Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fludarabine, Bendamustine, and Rituximab (FBR) for Relapsed Chronic Lymphocytic Leukemia (CLL)

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: NCT01096992
Recruitment Status : Completed
First Posted : March 31, 2010
Results First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Drug: Bendamustine
Drug: Fludarabine
Drug: Rituximab
Enrollment 51
Recruitment Details Recruitment Period: 4/2010 to 012/2013
Pre-assignment Details  
Arm/Group Title Phase 1 20 mg/m^2 Phase 1 30 mg/m^2 Phase 1 40 mg/m^2 Phase 1 50 mg/m^2 Phase 2
Hide Arm/Group Description

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: 20 mg/m^2 IV on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: 30 mg/m^2 IV on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: 40 mg/m^2 IV on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: 50 mg/m^2 IV on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Bendamustine 30 mg/m^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab

Phase 2: 30 mg/m^2 by vein (fixed) on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Period Title: Overall Study
Started 6 3 6 6 30
Completed 6 3 6 6 30
Not Completed 0 0 0 0 0
Arm/Group Title Phase 1 20 mg/m^2 Phase 1 30 mg/m^2 Phase 1 40 mg/m^2 Phase 1 50 mg/m^2 Phase 2 Total
Hide Arm/Group Description

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: 20 mg/m^2 IV on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: 30 mg/m^2 IV on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: 40 mg/m^2 IV on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: 50 mg/m^2 IV on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Bendamustine 30 mg/m^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab

Phase 2: 30 mg/m^2 by vein (fixed) on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Total of all reporting groups
Overall Number of Baseline Participants 6 3 6 6 30 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 6 participants 6 participants 30 participants 51 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  66.7%
2
  66.7%
4
  66.7%
4
  66.7%
21
  70.0%
35
  68.6%
>=65 years
2
  33.3%
1
  33.3%
2
  33.3%
2
  33.3%
9
  30.0%
16
  31.4%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 3 participants 6 participants 6 participants 30 participants 51 participants
63
(46 to 82)
64
(62 to 66)
63
(49 to 76)
62
(55 to 76)
61
(46 to 73)
62
(46 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 6 participants 6 participants 30 participants 51 participants
Female
2
  33.3%
2
  66.7%
1
  16.7%
0
   0.0%
8
  26.7%
13
  25.5%
Male
4
  66.7%
1
  33.3%
5
  83.3%
6
 100.0%
22
  73.3%
38
  74.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 6 participants 6 participants 30 participants 51 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  16.7%
0
   0.0%
0
   0.0%
1
  16.7%
2
   6.7%
4
   7.8%
White
5
  83.3%
3
 100.0%
6
 100.0%
5
  83.3%
27
  90.0%
46
  90.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.3%
1
   2.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 3 participants 6 participants 6 participants 30 participants 51 participants
6
 100.0%
3
 100.0%
6
 100.0%
6
 100.0%
30
 100.0%
51
 100.0%
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)
Hide Description MTD defined as highest dose level in which 6 participants have been treated with </= to 1 patient experiencing dose limiting toxicity (DLT). MTD exceeded if 2 or more of 6 patients experience grade 3 or higher, non-hematologic, non-infusion related toxicity a major organ system. DLT defined as treatment-related, grade >/= 3 non-hematologic toxicity. Hematologic toxicity grade >/= 3 that lasts longer than 42 days considered a DLT. Hematologic toxicity graded according to the 2008 IWCLL criteria for grading. Tumor lysis not considered a DLT.
Time Frame After 4 week cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Maximum Tolerated Dose (MTD) was not established as an objective for the phase II portion of this study and was not collected.
Arm/Group Title Phase 1
Hide Arm/Group Description:

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: Starting Dose of 20 mg/m2 IV on Days 1,2,3 (after fludarabine)

Phase 2: 30 mg/m2 by vein (fixed) on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m2 IV, Day 1

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: mg/m^2
30
2.Secondary Outcome
Title Overall Response Rate of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)
Hide Description Overall Response is Complete response (CR) + Partial response (PR). Overall response evaluated by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 for complete or partial response and progressive disease. Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; positive or negative minimal residual disease (MRD); Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts;
Time Frame Overall response assessed 2 months after 6th or last course if participants not able to receive all 6 intended courses of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants in the phase II portion of the study were not evaluable for response due to loss to follow-up.
Arm/Group Title Phase 1 20 mg/m^2 Phase 1 30 mg/m^2 Phase 1 40 mg/m^2 Phase 1 50 mg/m^2 Phase 2
Hide Arm/Group Description:

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: 20 mg/m^2 IV on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: 30 mg/m^2 IV on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: 40 mg/m^2 IV on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: 50 mg/m^2 IV on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Bendamustine 30 mg/m^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab

Phase 2: 30 mg/m^2 by vein (fixed) on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Overall Number of Participants Analyzed 6 3 6 6 28
Measure Type: Count of Participants
Unit of Measure: Participants
5
  83.3%
3
 100.0%
5
  83.3%
2
  33.3%
17
  60.7%
Time Frame Adverse events captured from the time of participant consent until 30 days after the last dose of drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1 20 mg/m^2 Phase 1 30 mg/m^2 Phase 1 40 mg/m^2 Phase 1 50 mg/m^2 Phase 2
Hide Arm/Group Description

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: 20 mg/m^2 IV on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: 30 mg/m^2 IV on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: 40 mg/m^2 IV on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Bendamustine, Fludarabine + Rituximab

Bendamustine: Phase 1: 50 mg/m^2 IV on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

Bendamustine 30 mg/m^2 by vein (fixed), Days 1,2,3 + Fludarabine + Rituximab

Phase 2: 30 mg/m^2 by vein (fixed) on Days 1,2,3 (after fludarabine)

