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Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00025259
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : March 7, 2017
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma
Childhood Mixed Cellularity Classical Hodgkin Lymphoma
Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma
Childhood Nodular Sclerosis Classical Hodgkin Lymphoma
Stage I Childhood Hodgkin Lymphoma
Stage II Childhood Hodgkin Lymphoma
Stage III Childhood Hodgkin Lymphoma
Stage IV Childhood Hodgkin Lymphoma
Interventions Biological: Bleomycin Sulfate
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Biological: Filgrastim
Radiation: Involved-Field Radiation Therapy
Drug: Prednisone
Drug: Vincristine Sulfate Liposome
Enrollment 1734
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Patients Off-therapy Before Callback-Induction Only) Arm II (RER With CR [ABVE-PC, IFRT]) Arm III (RER With CR [ABVE-PC]) Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) Arm V (RER With PD) Arm VI (SER [DECA, ABVE-PC, IFRT]) Arm VII (SER [ABVE-PC, IFRT])
Hide Arm/Group Description

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Involved-Field Radiation Therapy: Undergo IFRT

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Involved-Field Radiation Therapy: Undergo IFRT

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, & cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 & 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 & G-CSF SC beginning on day 3 & continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.

Bleomycin Sulfate: Given IV or SC

Cisplatin: Given IV

Cyclophosphamide: Given IV

Cytarabine: Given IV

Dexamethasone: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Involved-Field Radiation Therapy: Undergo IFRT

Pre

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Involved-Field Radiation Therapy: Undergo IFRT

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Period Title: Overall Study
Started 52 381 382 571 42 153 153
Completed 7 292 301 457 6 101 102
Not Completed 45 89 81 114 36 52 51
Reason Not Completed
Death             1             3             0             3             0             1             2
Lack of Efficacy             2             46             60             78             11             30             38
Lost to Follow-up             2             9             13             13             1             3             1
Physician Decision             12             1             0             5             4             2             1
Protocol Violation             3             2             2             1             2             1             3
Withdrawal by Subject             9             27             6             14             11             8             3
Ineligible             14             1             0             0             6             0             1
Randomization error             1             0             0             0             1             7             2
Adverse Event             1             0             0             0             0             0             0
Arm/Group Title Arm I (Patients Off-therapy Before Callback-Induction Only) Arm II (RER With CR [ABVE-PC, IFRT]) Arm III (RER With CR [ABVE-PC]) Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) Arm V (RER With PD) Arm VI (SER [DECA, ABVE-PC, IFRT]) Arm VII (SER [ABVE-PC, IFRT]) Total
Hide Arm/Group Description

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Involved-Field Radiation Therapy: Undergo IFRT

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Involved-Field Radiation Therapy: Undergo IFRT

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, & cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 & 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 & G-CSF SC beginning on day 3 & continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.

Bleomycin Sulfate: Given IV or SC

Cisplatin: Given IV

Cyclophosphamide: Given IV

Cytarabine: Given IV

Dexamethasone: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Involved-Field Radiation Therapy: Undergo IFRT

Pre

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Involved-Field Radiation Therapy: Undergo IFRT

