Trial Outcomes & Findings for S0410 Tandem Stem Cell Transplantation in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma (NCT NCT00233987)
NCT ID: NCT00233987
Last Updated: 2018-03-01
Results Overview
Measured from date of randomization to date of first observation of progressive disease, or death due to any cause
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
At day 60, then every 6 months for 2 years
Results posted on
2018-03-01
Participant Flow
Participant milestones
| Measure |
High-dose Therapy Plus Tandem Transplant
Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either Total Body Irradiation(TBI)-based or 1,3-bis (2-chloroethyl)-1-nitrosourea(BCNU)-based high-dose therapy followed by infusion of at least 2 million cluster of differentiation 34 positive (CD34+) cells.
|
|---|---|
|
Overall Study
STARTED
|
98
|
|
Overall Study
Eligible
|
94
|
|
Overall Study
Eligible and Treated
|
92
|
|
Overall Study
COMPLETED
|
83
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
High-dose Therapy Plus Tandem Transplant
Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either Total Body Irradiation(TBI)-based or 1,3-bis (2-chloroethyl)-1-nitrosourea(BCNU)-based high-dose therapy followed by infusion of at least 2 million cluster of differentiation 34 positive (CD34+) cells.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Reason Under Review
|
1
|
|
Overall Study
Other - Not Protocol Specified
|
5
|
|
Overall Study
Eligible but No Treatment Received
|
2
|
|
Overall Study
Ineligible
|
4
|
Baseline Characteristics
S0410 Tandem Stem Cell Transplantation in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
High-dose Therapy Plus Tandem Transplant
n=92 Participants
Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
|
|---|---|
|
Age, Continuous
|
34.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At day 60, then every 6 months for 2 yearsPopulation: All eligible patients who started treatment were included in the analysis
Measured from date of randomization to date of first observation of progressive disease, or death due to any cause
Outcome measures
| Measure |
High-dose Therapy Plus Tandem Transplant
n=92 Participants
Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
|
|---|---|
|
2-year Progression-free Survival
|
59 percentage of participants
Interval 49.0 to 69.0
|
SECONDARY outcome
Timeframe: At day 60, then every 6 months for 2 yearsPopulation: All eligible patients who started treatment were included in the analysis. Five patients with no evidence of disease at baseline were excluded.
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Outcome measures
| Measure |
High-dose Therapy Plus Tandem Transplant
n=87 Participants
Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
|
|---|---|
|
Response Rate
Partial Response
|
8 participants
|
|
Response Rate
Assessment Inadequate
|
26 participants
|
|
Response Rate
Complete Response
|
15 participants
|
|
Response Rate
Unconfirmed Complete Response
|
3 participants
|
|
Response Rate
Unconfirmed Partial Response
|
2 participants
|
|
Response Rate
No Response
|
33 participants
|
SECONDARY outcome
Timeframe: At day 60, then every 6 months for 2 years, then annually for a total of 7 yearsPopulation: All eligible patients who started treatment were included in the analysis
Measured from date of registration to date of death due to any cause or last contact
Outcome measures
| Measure |
High-dose Therapy Plus Tandem Transplant
n=92 Participants
Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
|
|---|---|
|
Overall Survival
|
91 percentage of participants
Interval 83.0 to 95.0
|
SECONDARY outcome
Timeframe: Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusionPopulation: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Outcome measures
| Measure |
High-dose Therapy Plus Tandem Transplant
n=90 Participants
Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
|
|---|---|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
ALT, SGPT (serum glutamic pyruvic transaminase)
|
6 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
AST, SGOT
|
4 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Allergic reaction/hypersensitivity
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Anorexia
|
20 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Bilirubin (hyperbilirubinemia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Calcium, serum-low (hypocalcemia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Colitis, infectious (e.g., Clostridium difficile)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Confusion
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Constitutional Symptoms-Other (Specify)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Cough
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dehydration
|
6 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dermatology/Skin-Other (Specify)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Diarrhea
|
8 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Distention/bloating, abdominal
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dry mouth/salivary gland (xerostomia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dysphagia (difficulty swallowing)
|
6 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Dyspnea (shortness of breath)
|
5 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Edema: limb
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Esophagitis
|
5 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Fatigue (asthenia, lethargy, malaise)
|
4 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Febrile neutropenia
|
47 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Glucose, serum-high (hyperglycemia)
|
6 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemoglobin
|
22 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemorrhage, pulmonary/upper respiratory - Nose
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hemorrhage/Bleeding-Other (Specify)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hypotension
|
10 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hypoxia
|
4 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Abdomen NOS
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Foreign body
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Rectum
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Sinus
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Skin
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Stomach
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Infection with unknown ANC - Blood
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Infection with unknown ANC - Skin (cellulitis)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Infection-Other (Specify)
|
5 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Leukocytes (total WBC)
|
65 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Lymphatics-Other (Specify)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
50 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Magnesium, serum-high (hypermagnesemia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Mood alteration - depression
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Mucositis/stomatitis (clinical exam) - Oral cavity
|
9 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Mucositis/stomatitis (clinical exam) - Pharynx
|
8 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Mucositis/stomatitis (functional/symp) - Oral cav
|
6 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Mucositis/stomatitis (functional/symp) - Pharynx
|
10 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Nausea
|
32 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neutrophils/granulocytes (ANC/AGC)
|
67 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Opportunistic inf associated w/gt=Gr 2 lymphopenia
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Head/headache
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Joint
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Oral cavity
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain - Throat/pharynx/larynx
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain-Other (Specify)
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Phosphate, serum-low (hypophosphatemia)
|
25 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Platelets
|
70 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pneumonitis/pulmonary infiltrates
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Potassium, serum-low (hypokalemia)
|
13 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pruritus/itching
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Psychosis (hallucinations/delusions)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pulmonary hypertension
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Rash/desquamation
|
4 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
SVT and nodal arrhythmia - SVT tachycardia
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Thrombosis/thrombus/embolism
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Uric acid, serum-high (hyperuricemia)
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Vomiting
|
12 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Sodium, serum-low (hyponatremia)
|
11 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Syndromes-Other (Specify)
|
2 Participants
|
Adverse Events
High-dose Therapy Plus Tandem Transplant
Serious events: 2 serious events
Other events: 88 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High-dose Therapy Plus Tandem Transplant
