Trial Outcomes & Findings for Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed or Refractory Hodgkin's Lymphoma (NCT NCT00255723)
NCT ID: NCT00255723
Last Updated: 2016-02-01
Results Overview
Overall objective response to therapy Complete remission/unconfirmed (CRu) This includes patients who meet criteria for CR with the following exceptions: 1\. A residual lymph node mass \> 1.5 cm in the short axis with normalization of 18Ffluorodeoxyglucose- PET scan Partial remission/minimal response (PR and MR) 1. Any decrease in lymph nodes and nodal-based masses 2. Any decrease in PET avidity (however, residual FDG uptake is present) 3. Involving organs involved prior to therapy must have diminished in size. 4. No new sites of disease Stable disease Response is less than that which constitutes a PR and disease does not meet criteria for progressive disease Progressive disease 1\. Increase in lymph nodes or nodal-based masses, or other measurable disease from pretreatment observations. 2. Appearance of any new lesion at the end of therapy
COMPLETED
PHASE2
98 participants
3 years
2016-02-01
Participant Flow
Participant milestones
| Measure |
Arm A
Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
|
Arm B
Augmented ICE x 2 cycles (2 risk factors)
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
41
|
|
Overall Study
COMPLETED
|
54
|
39
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Arm A
Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
|
Arm B
Augmented ICE x 2 cycles (2 risk factors)
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Response Data Not Available
|
1
|
0
|
Baseline Characteristics
Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed or Refractory Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Arm A
n=56 Participants
Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
|
Arm B
n=41 Participants
Augmented ICE x 2 cycles (2 risk factors)
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsOverall objective response to therapy Complete remission/unconfirmed (CRu) This includes patients who meet criteria for CR with the following exceptions: 1\. A residual lymph node mass \> 1.5 cm in the short axis with normalization of 18Ffluorodeoxyglucose- PET scan Partial remission/minimal response (PR and MR) 1. Any decrease in lymph nodes and nodal-based masses 2. Any decrease in PET avidity (however, residual FDG uptake is present) 3. Involving organs involved prior to therapy must have diminished in size. 4. No new sites of disease Stable disease Response is less than that which constitutes a PR and disease does not meet criteria for progressive disease Progressive disease 1\. Increase in lymph nodes or nodal-based masses, or other measurable disease from pretreatment observations. 2. Appearance of any new lesion at the end of therapy
Outcome measures
| Measure |
Arm A
n=54 Participants
Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
|
Arm B
n=39 Participants
Augmented ICE x 2 cycles (2 risk factors)
|
|---|---|---|
|
Overall Objective Response
Complete Remission
|
45 participants
|
31 participants
|
|
Overall Objective Response
Partial Remission (PR)
|
6 participants
|
1 participants
|
|
Overall Objective Response
Progression of Disease (POD)
|
3 participants
|
7 participants
|
Adverse Events
Arm A
Arm B
Serious adverse events
| Measure |
Arm A
n=56 participants at risk
Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
|
Arm B
n=41 participants at risk
Augmented ICE x 2 cycles (2 risk factors)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
0.00%
0/56
|
2.4%
1/41 • Number of events 1
|
|
Renal and urinary disorders
Cystitis
|
1.8%
1/56 • Number of events 1
|
0.00%
0/41
|
|
General disorders
Cytokine release syndrome/acute infusion reaction
|
1.8%
1/56 • Number of events 1
|
0.00%
0/41
|
|
General disorders
Death not associated with CTCAE term- Death NOS
|
0.00%
0/56
|
2.4%
1/41 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin, other
|
0.00%
0/56
|
4.9%
2/41 • Number of events 2
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/56
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/56
|
4.9%
2/41 • Number of events 2
|
|
General disorders
Febrile neutropenia
|
1.8%
1/56 • Number of events 2
|
9.8%
4/41 • Number of events 4
|
|
Infections and infestations
Catheter related infection
|
3.6%
2/56 • Number of events 2
|
9.8%
4/41 • Number of events 4
|
|
Infections and infestations
Infective myositis
|
0.00%
0/56
|
2.4%
1/41 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/56
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
Sepsis
|
1.8%
1/56 • Number of events 2
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.8%
1/56 • Number of events 1
|
0.00%
0/41
|
|
Infections and infestations
Wound infection
|
1.8%
1/56 • Number of events 2
|
0.00%
0/41
|
|
Infections and infestations
Infection, other
|
1.8%
1/56 • Number of events 1
|
0.00%
0/41
|
|
Gastrointestinal disorders
Large intestinal mucositis
|
0.00%
0/56
|
2.4%
1/41 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
1.8%
1/56 • Number of events 1
|
0.00%
0/41
|
|
General disorders
Pain - Chest/thorax NOS
|
1.8%
1/56 • Number of events 1
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Pericardial effusion (non-malignant)
|
1.8%
1/56 • Number of events 1
|
0.00%
0/41
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
1.8%
1/56 • Number of events 1
|
0.00%
0/41
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/56
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Thrombosis/thrombus/embolism
|
0.00%
0/56
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Vascular- Other
|
0.00%
0/56
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/56
|
2.4%
1/41 • Number of events 1
|
Other adverse events
| Measure |
Arm A
n=56 participants at risk
Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
|
Arm B
n=41 participants at risk
Augmented ICE x 2 cycles (2 risk factors)
|
|---|---|---|
|
Blood and lymphatic system disorders
ALT, SGPT
|
12.5%
7/56 • Number of events 7
|
9.8%
4/41 • Number of events 4
|
|
Blood and lymphatic system disorders
AST, SGOT
|
8.9%
5/56 • Number of events 5
|
0.00%
0/41
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
7.1%
4/56 • Number of events 4
|
12.2%
5/41 • Number of events 5
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
17.9%
10/56 • Number of events 10
|
24.4%
10/41 • Number of events 10
|
|
Blood and lymphatic system disorders
Hemoglobin
|
87.5%
49/56 • Number of events 49
|
95.1%
39/41 • Number of events 39
|
|
Blood and lymphatic system disorders
Prothrombin Time and International Normalized Ratio
|
7.1%
4/56 • Number of events 4
|
0.00%
0/41
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
98.2%
55/56 • Number of events 55
|
95.1%
39/41 • Number of events 39
|
|
Blood and lymphatic system disorders
Lymphopenia
|
98.2%
55/56 • Number of events 55
|
100.0%
41/41 • Number of events 41
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes
|
98.2%
55/56 • Number of events 55
|
95.1%
39/41 • Number of events 39
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
67.9%
38/56 • Number of events 38
|
56.1%
23/41 • Number of events 23
|
|
Blood and lymphatic system disorders
Platelets
|
98.2%
55/56 • Number of events 55
|
92.7%
38/41 • Number of events 38
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
42.9%
24/56 • Number of events 24
|
41.5%
17/41 • Number of events 17
|
|
Blood and lymphatic system disorders
Partial thromboplastin time (PTT)
|
10.7%
6/56 • Number of events 6
|
0.00%
0/41
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
28.6%
16/56 • Number of events 16
|
34.1%
14/41 • Number of events 14
|
Additional Information
Dr. Craig Moskowitz
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place