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Total of all reporting groups
Overall Number of Baseline Participants 52 381 382 571 42 153 153 1734
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 381 participants 382 participants 571 participants 42 participants 153 participants 153 participants 1734 participants
<=18 years
46
  88.5%
363
  95.3%
369
  96.6%
540
  94.6%
40
  95.2%
143
  93.5%
148
  96.7%
1649
  95.1%
Between 18 and 65 years
6
  11.5%
18
   4.7%
13
   3.4%
31
   5.4%
2
   4.8%
10
   6.5%
5
   3.3%
85
   4.9%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 52 participants 381 participants 382 participants 571 participants 42 participants 153 participants 153 participants 1734 participants
16
(5 to 20)
14
(2 to 21)
14
(3 to 21)
15
(1 to 21)
15
(5 to 19)
15
(5 to 21)
15
(5 to 21)
15
(1 to 21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 381 participants 382 participants 571 participants 42 participants 153 participants 153 participants 1734 participants
Female
21
  40.4%
177
  46.5%
155
  40.6%
288
  50.4%
16
  38.1%
81
  52.9%
77
  50.3%
815
  47.0%
Male
31
  59.6%
204
  53.5%
227
  59.4%
283
  49.6%
26
  61.9%
72
  47.1%
76
  49.7%
919
  53.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 381 participants 382 participants 571 participants 42 participants 153 participants 153 participants 1734 participants
Hispanic or Latino
7
  13.5%
71
  18.6%
67
  17.5%
74
  13.0%
4
   9.5%
22
  14.4%
14
   9.2%
259
  14.9%
Not Hispanic or Latino
44
  84.6%
293
  76.9%
306
  80.1%
487
  85.3%
34
  81.0%
127
  83.0%
134
  87.6%
1425
  82.2%
Unknown or Not Reported
1
   1.9%
17
   4.5%
9
   2.4%
10
   1.8%
4
   9.5%
4
   2.6%
5
   3.3%
50
   2.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 381 participants 382 participants 571 participants 42 participants 153 participants 153 participants 1734 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   0.3%
2
   0.4%
0
   0.0%
0
   0.0%
1
   0.7%
4
   0.2%
Asian
1
   1.9%
15
   3.9%
12
   3.1%
11
   1.9%
1
   2.4%
4
   2.6%
6
   3.9%
50
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
2
   0.5%
2
   0.4%
1
   2.4%
1
   0.7%
0
   0.0%
6
   0.3%
Black or African American
5
   9.6%
45
  11.8%
43
  11.3%
67
  11.7%
6
  14.3%
14
   9.2%
14
   9.2%
194
  11.2%
White
41
  78.8%
290
  76.1%
297
  77.7%
444
  77.8%
30
  71.4%
122
  79.7%
124
  81.0%
1348
  77.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
   9.6%
31
   8.1%
27
   7.1%
45
   7.9%
4
   9.5%
12
   7.8%
8
   5.2%
132
   7.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants 381 participants 382 participants 571 participants 42 participants 153 participants 153 participants 1734 participants
New Zealand 1 0 0 3 0 0 0 4
Canada 8 30 45 51 1 20 20 175
United States 41 333 312 491 39 125 128 1469
Israel 0 3 1 1 0 1 0 6
Australia 0 8 13 12 0 3 4 40
Switzerland 0 0 0 1 0 0 0 1
Kuwait 1 0 0 0 0 0 0 1
France 0 1 0 0 0 0 0 1
Netherlands 0 2 9 7 1 3 0 22
Puerto Rico 1 4 2 4 0 1 1 13
Bermuda 0 0 0 1 0 0 0 1
French Polynesia 0 0 0 0 1 0 0 1
1.Primary Outcome
Title Event-free Survival
Hide Description Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Arm/Group Title Arm I (Patients Off-therapy Before Callback-Induction Only) Arm II (RER With CR [ABVE-PC, IFRT]) Arm III (RER With CR [ABVE-PC]) Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) Arm V (RER With PD) Arm VI (SER [DECA, ABVE-PC, IFRT]) Arm VII (SER [ABVE-PC, IFRT])
Hide Arm/Group Description:
All patients-off therapy before callback-Induction only
RER with Complete Response - IFRT (Standard Arm)
RER with Complete Response - no IFRT (Reduced Therapy Arm)
RER with less than Complete Response - IFRT
