Trial Outcomes & Findings for Chemotherapy Plus Radiation Therapy in Treating Patients With Refractory or Relapsed Hodgkin's Lymphoma (NCT NCT00003631)
NCT ID: NCT00003631
Last Updated: 2016-01-25
Results Overview
Determine the overall objective response. CR rate \[as measured from the start of ICE, (or high dose CTX) to the end of transplant for those who receive it, or the end of ICE for those who do not\].Complete response (CR): No evidence of Hodgkin's disease determined clinically, radiologically or pathologically when indicated
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
118 participants
Primary outcome timeframe
2 years
Results posted on
2016-01-25
Participant Flow
Participant milestones
| Measure |
Group A - Favorable Prognostic Group
|
Group B - Intermediate Prognostic Group
|
Group C - Unfavorable Prognostic Group
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
44
|
24
|
|
Overall Study
COMPLETED
|
47
|
43
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
9
|
Reasons for withdrawal
| Measure |
Group A - Favorable Prognostic Group
|
Group B - Intermediate Prognostic Group
|
Group C - Unfavorable Prognostic Group
|
|---|---|---|---|
|
Overall Study
Patient not treated
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
5
|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Evaluable for toxicity only
|
0
|
0
|
2
|
Baseline Characteristics
Chemotherapy Plus Radiation Therapy in Treating Patients With Refractory or Relapsed Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Group A - Favorable Prognostic Group
n=50 Participants
|
Group B - Intermediate Prognostic Group
n=44 Participants
|
Group C - Unfavorable Prognostic Group
n=24 Participants
|
Total
n=118 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
|
2 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsDetermine the overall objective response. CR rate \[as measured from the start of ICE, (or high dose CTX) to the end of transplant for those who receive it, or the end of ICE for those who do not\].Complete response (CR): No evidence of Hodgkin's disease determined clinically, radiologically or pathologically when indicated
Outcome measures
| Measure |
Group A - Favorable Prognostic Group
n=47 Participants
|
Group B - Intermediate Prognostic Group
n=43 Participants
|
Group C - Unfavorable Prognostic Group
n=15 Participants
|
|---|---|---|---|
|
Objective Response
Failure
|
3 participants
|
6 participants
|
3 participants
|
|
Objective Response
Minor Response (MR)
|
2 participants
|
1 participants
|
0 participants
|
|
Objective Response
Partial Response (PR)
|
1 participants
|
2 participants
|
4 participants
|
|
Objective Response
Progression of Disease (POD)
|
0 participants
|
1 participants
|
0 participants
|
|
Objective Response
Progression Free (P-Free)
|
41 participants
|
31 participants
|
7 participants
|
|
Objective Response
Complete Response (CR)
|
0 participants
|
2 participants
|
1 participants
|
Adverse Events
Group A - Favorable Prognostic Group
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
Group B - Intermediate Prognostic Group
Serious events: 6 serious events
Other events: 44 other events
Deaths: 0 deaths
Group C - Unfavorable Prognostic Group
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A - Favorable Prognostic Group
n=50 participants at risk
|
Group B - Intermediate Prognostic Group
n=44 participants at risk
|
Group C - Unfavorable Prognostic Group
n=24 participants at risk
|
|---|---|---|---|
|
Cardiac disorders
Cardiac ischemia
|
2.0%
1/50 • Number of events 1
|
0.00%
0/44
|
0.00%
0/24
|
|
Infections and infestations
Catheter related infection
|
2.0%
1/50 • Number of events 1
|
2.3%
1/44 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Pneumonitis
|
2.0%
1/50 • Number of events 1
|
4.5%
2/44 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/50
