • Number of events 3 • 3 years
|
69.2%
9/13 • Number of events 9 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
60.0%
6/10 • Number of events 6 • 3 years
|
53.8%
7/13 • Number of events 7 • 3 years
|
|
Gastrointestinal disorders
GvHD
|
0.00%
0/10 • 3 years
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/10 • 3 years
|
15.4%
2/13 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
5/10 • Number of events 5 • 3 years
|
69.2%
9/13 • Number of events 9 • 3 years
|
|
Renal and urinary disorders
Hemorrhagic cystitis
|
0.00%
0/10 • 3 years
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
60.0%
6/10 • Number of events 6 • 3 years
|
38.5%
5/13 • Number of events 5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
10.0%
1/10 • Number of events 1 • 3 years
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/10 • 3 years
|
23.1%
3/13 • Number of events 3 • 3 years
|
|
General disorders
Bone pain
|
0.00%
0/10 • 3 years
|
15.4%
2/13 • Number of events 2 • 3 years
|
|
Nervous system disorders
Neuropathy
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/13 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/10 • 3 years
|
7.7%
1/13 • Number of events 1 • 3 years
|
|
Infections and infestations
Infection
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/13 • 3 years
|
|
General disorders
Neurologic
|
20.0%
2/10 • Number of events 2 • 3 years
|
53.8%
7/13 • Number of events 7 • 3 years
|
Additional Information
Dr. Partow Kebriaei, Associate Professor
UT MD Anderson Cancer Center
Phone: 713-792-2648
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place