Trial Outcomes & Findings for Thymoglobulin and Total Lymphoid Irradiation for Hematologic Malignancies (NCT NCT00476229)
NCT ID: NCT00476229
Last Updated: 2012-08-07
Results Overview
Defined as the proportions of the patients who are alive at day 100, are without Grade 3-4 Graft Graft-versus-host disease (GVHD), without Grade 4 toxicity (unrelated to infection) and have engrafted. Toxicity grades according to Common Toxicity Criteria (CTC) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline to Day 100, assessment at Day 100
Results posted on
2012-08-07
Participant Flow
Recruitment period: July 14, 2006 to October 15, 2008. All patients were registered at UT MD Anderson Cancer Center.
Participant milestones
| Measure |
Radiation + Chemotherapy + BSCT
Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m\^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Radiation + Chemotherapy + BSCT
Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m\^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
|
|---|---|
|
Overall Study
Progressive shortness of breath
|
1
|
Baseline Characteristics
Thymoglobulin and Total Lymphoid Irradiation for Hematologic Malignancies
Baseline characteristics by cohort
| Measure |
Radiation + Chemotherapy + BSCT
n=20 Participants
Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m\^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
|
|---|---|
|
Age Continuous
|
30 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 100, assessment at Day 100Population: Analysis was per protocol. One participant was inevaluable.
Defined as the proportions of the patients who are alive at day 100, are without Grade 3-4 Graft Graft-versus-host disease (GVHD), without Grade 4 toxicity (unrelated to infection) and have engrafted. Toxicity grades according to Common Toxicity Criteria (CTC) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Outcome measures
| Measure |
Radiation + Chemotherapy + BSCT
n=19 Participants
Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m\^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
|
|---|---|
|
Composite Success Rate
Engraftment
|
100 Percentage of participants
|
|
Composite Success Rate
Acute GvHD
|
75 Percentage of participants
|
|
Composite Success Rate
alive at 100 days
|
84 Percentage of participants
|
Adverse Events
Radiation + Chemotherapy + BSCT
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiation + Chemotherapy + BSCT
n=19 participants at risk
Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m\^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
|
|---|---|
|
Hepatobiliary disorders
increased bilrubin
|
5.3%
1/19 • Number of events 1 • 2 year, 5 months
|
Other adverse events
| Measure |
Radiation + Chemotherapy + BSCT
n=19 participants at risk
Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m\^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
|
|---|---|
|
Gastrointestinal disorders
diarrhea
|
26.3%
5/19 • Number of events 5 • 2 year, 5 months
|
|
Cardiac disorders
low blood pressure
|
36.8%
7/19 • Number of events 7 • 2 year, 5 months
|
|
Cardiac disorders
dysrhythmias
|
5.3%
1/19 • Number of events 1 • 2 year, 5 months
|
|
Cardiac disorders
tachycardia
|
21.1%
4/19 • Number of events 4 • 2 year, 5 months
|
|
Cardiac disorders
edema
|
26.3%
5/19 • Number of events 5 • 2 year, 5 months
|
|
Cardiac disorders
arterial
|
10.5%
2/19 • Number of events 2 • 2 year, 5 months
|
|
Cardiac disorders
other cardiac
|
26.3%
5/19 • Number of events 5 • 2 year, 5 months
|
|
Cardiac disorders
pain
|
10.5%
2/19 • Number of events 2 • 2 year, 5 months
|
|
Cardiac disorders
pericardial
