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S1106 Rituximab With Combination Chemotherapy or Bendamustine Hydrochloride Followed by Consolidation Chemotherapy and Stem Cell Transplantation in Older Patients With Previously Untreated Mantle Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT01412879
Recruitment Status : Active, not recruiting
First Posted : August 9, 2011
Results First Posted : June 7, 2017
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Interventions Biological: rituximab
Drug: bendamustine hydrochloride
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: methotrexate
Drug: vincristine sulfate
Enrollment 53
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy) Arm 2: R-Bendamustine (Induction Therapy) Consolidation Therapy: Stem Cell Transplant
Hide Arm/Group Description The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days). R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.

Patients receive stem cell transplant with non-TBI containing regimen (BCV or BEAM Chemotherapy) for patients 61 years or older or TBI-containing regimen (TBI/VP-16/Cyclophosphamide). BCV chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2. BEAM chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.

TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2. * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0.

Period Title: Initial Registration (Induction Therapy)
Started 18 35 0
Treatment Started 17 35 0
Completed 5 27 0
Not Completed 13 8 0
Reason Not Completed
Adverse Event             5             3             0
Refusal Unrelated to Adverse Event             1             3             0
Progression/Relapse             0             1             0
Reasons not Protocol Specified             6             1             0
Treatment not Given             1             0             0
Period Title: Consolidation Therapy
Started 0 0 26 [1]
Completed 0 0 26
Not Completed 0 0 0
[1]
Only eligible patients who are able to have stem cell harvested receive consolidation therapy.
Arm/Group Title Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy) Arm 2: R-Bendamustine (Induction Therapy) Total
Hide Arm/Group Description The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days). R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment. Total of all reporting groups
Overall Number of Baseline Participants 17 35 52
Hide Baseline Analysis Population Description
All eligible patients who started treatment were included in the analysis
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants 35 participants 52 participants
58.8
(43.6 to 65.7)
56.6
(33.0 to 64.1)
57.2
(33.0 to 65.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 35 participants 52 participants
Female
8
  47.1%
3
   8.6%
11
  21.2%
Male
9
  52.9%
32
  91.4%
41
  78.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 35 participants 52 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
16
  94.1%
35
 100.0%
51
  98.1%
Unknown or Not Reported
1
   5.9%
0
   0.0%
1
   1.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 35 participants 52 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.9%
0
   0.0%
1
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.9%
2
   5.7%
3
   5.8%
White
13
  76.5%
32
  91.4%
45
  86.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
  11.8%
1
   2.9%
3
   5.8%
1.Primary Outcome
Title Progression-Free Survival (PFS) at 2 Years
Hide Description Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started treatment were included in the analysis
Arm/Group Title Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy) Arm 2: R-Bendamustine (Induction Therapy)
Hide Arm/Group Description:
The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
Overall Number of Participants Analyzed 17 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
82
(53.0 to 93.7)
81
(62.7 to 91.1)
2.Secondary Outcome
Title Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hide Description Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time Frame Up to 8 months (Assessed at the beginning of each cycle of treatment, at restaging, and at post transplant.)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
Arm/Group Title R-HCVAD/MTX/Ara-C (Induction Therapy) R-Bendamustine (Induction Therapy) Stem Cell Transplant (Consolidation Therapy)
Hide Arm/Group Description:
The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.

Patients receive stem cell transplant with non-TBI containing regimen (BCV or BEAM Chemotherapy) for patients 61 years or older or TBI-containing regimen (TBI/VP-16/Cyclophosphamide). BCV chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2. BEAM chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.

TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2. * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0.