RER with Progressive Disease - Off Therapy
SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
SER - randomized to ABVE-PCX2 + IFRT
Overall Number of Participants Analyzed 38 380 382 571 36 153 152
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of survival
0.89
(0.69 to 0.96)
0.87
(0.83 to 0.90)
0.84
(0.80 to 0.87)
0.87
(0.83 to 0.89)
0.70
(0.51 to 0.82)
0.79
(0.71 to 0.85)
0.74
(0.66 to 0.80)
2.Secondary Outcome
Title Disease Response Assessed by Modified RECIST Criteria
Hide Description Number of participants with complete response and very good partial response at the end of protocol therapy.
Time Frame Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Arm/Group Title Arm I (Patients Off-therapy Before Callback-Induction Only) Arm II (RER With CR [ABVE-PC, IFRT]) Arm III (RER With CR [ABVE-PC]) Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) Arm V (RER With PD) Arm VI (SER [DECA, ABVE-PC, IFRT]) Arm VII (SER [ABVE-PC, IFRT])
Hide Arm/Group Description:
All patients-off therapy before callback-Induction only
RER with Complete Response - IFRT (Standard Arm)
RER with Complete Response - no IFRT ( Reduced Therapy Arm)
RER with less than Complete Response - IFRT
RER with Progressive Disease - Off Therapy
SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
SER - randomized to ABVE-PCX2 + IFRT
Overall Number of Participants Analyzed 38 380 382 571 36 153 152
Measure Type: Number
Unit of Measure: Number of participants
5 370 380 538 29 105 100
3.Secondary Outcome
Title Grade 3 or 4 Non-hematologic Toxicity
Hide Description Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated.
Time Frame Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Arm/Group Title Arm I (Patients Off-therapy Before Callback-Induction Only) Arm II (RER With CR [ABVE-PC, IFRT]) Arm III (RER With CR [ABVE-PC]) Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) Arm V (RER With PD) Arm VI (SER [DECA, ABVE-PC, IFRT]) Arm VII (SER [ABVE-PC, IFRT])
Hide Arm/Group Description:
All patients-off therapy before callback-Induction only
RER with Complete Response - IFRT (Standard Arm)
RER with Complete Response - no IFRT ( Reduced Therapy Arm)
RER with less than Complete Response - IFRT
RER with Progressive Disease - Off Therapy
SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
SER - randomized to ABVE-PCX2 + IFRT
Overall Number of Participants Analyzed 38 380 382 571 36 153 152
Measure Type: Number
Unit of Measure: Number of participants
10 153 130 216 11 62 45
4.Secondary Outcome
Title Overall Survival
Hide Description Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Arm V (RER with PD), has been excluded as there were no deaths observed by the Time Frame of 5 years. Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
Arm/Group Title Arm I (Patients Off-therapy Before Callback-Induction Only) Arm II (RER With CR [ABVE-PC, IFRT]) Arm III (RER With CR [ABVE-PC]) Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) Arm VI (SER [DECA, ABVE-PC, IFRT]) Arm VII (SER [ABVE-PC, IFRT])
Hide Arm/Group Description:
All patients-off therapy before callback-Induction only
RER with Complete Response - IFRT (Standard Arm)
RER with Complete Response - no IFRT ( Reduced Therapy Arm)
RER with less than Complete Response - IFRT
SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
SER - randomized to ABVE-PCX2 + IFRT
Overall Number of Participants Analyzed 38 380 382 571 153 152
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of survival
0.93
(0.74 to 0.98)
0.98
(0.96 to 0.99)
0.98
(0.96 to 0.99)
0.98
(0.96 to 0.99)
0.96
(0.91 to 0.98)
0.93
(0.87 to 0.96)
Time Frame [Not Specified]
Adverse Event Reporting Description