n=90 participants at risk
Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
|
|---|---|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel
|
1.1%
1/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
1.1%
1/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
Other adverse events
| Measure |
High-dose Therapy Plus Tandem Transplant
n=90 participants at risk
Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
53.3%
48/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Blood and lymphatic system disorders
Hemoglobin
|
75.6%
68/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus bradycardia
|
6.7%
6/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Cardiac disorders
SVT and nodal arrhythmia - Sinus tachycardia
|
36.7%
33/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Eye disorders
Ocular/Visual-Other (Specify)
|
6.7%
6/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Constipation
|
25.6%
23/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Diarrhea
|
73.3%
66/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
10.0%
9/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
18.9%
17/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
15.6%
14/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Esophagitis
|
14.4%
13/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
6.7%
6/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify)
|
8.9%
8/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
34.4%
31/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.7%
6/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
31.1%
28/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
15.6%
14/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Nausea
|
91.1%
82/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
40.0%
36/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Pain - Oral cavity
|
23.3%
21/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Pain - Rectum
|
11.1%
10/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Pain - Stomach
|
12.2%
11/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Gastrointestinal disorders
Vomiting
|
78.9%
71/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
General disorders
Edema: head and neck
|
5.6%
5/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
General disorders
Edema: limb
|
24.4%
22/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
71.1%
64/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
40.0%
36/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
General disorders
Pain - Chest/thorax NOS
|
12.2%
11/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
General disorders
Pain - Face
|
7.8%
7/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
General disorders
Pain-Other (Specify)
|
38.9%
35/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
General disorders
Rigors/chills
|
42.2%
38/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
11.1%
10/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Infections and infestations
Infection-Other (Specify)
|
17.8%
16/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
54.4%
49/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Investigations
AST, SGOT
|
54.4%
49/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Investigations
Alkaline phosphatase
|
28.9%
26/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
6.7%
6/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Investigations
Cholesterol, serum-high (hypercholesterolemia)
|
7.8%
7/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Investigations
Creatinine
|
20.0%
18/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Investigations
GGT (gamma-glutamyl transpeptidase)
|
5.6%
5/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Investigations
Leukocytes (total WBC)
|
73.3%
66/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Investigations
Lymphopenia
|
58.9%
53/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Investigations
Metabolic/Laboratory-Other (Specify)
|
5.6%
5/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
76.7%
69/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Investigations
Platelets
|
83.3%
75/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Investigations
Weight gain
|
11.1%
10/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Investigations
Weight loss
|
23.3%
21/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
62.2%
56/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Metabolism and nutrition disorders
Anorexia
|
58.9%
53/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
41.1%
37/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
12.2%
11/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
60.0%
54/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Metabolism and nutrition disorders
Dehydration
|
7.8%
7/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
57.8%
52/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
6.7%
6/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
6.7%
6/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
31.1%
28/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Metabolism and nutrition disorders
Obesity
|
5.6%
5/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
53.3%
48/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
61.1%
55/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
47.8%
43/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
11.1%
10/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
10.0%
9/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
20.0%
18/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
28.9%
26/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
16.7%
15/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
11.1%
10/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
8.9%
8/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
12.2%
11/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
10.0%
9/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
7.8%
7/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Nervous system disorders
Dizziness
|
35.6%
32/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Nervous system disorders
Neuropathy: sensory
|
14.4%
13/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Nervous system disorders
Ocular/Visual-Other (Specify)
|
6.7%
6/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Nervous system disorders
Pain - Head/headache
|
55.6%
50/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
17.8%
16/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
14.4%
13/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Psychiatric disorders
Insomnia
|
47.8%
43/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Psychiatric disorders
Mood alteration - agitation
|
7.8%
7/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Psychiatric disorders
Mood alteration - anxiety
|
51.1%
46/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Psychiatric disorders
Mood alteration - depression
|
20.0%
18/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Renal and urinary disorders
Hemorrhage, GU - Urinary NOS
|
5.6%
5/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Renal and urinary disorders
Renal/Genitourinary-Other (Specify)
|
8.9%
8/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
5.6%
5/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Reproductive system and breast disorders
Hemorrhage, GU - Vagina
|
5.6%
5/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
23.3%
21/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
5.6%
5/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
36/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
22.2%
20/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
12.2%
11/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
10.0%
9/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
9/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis/stomatitis (clinical exam) - Pharynx
|
37.8%
34/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis/stomatitis (functional/symp) - Pharynx
|
26.7%
24/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
34.4%
31/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
14.4%
13/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other (Specify)
|
17.8%
16/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify)
|
28.9%
26/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.4%
13/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
34.4%
31/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
12.2%
11/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
18.9%
17/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
38.9%
35/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
6.7%
6/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
5.6%
5/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
15.6%
14/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Vascular disorders
Flushing
|
20.0%
18/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Vascular disorders
Hemorrhage/Bleeding-Other (Specify)
|
7.8%
7/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Vascular disorders
Hot flashes/flushes
|
6.7%
6/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Vascular disorders
Hypertension
|
16.7%
15/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
|
Vascular disorders
Hypotension
|
52.2%
47/90 • Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion
|
Additional Information
Lymphoma Committee Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place