Trial Outcomes & Findings for Combination Chemotherapy With or Without Total-Body Irradiation Followed By Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma (NCT NCT00559104)
NCT ID: NCT00559104
Last Updated: 2015-08-11
Results Overview
Event will be recorded if it occurs any time post-transplant, until date of death, last recorded contact, or end-of-study; whichever comes first. Below is reported Progression-free Survival: event is relapse or progression, or death.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Assessed at date of progression post-transplant
Results posted on
2015-08-11
Participant Flow
Participant milestones
| Measure |
TBI-based Conditioning
total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
G-CSF
|
nonTBI-based Conditioning
Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
carmustine
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
G-CSF
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
5
|
|
Overall Study
COMPLETED
|
46
|
5
|
|
Overall Study
NOT COMPLETED
|
9
|
0
|
Reasons for withdrawal
| Measure |
TBI-based Conditioning
total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
G-CSF
|
nonTBI-based Conditioning
Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
carmustine
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
G-CSF
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
9
|
0
|
Baseline Characteristics
Combination Chemotherapy With or Without Total-Body Irradiation Followed By Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Irradiation in Conditioning
n=55 Participants
total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
G-CSF
|
Carmustine in Conditioning
n=5 Participants
Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
carmustine
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
G-CSF
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.2 years
n=5 Participants
|
32.4 years
n=7 Participants
|
42.5 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
60 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
|
22 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
5 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at date of progression post-transplantPopulation: per protocol
Event will be recorded if it occurs any time post-transplant, until date of death, last recorded contact, or end-of-study; whichever comes first. Below is reported Progression-free Survival: event is relapse or progression, or death.
Outcome measures
| Measure |
Irradiation in Conditioning
n=55 Participants
total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
G-CSF
|
Carmustine in Conditioning
n=5 Participants
Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
carmustine
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
G-CSF
|
|---|---|---|
|
Progression
|
22 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Assessed at date of death post-transplantPopulation: per protocol
Event will be recorded if it occurs any time from the date of transplant until the end-of-study date, or the date of last contact, whichever comes first.
Outcome measures
| Measure |
Irradiation in Conditioning
n=55 Participants
total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
G-CSF
|
Carmustine in Conditioning
n=5 Participants
Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
carmustine
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
G-CSF
|
|---|---|---|
|
Mortality
|
19 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Any time after transplantPopulation: per protocol
Patient may be assessed for toxicities any time after transplant, up to death, last contact date, or end-of-study date.
Outcome measures
| Measure |
Irradiation in Conditioning
n=55 Participants
total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
G-CSF
|
Carmustine in Conditioning
n=5 Participants
Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
carmustine
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
G-CSF
|
|---|---|---|
|
Short-term and Long-term Treatment-related Toxicities
|
39 participants
|
1 participants
|
Adverse Events
Irradiation in Conditioning
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Carmustine in Conditioning
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Irradiation in Conditioning
n=55 participants at risk
total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
G-CSF
|
Carmustine in Conditioning
n=5 participants at risk
Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor
carmustine
cyclophosphamide
etoposide
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
G-CSF
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatologic (Skin) (COH)
|
3.6%
2/55 • Number of events 2
|
0.00%
0/5
|
|
Hepatobiliary disorders
Hepatic
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
Mucositis
|
18.2%
10/55 • Number of events 10
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.7%
7/55 • Number of events 7
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
3.6%
2/55 • Number of events 2
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
Packed red blood cell transfusion
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
Platelet transfusion
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Cardiac disorders
Sinus tachycardia
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Ear and labyrinth disorders
External ear inflammation
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
2/55 • Number of events 2
|
0.00%
0/5
|
|
Gastrointestinal disorders
Dry mouth
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
Esophagitis
|
3.6%
2/55 • Number of events 2
|
0.00%
0/5
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Gastrointestinal disorders
Mucositis oral
|
5.5%
3/55 • Number of events 3
|
0.00%
0/5
|
|
Gastrointestinal disorders
Nausea
|
21.8%
12/55 • Number of events 12
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
12.7%
7/55 • Number of events 7
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Chest pain
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
General disorders
Chills
|
3.6%
2/55 • Number of events 2
|
0.00%
0/5
|
|
General disorders
Fatigue
|
7.3%
4/55 • Number of events 4
|
0.00%
0/5
|
|
General disorders
Fever
|
5.5%
3/55 • Number of events 3
|
0.00%
0/5
|
|
General disorders
Irritability
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
General disorders
Oedema NOS
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
General disorders
Pain
|
3.6%
2/55 • Number of events 2
|
0.00%
0/5
|
|
Infections and infestations
Catheter related infection
|
3.6%
2/55 • Number of events 2
|
0.00%
0/5
|
|
Infections and infestations
Infection
|
3.6%
2/55 • Number of events 2
|
0.00%
0/5
|
|
Infections and infestations
Infection NOS
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Infection, Bacterial (COH)
|
3.6%
2/55 • Number of events 2
|
0.00%
0/5
|
|
Infections and infestations
Infection, Fungal (COH)
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Infection, Viral (COH)
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Investigations
Alanine aminotransferase increased
|
1.8%
1/55 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Investigations
Aspartate aminotransferase increased
|
1.8%
1/55 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Hyperbilirubinemia
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Investigations
Laboratory test abnormal
|
1.8%
1/55 • Number of events 2
|
0.00%
0/5
|
|
Investigations
Leukopenia
|
0.00%
0/55
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.00%
0/55
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Weight loss
|
3.6%
2/55 • Number of events 2
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Anorexia
|
3.6%
2/55 • Number of events 2
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.6%
2/55 • Number of events 2
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/55
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.6%
2/55 • Number of events 2
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Nervous system disorders
Headache
|
7.3%
4/55 • Number of events 4
|
0.00%
0/5
|
|
Nervous system disorders
Neurological disorder NOS
|
1.8%
1/55 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Psychiatric disorders
Anxiety
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Psychiatric disorders
Depression
|
7.3%
4/55 • Number of events 4
|
0.00%
0/5
|
|
Renal and urinary disorders
Blood urine present
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.6%
2/55 • Number of events 2
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.5%
3/55 • Number of events 3
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
3.6%
2/55 • Number of events 2
|
20.0%
1/5 • Number of events 1
|
|
Vascular disorders
Flushing
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Vascular disorders
Hypertension
|
1.8%
1/55 • Number of events 1
|
0.00%
0/5
|
|
Vascular disorders
Hypotension
|
9.1%
5/55 • Number of events 5
|
0.00%
0/5
|
Additional Information
Dr. Auayporn Nademanee
City of Hope National Medical Center
Phone: 626-256-4673
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place