Serious AE:

Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).

Other AE:

Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).

 
Arm/Group Title Arm I (Patients Off-therapy Before Callback-Induction Only) Arm II (RER With CR [ABVE-PC, IFRT]) Arm III (RER With CR [ABVE-PC]) Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) Arm V (RER With PD) Arm VI (SER [DECA, ABVE-PC, IFRT]) Arm VII (SER [ABVE-PC, IFRT])
Hide Arm/Group Description

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Involved-Field Radiation Therapy: Undergo IFRT

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Involved-Field Radiation Therapy: Undergo IFRT

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, & cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 & 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 & G-CSF SC beginning on day 3 & continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.

Bleomycin Sulfate: Given IV or SC

Cisplatin: Given IV

Cyclophosphamide: Given IV

Cytarabine: Given IV

Dexamethasone: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Involved-Field Radiation Therapy: Undergo IFRT

Pre

Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.

Bleomycin Sulfate: Given IV or SC

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Etoposide: Given IV

Filgrastim: Given SC

Involved-Field Radiation Therapy: Undergo IFRT

Prednisone: Given orally

Vincristine Sulfate Liposome: Given IV

All-Cause Mortality
Arm I (Patients Off-therapy Before Callback-Induction Only) Arm II (RER With CR [ABVE-PC, IFRT]) Arm III (RER With CR [ABVE-PC]) Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) Arm V (RER With PD) Arm VI (SER [DECA, ABVE-PC, IFRT]) Arm VII (SER [ABVE-PC, IFRT])
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Arm I (Patients Off-therapy Before Callback-Induction Only) Arm II (RER With CR [ABVE-PC, IFRT]) Arm III (RER With CR [ABVE-PC]) Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) Arm V (RER With PD) Arm VI (SER [DECA, ABVE-PC, IFRT]) Arm VII (SER [ABVE-PC, IFRT])
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/38 (2.63%)      2/380 (0.53%)      1/382 (0.26%)      5/571 (0.88%)      1/36 (2.78%)      2/153 (1.31%)      1/152 (0.66%)    
Blood and lymphatic system disorders               
Anemia  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Blood and lymphatic system disorders - Other, specify  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Febrile neutropenia  0/38 (0.00%)  0 1/380 (0.26%)  1 1/382 (0.26%)  1 0/571 (0.00%)  0 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Gastrointestinal disorders               
Diarrhea  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Nausea  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 1/152 (0.66%)  1
Vomiting  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Immune system disorders               
Anaphylaxis  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 2/571 (0.35%)  2 1/36 (2.78%)  1 0/153 (0.00%)  0 1/152 (0.66%)  1
Investigations               
Blood antidiuretic hormone abnormal  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Lymphocyte count decreased  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Neutrophil count decreased  0/38 (0.00%)  0 2/380 (0.53%)  2 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Platelet count decreased  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
White blood cell decreased  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 2/571 (0.35%)  2 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Nervous system disorders               
Peripheral motor neuropathy  1/38 (2.63%)  1 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Dyspnea  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 1/152 (0.66%)  1