Fludarabine: Course 1: 20 mg/m^2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m^2 IV, Days 1,2,3

Rituximab: Course 1: 375 mg/m^2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m^2 IV, Day 1

All-Cause Mortality
Phase 1 20 mg/m^2 Phase 1 30 mg/m^2 Phase 1 40 mg/m^2 Phase 1 50 mg/m^2 Phase 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/6 (33.33%)      0/3 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      1/30 (3.33%)    
Show Serious Adverse Events Hide Serious Adverse Events
Phase 1 20 mg/m^2 Phase 1 30 mg/m^2 Phase 1 40 mg/m^2 Phase 1 50 mg/m^2 Phase 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/6 (66.67%)      0/3 (0.00%)      4/6 (66.67%)      5/6 (83.33%)      16/30 (53.33%)    
Blood and lymphatic system disorders           
Hemolysis  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/30 (3.33%)  1
Neutropenia  1  1/6 (16.67%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/30 (3.33%)  1
Elevated BUN  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/30 (0.00%)  0
Hemorrhage  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/30 (0.00%)  0
Hemorrhage Bladder  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/30 (0.00%)  0
Subdural Hematoma  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/30 (0.00%)  0
Thrombocytopenia  1  1/6 (16.67%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/30 (0.00%)  0
Cardiac disorders           
Hypotension  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/30 (0.00%)  0
Gastrointestinal disorders           
Anorexia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/30 (3.33%)  1
Dehydration  1  2/6 (33.33%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/30 (6.67%)  2
Nausea and Vomiting  1  3/6 (50.00%)  4 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 2/30 (6.67%)  2
Acites  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/30 (0.00%)  0
General disorders           
Amloidosis  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/30 (3.33%)  1
Fainting  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/30 (3.33%)  1
Fall  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/30 (3.33%)  1
Fatigue  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/30 (3.33%)  1
Pain  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/30 (3.33%)  1
Chills  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/30 (0.00%)  0
Fever  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/30 (0.00%)  0
Growth Neck  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/30 (0.00%)  0
Infections and infestations           
Cellulitis  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/30 (3.33%)  1
Infection  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/30 (3.33%)  1
Neutropenic Fever  1  1/6 (16.67%)  1 0/3 (0.00%)  0 2/6 (33.33%)  4 1/6 (16.67%)  1 6/30 (20.00%)  7
Pneumonia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 3/30 (10.00%)  3
Bladder Infection  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/30 (0.00%)  0
Sepsis  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/30 (0.00%)  0
Urinary Tract Infection  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/30 (0.00%)  0
Investigations           
Drug Rash  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/30 (3.33%)  2
Tumor Flare  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/30 (3.33%)  1
Allergic Reaction Investigational Product  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/30 (0.00%)  0
Metabolism and nutrition disorders           
Tumor Lysis  1  0/6 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 1/6 (16.67%)  1 3/30 (10.00%)  3
Hyperphosphatemia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/30 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Gout  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/30 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Squamous Cell Carcinoma  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/30 (0.00%)  0
Renal and urinary disorders           
Renal Failure  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/30 (0.00%)  0
Skin and subcutaneous tissue disorders           
Rash  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/30 (3.33%)  1
Vascular disorders           
Phlebitis  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/30 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0)
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%
Phase 1 20 mg/m^2 Phase 1 30 mg/m^2 Phase 1 40 mg/m^2 Phase 1 50 mg/m^2 Phase 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      3/3 (100.00%)      6/6 (100.00%)      6/6 (100.00%)      30/30 (100.00%)    
Blood and lymphatic system disorders           
Neutropenia  1  0/6 (0.00%)  0 2/3 (66.67%)  2 4/6 (66.67%)  4 3/6 (50.00%)  3 23/30 (76.67%)  33
Hyperglycemia  1  2/6 (33.33%)  2 3/3 (100.00%)  3 0/6 (0.00%)  0 2/6 (33.33%)  2 30/30 (100.00%)  30
Thrombocytopenia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 15/30 (50.00%)  32
Anemia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 7/30 (23.33%)  7
Cardiac disorders           
Atrial Fibrillation  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/30 (6.67%)  2
Gastrointestinal disorders           
Dehydration  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 3/30 (10.00%)  3
Nausea  1  4/6 (66.67%)  4 3/3 (100.00%)  3 3/6 (50.00%)  3 2/6 (33.33%)  2 18/30 (60.00%)  18
Vomiting  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 3/6 (50.00%)  3 2/30 (6.67%)  2
Anorexia  1  1/6 (16.67%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 3/6 (50.00%)  3 3/30 (10.00%)  3
General disorders           
Fatigue  1  1/6 (16.67%)  1 1/3 (33.33%)  1 2/6 (33.33%)  2 3/6 (50.00%)  3 30/30 (100.00%)  30
Edema  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 2/30 (6.67%)  2
Infections and infestations           
Infection  1  0/6 (0.00%)  0 0/3 (0.00%)  0 4/6 (66.67%)  4 4/6 (66.67%)  4 10/30 (33.33%)  17
Metabolism and nutrition disorders           
Tumor Lysis  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 2/30 (6.67%)  2
Vascular disorders           
Deep Vein Thrombosis  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 4/30 (13.33%)  4
1
Term from vocabulary, CTCAE (3.0)
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: William Wierda, MD./Professor
Organization: The University of Texas MD Anderson Cancer Center
Phone: 713-745-0428
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01096992     History of Changes
Other Study ID Numbers: 2009-0546
NCI-2011-01942 ( Registry Identifier: NCI CTRP )
First Submitted: March 30, 2010
First Posted: March 31, 2010
Results First Submitted: April 24, 2018
Results First Posted: September 25, 2019
Last Update Posted: September 25, 2019