|
2.3%
1/44 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Febrile neutropenia
|
0.00%
0/50
|
4.5%
2/44 • Number of events 2
|
0.00%
0/24
|
|
Infections and infestations
Infection without neutropenia
|
0.00%
0/50
|
4.5%
2/44 • Number of events 2
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Neutrophils
|
0.00%
0/50
|
2.3%
1/44 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary, other
|
0.00%
0/50
|
2.3%
1/44 • Number of events 1
|
0.00%
0/24
|
|
Cardiac disorders
Supravent arrhythmia
|
0.00%
0/50
|
2.3%
1/44 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
Confusion
|
0.00%
0/50
|
0.00%
0/44
|
4.2%
1/24 • Number of events 1
|
|
General disorders
GI, other
|
0.00%
0/50
|
0.00%
0/44
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/50
|
0.00%
0/44
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/50
|
0.00%
0/44
|
4.2%
1/24 • Number of events 1
|
Other adverse events
| Measure |
Group A - Favorable Prognostic Group
n=50 participants at risk
|
Group B - Intermediate Prognostic Group
n=44 participants at risk
|
Group C - Unfavorable Prognostic Group
n=24 participants at risk
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
0.00%
0/50
|
4.5%
2/44 • Number of events 2
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Bilirubin
|
20.0%
10/50 • Number of events 10
|
6.8%
3/44 • Number of events 3
|
16.7%
4/24 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemoglobin (Hgb)
|
92.0%
46/50 • Number of events 46
|
93.2%
41/44 • Number of events 41
|
95.8%
23/24 • Number of events 23
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
42.0%
21/50 • Number of events 21
|
31.8%
14/44 • Number of events 14
|
20.8%
5/24 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.0%
2/50 • Number of events 2
|
6.8%
3/44 • Number of events 3
|
8.3%
2/24 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.0%
4/50 • Number of events 4
|
4.5%
2/44 • Number of events 2
|
20.8%
5/24 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
40.0%
20/50 • Number of events 20
|
27.3%
12/44 • Number of events 12
|
37.5%
9/24 • Number of events 9
|
|
Metabolism and nutrition disorders
Hyponatremia
|
64.0%
32/50 • Number of events 32
|
36.4%
16/44 • Number of events 16
|
33.3%
8/24 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
60.0%
30/50 • Number of events 30
|
56.8%
25/44 • Number of events 25
|
45.8%
11/24 • Number of events 11
|
|
Blood and lymphatic system disorders
Leukocytes
|
92.0%
46/50 • Number of events 46
|
93.2%
41/44 • Number of events 41
|
95.8%
23/24 • Number of events 23
|
|
Blood and lymphatic system disorders
Lymphopenia
|
98.0%
49/50 • Number of events 49
|
97.7%
43/44 • Number of events 43
|
95.8%
23/24 • Number of events 23
|
|
Blood and lymphatic system disorders
Neutrophils
|
92.0%
46/50 • Number of events 46
|
90.9%
40/44 • Number of events 40
|
91.7%
22/24 • Number of events 22
|
|
Blood and lymphatic system disorders
Platelets
|
92.0%
46/50 • Number of events 46
|
88.6%
39/44 • Number of events 39
|
95.8%
23/24 • Number of events 23
|
|
Gastrointestinal disorders
Pneumonitis
|
0.00%
0/50
|
4.5%
2/44 • Number of events 2
|
0.00%
0/24
|
|
Blood and lymphatic system disorders
Prothrombin time (PT)
|
0.00%
0/50
|
6.8%
3/44 • Number of events 3
|
8.3%
2/24 • Number of events 2
|
|
Blood and lymphatic system disorders
Partial thromboplastin time (PTT)
|
0.00%
0/50
|
0.00%
0/44
|
16.7%
4/24 • Number of events 4
|
|
Blood and lymphatic system disorders
SGOT (AST)
|
12.0%
6/50 • Number of events 6
|
0.00%
0/44
|
8.3%
2/24 • Number of events 2
|
|
Blood and lymphatic system disorders
SGPT (ALT)
|
10.0%
5/50 • Number of events 5
|
9.1%
4/44 • Number of events 4
|
0.00%
0/24
|
Additional Information
Dr. Joachim Yahalom
Memorial Sloan Kettering Cancer Center
Phone: 1212-639-5999
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place