Hypoxia  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 1/152 (0.66%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Patients Off-therapy Before Callback-Induction Only) Arm II (RER With CR [ABVE-PC, IFRT]) Arm III (RER With CR [ABVE-PC]) Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) Arm V (RER With PD) Arm VI (SER [DECA, ABVE-PC, IFRT]) Arm VII (SER [ABVE-PC, IFRT])
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/38 (60.53%)      341/380 (89.74%)      334/382 (87.43%)      497/571 (87.04%)      26/36 (72.22%)      135/153 (88.24%)      133/152 (87.50%)    
Blood and lymphatic system disorders               
Anemia  4/38 (10.53%)  4 196/380 (51.58%)  196 162/382 (42.41%)  162 245/571 (42.91%)  245 12/36 (33.33%)  12 85/153 (55.56%)  85 63/152 (41.45%)  63
Blood and lymphatic system disorders - Other, specify  1/38 (2.63%)  1 50/380 (13.16%)  50 35/382 (9.16%)  35 57/571 (9.98%)  57 0/36 (0.00%)  0 31/153 (20.26%)  31 20/152 (13.16%)  20
Disseminated intravascular coagulation  1/38 (2.63%)  1 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Febrile neutropenia  5/38 (13.16%)  5 111/380 (29.21%)  111 99/382 (25.92%)  99 128/571 (22.42%)  128 3/36 (8.33%)  3 45/153 (29.41%)  45 31/152 (20.39%)  31
Cardiac disorders               
Cardiac disorders - Other, specify  2/38 (5.26%)  2 1/380 (0.26%)  1 2/382 (0.52%)  2 1/571 (0.18%)  1 0/36 (0.00%)  0 3/153 (1.96%)  3 0/152 (0.00%)  0
Left ventricular systolic dysfunction  1/38 (2.63%)  1 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Sinus tachycardia  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 2/571 (0.35%)  2 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Supraventricular tachycardia  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Ear and labyrinth disorders               
Hearing impaired  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Endocrine disorders               
Endocrine disorders - Other, specify  0/38 (0.00%)  0 0/380 (0.00%)  0 1/382 (0.26%)  1 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Eye disorders               
Blurred vision  0/38 (0.00%)  0 0/380 (0.00%)  0 1/382 (0.26%)  1 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Eye disorders - Other, specify  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Gastrointestinal disorders               
Abdominal pain  2/38 (5.26%)  2 4/380 (1.05%)  4 6/382 (1.57%)  6 12/571 (2.10%)  12 0/36 (0.00%)  0 1/153 (0.65%)  1 1/152 (0.66%)  1
Anal fistula  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 1/152 (0.66%)  1
Ascites  1/38 (2.63%)  1 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Colitis  1/38 (2.63%)  1 3/380 (0.79%)  3 0/382 (0.00%)  0 5/571 (0.88%)  5 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Constipation  0/38 (0.00%)  0 4/380 (1.05%)  4 4/382 (1.05%)  4 2/571 (0.35%)  2 1/36 (2.78%)  1 1/153 (0.65%)  1 0/152 (0.00%)  0
Diarrhea  1/38 (2.63%)  1 2/380 (0.53%)  2 2/382 (0.52%)  2 9/571 (1.58%)  9 0/36 (0.00%)  0 3/153 (1.96%)  3 0/152 (0.00%)  0
Dyspepsia  0/38 (0.00%)  0 2/380 (0.53%)  2 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Dysphagia  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Esophagitis  0/38 (0.00%)  0 2/380 (0.53%)  2 2/382 (0.52%)  2 2/571 (0.35%)  2 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Gastric hemorrhage  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Gastrointestinal disorders - Other, specify  1/38 (2.63%)  1 1/380 (0.26%)  1 0/382 (0.00%)  0 2/571 (0.35%)  2 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Ileus  0/38 (0.00%)  0 3/380 (0.79%)  3 2/382 (0.52%)  2 3/571 (0.53%)  3 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Lower gastrointestinal hemorrhage  1/38 (2.63%)  1 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Mucositis oral  0/38 (0.00%)  0 20/380 (5.26%)  20 9/382 (2.36%)  9 25/571 (4.38%)  25 1/36 (2.78%)  1 10/153 (6.54%)  10 2/152 (1.32%)  2
Nausea  1/38 (2.63%)  1 6/380 (1.58%)  6 5/382 (1.31%)  5 21/571 (3.68%)  21 0/36 (0.00%)  0 6/153 (3.92%)  6 2/152 (1.32%)  2