Overall Number of Participants Analyzed 17 35 26
Measure Type: Number
Unit of Measure: Participants
Acidosis 0 0 1
Adult respiratory distress syndrome 0 0 1
Alanine aminotransferase increased 1 0 0
Anemia 10 3 9
Anorexia 0 0 1
Arthralgia 0 1 0
Aspartate aminotransferase increased 1 0 0
Blood bilirubin increased 0 0 2
CD4 lymphocytes decreased 2 2 0
Catheter related infection 1 1 1
Dehydration 1 0 0
Device related infection 0 0 1
Diarrhea 1 0 4
Enterocolitis 0 0 1
Enterocolitis infectious 0 1 1
Epistaxis 1 0 0
Fatigue 0 1 0
Febrile neutropenia 5 5 13
Gallbladder infection 0 0 1
Hyperglycemia 2 0 0
Hypoalbuminemia 0 1 0
Hypocalcemia 0 0 2
Hypokalemia 5 2 1
Hypomagnesemia 0 0 1
Hyponatremia 0 0 1
Hypophosphatemia 4 1 3
Hypotension 0 0 1
Hypoxia 0 0 1
Infections and infestations - Other, specify 0 1 0
Infusion related reaction 0 1 0
Lung infection 0 0 1
Lymphocyte count decreased 10 27 12
Myalgia 0 1 0
Nausea 1 0 2
Neutrophil count decreased 11 12 16
Pain in extremity 0 1 0
Platelet count decreased 12 6 19
Pruritus 0 1 0
Rash maculo-papular 1 1 1
Rectal hemorrhage 0 0 1
Small intestinal obstruction 0 0 1
Sore throat 0 1 0
Syncope 1 0 0
Tumor pain 0 1 0
Urinary tract infection 0 1 0
Vascular access complication 0 1 0
Vomiting 0 0 1
White blood cell decreased 10 14 20
3.Secondary Outcome
Title Response Rate (Complete and Partial Response)
Hide Description Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. 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. 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. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.
Time Frame Up to 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started treatment were included in the analysis.
Arm/Group Title Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy) Arm 2: R-Bendamustine (Induction Therapy)
Hide Arm/Group Description:
The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
Overall Number of Participants Analyzed 17 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
94.1
(71.3 to 99.9)
82.9
(66.4 to 93.4)
4.Secondary Outcome
Title 5-year Overall Survival (OS)
Hide Description Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started treatment were included in the analysis.
Arm/Group Title Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy) Arm 2: R-Bendamustine (Induction Therapy)
Hide Arm/Group Description:
The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
Overall Number of Participants Analyzed 17 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81
(50.6 to 93.3)
79
(57.1 to 90.1)
Time Frame Up to 8 months (assessed at the beginning of each cycle of treatment, at restaging, and at post transplant).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title R-HCVAD/MTX/Ara-C (Induction Therapy) R-Bendamustine (Induction Therapy) Stem Cell Transplant (Consolidation Therapy)
Hide Arm/Group Description The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days). R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.

Patients receive stem cell transplant with non-TBI containing regimen (BCV or BEAM Chemotherapy) for patients 61 years or older or TBI-containing regimen (TBI/VP-16/Cyclophosphamide). BCV chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2. BEAM chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.

TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2. * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0.