|
5.3%
1/19 • Number of events 1 • 2 year, 5 months
|
|
Endocrine disorders
other endocrine
|
15.8%
3/19 • Number of events 3 • 2 year, 5 months
|
|
General disorders
fatigue
|
36.8%
7/19 • Number of events 7 • 2 year, 5 months
|
|
General disorders
rigors
|
10.5%
2/19 • Number of events 2 • 2 year, 5 months
|
|
General disorders
other general disorders
|
36.8%
7/19 • Number of events 7 • 2 year, 5 months
|
|
General disorders
fever
|
36.8%
7/19 • Number of events 7 • 2 year, 5 months
|
|
Gastrointestinal disorders
nausea
|
47.4%
9/19 • Number of events 9 • 2 year, 5 months
|
|
Gastrointestinal disorders
Gastrointestinal other
|
68.4%
13/19 • Number of events 13 • 2 year, 5 months
|
|
Gastrointestinal disorders
Anorexia
|
5.3%
1/19 • Number of events 1 • 2 year, 5 months
|
|
Renal and urinary disorders
increased creatinine
|
26.3%
5/19 • Number of events 5 • 2 year, 5 months
|
|
Gastrointestinal disorders
bleeding
|
10.5%
2/19 • Number of events 2 • 2 year, 5 months
|
|
Gastrointestinal disorders
vomiting
|
10.5%
2/19 • Number of events 2 • 2 year, 5 months
|
|
Renal and urinary disorders
cystitis
|
15.8%
3/19 • Number of events 3 • 2 year, 5 months
|
|
Gastrointestinal disorders
pain
|
15.8%
3/19 • Number of events 3 • 2 year, 5 months
|
|
Hepatobiliary disorders
increased Alkaline phosphatase
|
36.8%
7/19 • Number of events 7 • 2 year, 5 months
|
|
Hepatobiliary disorders
increased ALT
|
47.4%
9/19 • Number of events 9 • 2 year, 5 months
|
|
Hepatobiliary disorders
increased biblrubin
|
26.3%
5/19 • Number of events 5 • 2 year, 5 months
|
|
Hepatobiliary disorders
increased LDH
|
15.8%
3/19 • Number of events 3 • 2 year, 5 months
|
|
Infections and infestations
infection
|
5.3%
1/19 • Number of events 1 • 2 year, 5 months
|
|
Metabolism and nutrition disorders
hypercalcemia
|
10.5%
2/19 • Number of events 2 • 2 year, 5 months
|
|
Metabolism and nutrition disorders
hyperglycemia
|
42.1%
8/19 • Number of events 8 • 2 year, 5 months
|
|
Metabolism and nutrition disorders
hypermagesium
|
21.1%
4/19 • Number of events 4 • 2 year, 5 months
|
|
Metabolism and nutrition disorders
hypocalcemia
|
5.3%
1/19 • Number of events 1 • 2 year, 5 months
|
|
Metabolism and nutrition disorders
hypokalemia
|
5.3%
1/19 • Number of events 1 • 2 year, 5 months
|
|
Metabolism and nutrition disorders
metabolic other
|
5.3%
1/19 • Number of events 1 • 2 year, 5 months
|
|
Musculoskeletal and connective tissue disorders
motor
|
15.8%
3/19 • Number of events 3 • 2 year, 5 months
|
|
Nervous system disorders
headache
|
47.4%
9/19 • Number of events 9 • 2 year, 5 months
|
|
Musculoskeletal and connective tissue disorders
other neruologic
|
31.6%
6/19 • Number of events 6 • 2 year, 5 months
|
|
Nervous system disorders
insomnia
|
10.5%
2/19 • Number of events 2 • 2 year, 5 months
|
|
Nervous system disorders
neurologic mood
|
21.1%
4/19 • Number of events 4 • 2 year, 5 months
|
|
Eye disorders
eye pain
|
10.5%
2/19 • Number of events 2 • 2 year, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
10.5%
2/19 • Number of events 2 • 2 year, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
26.3%
5/19 • Number of events 5 • 2 year, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
26.3%
5/19 • Number of events 5 • 2 year, 5 months
|
|
Skin and subcutaneous tissue disorders
rash
|
36.8%
7/19 • Number of events 7 • 2 year, 5 months
|
|
Skin and subcutaneous tissue disorders
skin other
|
15.8%
3/19 • Number of events 3 • 2 year, 5 months
|
|
Skin and subcutaneous tissue disorders
alopecia
|
5.3%
1/19 • Number of events 1 • 2 year, 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place