Pancreatitis  0/38 (0.00%)  0 2/380 (0.53%)  2 1/382 (0.26%)  1 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Rectal hemorrhage  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 1/153 (0.65%)  1 1/152 (0.66%)  1
Rectal pain  0/38 (0.00%)  0 2/380 (0.53%)  2 0/382 (0.00%)  0 2/571 (0.35%)  2 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Typhlitis  3/38 (7.89%)  3 4/380 (1.05%)  4 3/382 (0.79%)  3 7/571 (1.23%)  7 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Vomiting  1/38 (2.63%)  1 6/380 (1.58%)  6 9/382 (2.36%)  9 19/571 (3.33%)  19 0/36 (0.00%)  0 9/153 (5.88%)  9 3/152 (1.97%)  3
General disorders               
Chills  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Fatigue  1/38 (2.63%)  1 1/380 (0.26%)  1 1/382 (0.26%)  1 3/571 (0.53%)  3 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Fever  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 5/571 (0.88%)  5 0/36 (0.00%)  0 0/153 (0.00%)  0 1/152 (0.66%)  1
General disorders and administration site conditions - Other, specify  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Non-cardiac chest pain  0/38 (0.00%)  0 1/380 (0.26%)  1 1/382 (0.26%)  1 1/571 (0.18%)  1 0/36 (0.00%)  0 2/153 (1.31%)  2 0/152 (0.00%)  0
Pain  0/38 (0.00%)  0 4/380 (1.05%)  4 4/382 (1.05%)  4 13/571 (2.28%)  13 0/36 (0.00%)  0 2/153 (1.31%)  2 0/152 (0.00%)  0
Immune system disorders               
Anaphylaxis  1/38 (2.63%)  1 14/380 (3.68%)  14 8/382 (2.09%)  8 20/571 (3.50%)  20 1/36 (2.78%)  1 4/153 (2.61%)  4 6/152 (3.95%)  6
Immune system disorders - Other, specify  0/38 (0.00%)  0 1/380 (0.26%)  1 2/382 (0.52%)  2 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 1/152 (0.66%)  1
Infections and infestations               
Catheter related infection  3/38 (7.89%)  3 14/380 (3.68%)  14 13/382 (3.40%)  13 17/571 (2.98%)  17 1/36 (2.78%)  1 3/153 (1.96%)  3 4/152 (2.63%)  4
Infections and infestations - Other, specify  4/38 (10.53%)  4 71/380 (18.68%)  71 61/382 (15.97%)  61 79/571 (13.84%)  79 6/36 (16.67%)  6 26/153 (16.99%)  26 16/152 (10.53%)  16
Wound infection  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 2/153 (1.31%)  2 0/152 (0.00%)  0
Investigations               
Activated partial thromboplastin time prolonged  1/38 (2.63%)  1 2/380 (0.53%)  2 0/382 (0.00%)  0 2/571 (0.35%)  2 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Alanine aminotransferase increased  0/38 (0.00%)  0 1/380 (0.26%)  1 1/382 (0.26%)  1 5/571 (0.88%)  5 0/36 (0.00%)  0 1/153 (0.65%)  1 2/152 (1.32%)  2
Aspartate aminotransferase increased  0/38 (0.00%)  0 0/380 (0.00%)  0 1/382 (0.26%)  1 2/571 (0.35%)  2 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Blood antidiuretic hormone abnormal  0/38 (0.00%)  0 0/380 (0.00%)  0 1/382 (0.26%)  1 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Blood bilirubin increased  1/38 (2.63%)  1 0/380 (0.00%)  0 0/382 (0.00%)  0 3/571 (0.53%)  3 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Carbon monoxide diffusing capacity decreased  2/38 (5.26%)  2 11/380 (2.89%)  11 3/382 (0.79%)  3 11/571 (1.93%)  11 0/36 (0.00%)  0 3/153 (1.96%)  3 0/152 (0.00%)  0
Cardiac troponin I increased  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Fibrinogen decreased  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Forced expiratory volume decreased  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
INR increased  0/38 (0.00%)  0 3/380 (0.79%)  3 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Investigations - Other, specify  0/38 (0.00%)  0 1/380 (0.26%)  1 1/382 (0.26%)  1 0/571 (0.00%)  0 0/36 (0.00%)  0 2/153 (1.31%)  2 0/152 (0.00%)  0
Lipase increased  0/38 (0.00%)  0 0/380 (0.00%)  0 1/382 (0.26%)  1 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Lymphocyte count decreased  2/38 (5.26%)  2 14/380 (3.68%)  14 19/382 (4.97%)  19 53/571 (9.28%)  53 1/36 (2.78%)  1 24/153 (15.69%)  24 17/152 (11.18%)  17