All-Cause Mortality
R-HCVAD/MTX/Ara-C (Induction Therapy) R-Bendamustine (Induction Therapy) Stem Cell Transplant (Consolidation Therapy)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
R-HCVAD/MTX/Ara-C (Induction Therapy) R-Bendamustine (Induction Therapy) Stem Cell Transplant (Consolidation Therapy)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/35 (0.00%)   1/26 (3.85%) 
Gastrointestinal disorders       
Diarrhea   0/17 (0.00%)  0/35 (0.00%)  1/26 (3.85%) 
Infections and infestations       
Enterocolitis infectious   0/17 (0.00%)  0/35 (0.00%)  1/26 (3.85%) 
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome   0/17 (0.00%)  0/35 (0.00%)  1/26 (3.85%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
R-HCVAD/MTX/Ara-C (Induction Therapy) R-Bendamustine (Induction Therapy) Stem Cell Transplant (Consolidation Therapy)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/17 (100.00%)   35/35 (100.00%)   26/26 (100.00%) 
Blood and lymphatic system disorders       
Anemia   15/17 (88.24%)  25/35 (71.43%)  21/26 (80.77%) 
Febrile neutropenia   5/17 (29.41%)  5/35 (14.29%)  13/26 (50.00%) 
Cardiac disorders       
Pericardial effusion   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Sinus bradycardia   1/17 (5.88%)  3/35 (8.57%)  1/26 (3.85%) 
Sinus tachycardia   3/17 (17.65%)  3/35 (8.57%)  2/26 (7.69%) 
Ear and labyrinth disorders       
Ear pain   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Tinnitus   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Eye disorders       
Blurred vision   0/17 (0.00%)  3/35 (8.57%)  1/26 (3.85%) 
Conjunctivitis   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Dry eye   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Watering eyes   0/17 (0.00%)  0/35 (0.00%)  2/26 (7.69%) 
Gastrointestinal disorders       
Abdominal distension   0/17 (0.00%)  2/35 (5.71%)  1/26 (3.85%) 
Abdominal pain   2/17 (11.76%)  2/35 (5.71%)  3/26 (11.54%) 
Anal pain   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Bloating   3/17 (17.65%)  0/35 (0.00%)  0/26 (0.00%) 
Constipation   12/17 (70.59%)  16/35 (45.71%)  4/26 (15.38%) 
Diarrhea   8/17 (47.06%)  10/35 (28.57%)  20/26 (76.92%) 
Dry mouth   0/17 (0.00%)  1/35 (2.86%)  2/26 (7.69%) 
Duodenal ulcer   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Dyspepsia   2/17 (11.76%)  3/35 (8.57%)  1/26 (3.85%) 
Dysphagia   1/17 (5.88%)  1/35 (2.86%)  1/26 (3.85%) 
Gastroesophageal reflux disease   1/17 (5.88%)  3/35 (8.57%)  2/26 (7.69%) 
Gastrointestinal disorders-Other   1/17 (5.88%)  1/35 (2.86%)  0/26 (0.00%) 
Hemorrhoidal hemorrhage   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Hemorrhoids   2/17 (11.76%)  1/35 (2.86%)  1/26 (3.85%) 
Mucositis oral   7/17 (41.18%)  2/35 (5.71%)  13/26 (50.00%) 
Nausea   9/17 (52.94%)  22/35 (62.86%)  19/26 (73.08%) 
Rectal pain   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Small intestinal obstruction   0/17 (0.00%)  0/35 (0.00%)  2/26 (7.69%) 
Vomiting   4/17 (23.53%)  8/35 (22.86%)  9/26 (34.62%) 
General disorders       
Chills   2/17 (11.76%)  4/35 (11.43%)  1/26 (3.85%) 
Edema face   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Edema limbs   2/17 (11.76%)  4/35 (11.43%)  5/26 (19.23%) 
Facial pain   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Fatigue   11/17 (64.71%)  33/35 (94.29%)  15/26 (57.69%) 