Neutrophil count decreased  17/38 (44.74%)  17 319/380 (83.95%)  319 307/382 (80.37%)  307 449/571 (78.63%)  449 20/36 (55.56%)  20 126/153 (82.35%)  126 116/152 (76.32%)  116
Platelet count decreased  3/38 (7.89%)  3 152/380 (40.00%)  152 119/382 (31.15%)  119 167/571 (29.25%)  167 5/36 (13.89%)  5 98/153 (64.05%)  98 55/152 (36.18%)  55
Serum amylase increased  1/38 (2.63%)  1 1/380 (0.26%)  1 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Weight loss  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
White blood cell decreased  5/38 (13.16%)  5 71/380 (18.68%)  71 69/382 (18.06%)  69 126/571 (22.07%)  126 1/36 (2.78%)  1 50/153 (32.68%)  50 31/152 (20.39%)  31
Metabolism and nutrition disorders               
Acidosis  1/38 (2.63%)  1 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 1/153 (0.65%)  1 1/152 (0.66%)  1
Anorexia  1/38 (2.63%)  1 4/380 (1.05%)  4 1/382 (0.26%)  1 0/571 (0.00%)  0 0/36 (0.00%)  0 3/153 (1.96%)  3 0/152 (0.00%)  0
Dehydration  0/38 (0.00%)  0 3/380 (0.79%)  3 10/382 (2.62%)  10 9/571 (1.58%)  9 0/36 (0.00%)  0 2/153 (1.31%)  2 2/152 (1.32%)  2
Hypercalcemia  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Hyperglycemia  1/38 (2.63%)  1 7/380 (1.84%)  7 5/382 (1.31%)  5 4/571 (0.70%)  4 1/36 (2.78%)  1 8/153 (5.23%)  8 1/152 (0.66%)  1
Hyperkalemia  0/38 (0.00%)  0 2/380 (0.53%)  2 0/382 (0.00%)  0 3/571 (0.53%)  3 0/36 (0.00%)  0 3/153 (1.96%)  3 1/152 (0.66%)  1
Hyperuricemia  0/38 (0.00%)  0 0/380 (0.00%)  0 1/382 (0.26%)  1 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 1/152 (0.66%)  1
Hypoalbuminemia  1/38 (2.63%)  1 2/380 (0.53%)  2 2/382 (0.52%)  2 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Hypocalcemia  1/38 (2.63%)  1 4/380 (1.05%)  4 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Hypoglycemia  0/38 (0.00%)  0 1/380 (0.26%)  1 1/382 (0.26%)  1 3/571 (0.53%)  3 0/36 (0.00%)  0 0/153 (0.00%)  0 1/152 (0.66%)  1
Hypokalemia  2/38 (5.26%)  2 12/380 (3.16%)  12 7/382 (1.83%)  7 17/571 (2.98%)  17 0/36 (0.00%)  0 5/153 (3.27%)  5 1/152 (0.66%)  1
Hypomagnesemia  0/38 (0.00%)  0 0/380 (0.00%)  0 1/382 (0.26%)  1 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Hyponatremia  1/38 (2.63%)  1 7/380 (1.84%)  7 4/382 (1.05%)  4 9/571 (1.58%)  9 0/36 (0.00%)  0 2/153 (1.31%)  2 1/152 (0.66%)  1
Hypophosphatemia  0/38 (0.00%)  0 2/380 (0.53%)  2 2/382 (0.52%)  2 5/571 (0.88%)  5 0/36 (0.00%)  0 3/153 (1.96%)  3 0/152 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Arthralgia  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 2/571 (0.35%)  2 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Arthritis  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Bone pain  0/38 (0.00%)  0 0/380 (0.00%)  0 3/382 (0.79%)  3 7/571 (1.23%)  7 0/36 (0.00%)  0 0/153 (0.00%)  0 4/152 (2.63%)  4
Generalized muscle weakness  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, specify  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 2/571 (0.35%)  2 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Myalgia  0/38 (0.00%)  0 0/380 (0.00%)  0 2/382 (0.52%)  2 4/571 (0.70%)  4 0/36 (0.00%)  0 1/153 (0.65%)  1 1/152 (0.66%)  1
Myositis  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Nervous system disorders               
Dizziness  0/38 (0.00%)  0 1/380 (0.26%)  1 2/382 (0.52%)  2 2/571 (0.35%)  2 0/36 (0.00%)  0 0/153 (0.00%)  0 1/152 (0.66%)  1
Headache  0/38 (0.00%)  0 4/380 (1.05%)  4 3/382 (0.79%)  3 6/571 (1.05%)  6 0/36 (0.00%)  0 0/153 (0.00%)  0 1/152 (0.66%)  1
Nervous system disorders - Other, specify  0/38 (0.00%)  0 0/380 (0.00%)  0 1/382 (0.26%)  1 2/571 (0.35%)  2 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Neuralgia  0/38 (0.00%)  0 7/380 (1.84%)  7 3/382 (0.79%)  3 6/571 (1.05%)  6 0/36 (0.00%)  0 1/153 (0.65%)  1 1/152 (0.66%)  1