Fever   0/17 (0.00%)  9/35 (25.71%)  4/26 (15.38%) 
Infusion related reaction   3/17 (17.65%)  4/35 (11.43%)  0/26 (0.00%) 
Irritability   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Non-cardiac chest pain   1/17 (5.88%)  2/35 (5.71%)  0/26 (0.00%) 
Pain   1/17 (5.88%)  6/35 (17.14%)  0/26 (0.00%) 
Immune system disorders       
Allergic reaction   0/17 (0.00%)  3/35 (8.57%)  0/26 (0.00%) 
Cytokine release syndrome   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Infections and infestations       
Catheter related infection   1/17 (5.88%)  1/35 (2.86%)  1/26 (3.85%) 
Infections and infestations-Other   1/17 (5.88%)  5/35 (14.29%)  0/26 (0.00%) 
Lung infection   0/17 (0.00%)  0/35 (0.00%)  2/26 (7.69%) 
Skin infection   0/17 (0.00%)  2/35 (5.71%)  2/26 (7.69%) 
Upper respiratory infection   0/17 (0.00%)  3/35 (8.57%)  0/26 (0.00%) 
Injury, poisoning and procedural complications       
Bruising   1/17 (5.88%)  2/35 (5.71%)  0/26 (0.00%) 
Investigations       
Alanine aminotransferase increased   8/17 (47.06%)  8/35 (22.86%)  7/26 (26.92%) 
Alkaline phosphatase increased   3/17 (17.65%)  7/35 (20.00%)  4/26 (15.38%) 
Aspartate aminotransferase increased   4/17 (23.53%)  9/35 (25.71%)  6/26 (23.08%) 
Blood bilirubin increased   1/17 (5.88%)  7/35 (20.00%)  5/26 (19.23%) 
CD4 lymphocytes decreased   2/17 (11.76%)  2/35 (5.71%)  0/26 (0.00%) 
Carbon monoxide diffusing capacity decreased   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Cholesterol high   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Creatinine increased   1/17 (5.88%)  3/35 (8.57%)  2/26 (7.69%) 
Electrocardiogram QT corrected interval prolonged   1/17 (5.88%)  1/35 (2.86%)  0/26 (0.00%) 
INR increased   0/17 (0.00%)  0/35 (0.00%)  2/26 (7.69%) 
Lymphocyte count decreased   11/17 (64.71%)  29/35 (82.86%)  14/26 (53.85%) 
Neutrophil count decreased   11/17 (64.71%)  18/35 (51.43%)  18/26 (69.23%) 
Platelet count decreased   15/17 (88.24%)  23/35 (65.71%)  19/26 (73.08%) 
Weight gain   1/17 (5.88%)  3/35 (8.57%)  2/26 (7.69%) 
Weight loss   1/17 (5.88%)  4/35 (11.43%)  3/26 (11.54%) 
White blood cell decreased   11/17 (64.71%)  24/35 (68.57%)  20/26 (76.92%) 
Metabolism and nutrition disorders       
Anorexia   6/17 (35.29%)  12/35 (34.29%)  12/26 (46.15%) 
Dehydration   1/17 (5.88%)  1/35 (2.86%)  1/26 (3.85%) 
Hyperglycemia   9/17 (52.94%)  14/35 (40.00%)  8/26 (30.77%) 
Hyperkalemia   0/17 (0.00%)  2/35 (5.71%)  0/26 (0.00%) 
Hypernatremia   1/17 (5.88%)  4/35 (11.43%)  2/26 (7.69%) 
Hypertriglyceridemia   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Hyperuricemia   1/17 (5.88%)  4/35 (11.43%)  2/26 (7.69%) 
Hypoalbuminemia   9/17 (52.94%)  7/35 (20.00%)  11/26 (42.31%) 
Hypocalcemia   8/17 (47.06%)  8/35 (22.86%)  17/26 (65.38%) 
Hypoglycemia   0/17 (0.00%)  3/35 (8.57%)  1/26 (3.85%) 
Hypokalemia   7/17 (41.18%)  7/35 (20.00%)  9/26 (34.62%) 
Hypomagnesemia   1/17 (5.88%)  2/35 (5.71%)  5/26 (19.23%) 
Hyponatremia   5/17 (29.41%)  8/35 (22.86%)  6/26 (23.08%) 
Hypophosphatemia   5/17 (29.41%)  3/35 (8.57%)  4/26 (15.38%) 
Obesity   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia   3/17 (17.65%)  6/35 (17.14%)  1/26 (3.85%) 
Back pain   3/17 (17.65%)  7/35 (20.00%)  1/26 (3.85%) 
Bone pain   1/17 (5.88%)  7/35 (20.00%)  0/26 (0.00%) 
Generalized muscle weakness   3/17 (17.65%)  2/35 (5.71%)  2/26 (7.69%) 