Peripheral motor neuropathy  0/38 (0.00%)  0 1/380 (0.26%)  1 3/382 (0.79%)  3 8/571 (1.40%)  8 1/36 (2.78%)  1 0/153 (0.00%)  0 0/152 (0.00%)  0
Peripheral sensory neuropathy  0/38 (0.00%)  0 1/380 (0.26%)  1 5/382 (1.31%)  5 4/571 (0.70%)  4 1/36 (2.78%)  1 1/153 (0.65%)  1 0/152 (0.00%)  0
Pyramidal tract syndrome  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Seizure  0/38 (0.00%)  0 0/380 (0.00%)  0 2/382 (0.52%)  2 0/571 (0.00%)  0 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Syncope  0/38 (0.00%)  0 5/380 (1.32%)  5 5/382 (1.31%)  5 7/571 (1.23%)  7 0/36 (0.00%)  0 2/153 (1.31%)  2 1/152 (0.66%)  1
Vasovagal reaction  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Psychiatric disorders               
Anxiety  0/38 (0.00%)  0 0/380 (0.00%)  0 1/382 (0.26%)  1 3/571 (0.53%)  3 0/36 (0.00%)  0 1/153 (0.65%)  1 2/152 (1.32%)  2
Depression  0/38 (0.00%)  0 1/380 (0.26%)  1 2/382 (0.52%)  2 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Insomnia  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 2/571 (0.35%)  2 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Personality change  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 3/571 (0.53%)  3 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Psychosis  0/38 (0.00%)  0 1/380 (0.26%)  1 1/382 (0.26%)  1 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 1/152 (0.66%)  1
Reproductive system and breast disorders               
Irregular menstruation  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 1/152 (0.66%)  1
Vaginal hemorrhage  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Cough  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Dyspnea  1/38 (2.63%)  1 2/380 (0.53%)  2 3/382 (0.79%)  3 5/571 (0.88%)  5 0/36 (0.00%)  0 1/153 (0.65%)  1 1/152 (0.66%)  1
Epistaxis  0/38 (0.00%)  0 2/380 (0.53%)  2 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 0/152 (0.00%)  0
Hypoxia  0/38 (0.00%)  0 3/380 (0.79%)  3 2/382 (0.52%)  2 4/571 (0.70%)  4 0/36 (0.00%)  0 1/153 (0.65%)  1 1/152 (0.66%)  1
Pleural effusion  2/38 (5.26%)  2 2/380 (0.53%)  2 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Pleuritic pain  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 0/153 (0.00%)  0 1/152 (0.66%)  1
Respiratory, thoracic and mediastinal disorders - Other, specify  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 1/152 (0.66%)  1
Skin and subcutaneous tissue disorders               
Pruritus  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Rash maculo-papular  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 1/571 (0.18%)  1 0/36 (0.00%)  0 1/153 (0.65%)  1 0/152 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  0/38 (0.00%)  0 1/380 (0.26%)  1 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 0/153 (0.00%)  0 1/152 (0.66%)  1
Vascular disorders               
Hypertension  0/38 (0.00%)  0 1/380 (0.26%)  1 2/382 (0.52%)  2 3/571 (0.53%)  3 0/36 (0.00%)  0 1/153 (0.65%)  1 1/152 (0.66%)  1
Hypotension  2/38 (5.26%)  2 11/380 (2.89%)  11 8/382 (2.09%)  8 13/571 (2.28%)  13 0/36 (0.00%)  0 2/153 (1.31%)  2 2/152 (1.32%)  2
Thromboembolic event  0/38 (0.00%)  0 7/380 (1.84%)  7 2/382 (0.52%)  2 14/571 (2.45%)  14 0/36 (0.00%)  0 3/153 (1.96%)  3 3/152 (1.97%)  3
Vascular disorders - Other, specify  0/38 (0.00%)  0 0/380 (0.00%)  0 0/382 (0.00%)  0 0/571 (0.00%)  0 0/36 (0.00%)  0 2/153 (1.31%)  2 0/152 (0.00%)  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Must obtain prior approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00025259    
Other Study ID Numbers: AHOD0031
NCI-2011-02069 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000068943
COG-AHOD0031
AHOD0031 ( Other Identifier: Childrens Oncology Group )
AHOD0031 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: October 11, 2001
First Posted: January 27, 2003
Results First Submitted: October 19, 2016
Results First Posted: March 7, 2017
Last Update Posted: April 12, 2017