Myalgia   1/17 (5.88%)  5/35 (14.29%)  0/26 (0.00%) 
Neck pain   0/17 (0.00%)  2/35 (5.71%)  0/26 (0.00%) 
Pain in extremity   0/17 (0.00%)  7/35 (20.00%)  2/26 (7.69%) 
Nervous system disorders       
Cognitive disturbance   1/17 (5.88%)  1/35 (2.86%)  0/26 (0.00%) 
Dizziness   3/17 (17.65%)  5/35 (14.29%)  0/26 (0.00%) 
Dysgeusia   2/17 (11.76%)  3/35 (8.57%)  4/26 (15.38%) 
Headache   6/17 (35.29%)  6/35 (17.14%)  3/26 (11.54%) 
Nervous system disorders-Other   0/17 (0.00%)  2/35 (5.71%)  0/26 (0.00%) 
Peripheral motor neuropathy   2/17 (11.76%)  0/35 (0.00%)  0/26 (0.00%) 
Peripheral sensory neuropathy   4/17 (23.53%)  2/35 (5.71%)  3/26 (11.54%) 
Presyncope   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Seizure   0/17 (0.00%)  2/35 (5.71%)  0/26 (0.00%) 
Syncope   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Psychiatric disorders       
Agitation   0/17 (0.00%)  3/35 (8.57%)  0/26 (0.00%) 
Anxiety   3/17 (17.65%)  6/35 (17.14%)  1/26 (3.85%) 
Depression   1/17 (5.88%)  2/35 (5.71%)  0/26 (0.00%) 
Insomnia   3/17 (17.65%)  6/35 (17.14%)  3/26 (11.54%) 
Renal and urinary disorders       
Proteinuria   1/17 (5.88%)  1/35 (2.86%)  1/26 (3.85%) 
Urinary frequency   0/17 (0.00%)  3/35 (8.57%)  1/26 (3.85%) 
Urinary incontinence   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Urinary urgency   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis   0/17 (0.00%)  2/35 (5.71%)  2/26 (7.69%) 
Cough   2/17 (11.76%)  11/35 (31.43%)  4/26 (15.38%) 
Dyspnea   2/17 (11.76%)  5/35 (14.29%)  1/26 (3.85%) 
Epistaxis   4/17 (23.53%)  1/35 (2.86%)  0/26 (0.00%) 
Hiccups   1/17 (5.88%)  1/35 (2.86%)  1/26 (3.85%) 
Nasal congestion   0/17 (0.00%)  2/35 (5.71%)  1/26 (3.85%) 
Pleural effusion   1/17 (5.88%)  1/35 (2.86%)  0/26 (0.00%) 
Productive cough   0/17 (0.00%)  2/35 (5.71%)  0/26 (0.00%) 
Sinus disorder   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Sore throat   3/17 (17.65%)  2/35 (5.71%)  1/26 (3.85%) 
Skin and subcutaneous tissue disorders       
Alopecia   8/17 (47.06%)  3/35 (8.57%)  7/26 (26.92%) 
Dry skin   0/17 (0.00%)  4/35 (11.43%)  0/26 (0.00%) 
Nail ridging   1/17 (5.88%)  2/35 (5.71%)  0/26 (0.00%) 
Pain of skin   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Pruritus   2/17 (11.76%)  3/35 (8.57%)  2/26 (7.69%) 
Rash acneiform   1/17 (5.88%)  1/35 (2.86%)  0/26 (0.00%) 
Rash maculo-papular   3/17 (17.65%)  9/35 (25.71%)  2/26 (7.69%) 
Scalp pain   1/17 (5.88%)  0/35 (0.00%)  0/26 (0.00%) 
Skin and subcutaneous tissue disorders - Other   0/17 (0.00%)  4/35 (11.43%)  1/26 (3.85%) 
Vascular disorders       
Flushing   1/17 (5.88%)  0/35 (0.00%)  1/26 (3.85%) 
Hot flashes   0/17 (0.00%)  3/35 (8.57%)  0/26 (0.00%) 
Hypertension   2/17 (11.76%)  11/35 (31.43%)  5/26 (19.23%) 
Hypotension   2/17 (11.76%)  6/35 (17.14%)  6/26 (23.08%) 
Thromboembolic event   1/17 (5.88%)  1/35 (2.86%)  1/26 (3.85%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lymphoma Committee Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4623
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01412879     History of Changes
Other Study ID Numbers: CDR0000707601
S1106 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: August 6, 2011
First Posted: August 9, 2011
Results First Submitted: February 15, 2017
Results First Posted: June 7, 2017
Last Update Posted: April 4, 2019