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Trial record 9 of 179 for:    LENALIDOMIDE AND Leukemia

Lenalidomide + Plerixafor in Previously Treated Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT01373229
Recruitment Status : Completed
First Posted : June 14, 2011
Results First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Collaborators:
Celgene Corporation
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
David Rizzieri, MD, Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia, Lymphocytic, Chronic, B-Cell
Intervention Drug: Lenalidomide + Plerixafor (+ Rituximab)
Enrollment 21
Recruitment Details Subjects were recruited from the CLL clinic at Duke Medical Center from January 2012 to December 2013.
Pre-assignment Details 21 subjects were consented to this study. Six (6) were screen failures; therefore, only 15 subjects began the treatment regimen which included a lenalidomide run-in phase. Three (3) subjects were unable to complete the run-in phase. Three (3) subjects died prior to completing stage 2, and so were not evaluable for DLT.
Arm/Group Title Lenalidomide + Plerixafor+ Rituximab
Hide Arm/Group Description
  1. Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.
  2. Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.
  3. Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.
  4. Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:

    • Cohort 1: 0.24 mg/kg
    • Cohort 2: 0.32 mg/kg
  5. Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.
  6. Subjects will then continue single agent lenalidomide until disease progression.
Period Title: Overall Study
Started 15
Completed 9
Not Completed 6
Reason Not Completed
Death             3
Physician Decision             3
Arm/Group Title Lenalidomide + Plerixafor+ Rituximab
Hide Arm/Group Description
  1. Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.
  2. Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.
  3. Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.
  4. Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:

    • Cohort 1: 0.24 mg/kg
    • Cohort 2: 0.32 mg/kg
  5. Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.
  6. Subjects will then continue single agent lenalidomide until disease progression.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  73.3%
>=65 years
4
  26.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
4
  26.7%
Male
11
  73.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
15
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   6.7%
White
14
  93.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Maximum Tolerated Dose
Hide Description [Not Specified]
Time Frame 4-16 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide + Plerixafor+ Rituximab
Hide Arm/Group Description:
  1. Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.
  2. Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.
  3. Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.
  4. Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:

    • Cohort 1: 0.24 mg/kg
    • Cohort 2: 0.32 mg/kg
  5. Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.
  6. Subjects will then continue single agent lenalidomide until disease progression.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: mg/kg
0.24
2.Secondary Outcome
Title Overall Response (Complete Response/Partial Response)
Hide Description

NCI 96 Response Criteria

CR (Complete Response):

Lymphadenopathy = none > 1.5cm Hepatomegaly = none Splenomegaly = none Blood lymphocytes = <4000 per microliter Marrow = normocellular, <30% lymphocytes, no B-lymphoid nodules. Platelet count = >100,000 per microliter Hemoglobin = >11.0 grams per deciliter Neutrophils = >1500 per microliter

PR (Partial Response):

Lymphadenopathy = Decrease >/= 50% Hepatomegaly = Decrease >/= 50% Splenomegaly = Decrease >/= 50% Blood lymphocytes = Decrease >/= 50% from baseline Marrow = 50% reduction in marrow infiltrate or B-lymphoid nodules. Platelet count = >100,000 per microliter or increase >/= 50% over baseline Hemoglobin = >11.0 grams per deciliter or increase >/= 50% over baseline Neutrophils = >1500 per microliter or increase >/= 50% over baseline

Time Frame at the end of 4 months of combination treatment and at 2 months after completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Three (3) subjects were unable to complete the run-in phase. Three (3) subjects died prior to completing stage 2, and three (3) subjects were unable to complete 4 cycles of combination therapy. Therefore, only 6 subjects were analyzed for response.
Arm/Group Title Lenalidomide + Plerixafor+ Rituximab
Hide Arm/Group Description:
  1. Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.
  2. Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.
  3. Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.
  4. Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:

    • Cohort 1: 0.24 mg/kg
    • Cohort 2: 0.32 mg/kg
  5. Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.
  6. Subjects will then continue single agent lenalidomide until disease progression.
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description [Not Specified]
Time Frame time from day 1 of treatment to disease progression, death, or 2 years, whichever comes first
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who experienced disease progression
Arm/Group Title Lenalidomide + Plerixafor+ Rituximab
Hide Arm/Group Description:
  1. Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.
  2. Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.
  3. Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.
  4. Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:

    • Cohort 1: 0.24 mg/kg
    • Cohort 2: 0.32 mg/kg
  5. Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.
  6. Subjects will then continue single agent lenalidomide until disease progression.
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: months
11  (1)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame the time from day 1 of treatment to death or 2 years, whichever comes first
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who died on study
Arm/Group Title Lenalidomide + Plerixafor+ Rituximab
Hide Arm/Group Description:
  1. Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.
  2. Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.
  3. Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.
  4. Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:

    • Cohort 1: 0.24 mg/kg
    • Cohort 2: 0.32 mg/kg
  5. Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.
  6. Subjects will then continue single agent lenalidomide until disease progression.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: months
5.5  (10)
5.Secondary Outcome
Title Reduction in Severity of B Symptoms
Hide Description Reduction in the severity of the following B symptoms will be assessed: fever ≥ 101F, chills, night sweats, and anorexia with weight loss.
Time Frame at the end of stage 1 (lenalidomide alone), at the end of stage 2 (4 months of combination), and at 2 months post-completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and the Outcome will never be analyzed
Arm/Group Title Lenalidomide + Plerixafor+ Rituximab
Hide Arm/Group Description:
  1. Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.
  2. Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.
  3. Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.
  4. Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:

    • Cohort 1: 0.24 mg/kg
    • Cohort 2: 0.32 mg/kg
  5. Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.
  6. Subjects will then continue single agent lenalidomide until disease progression.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Reduction in the Frequency of Blood and Platelet Transfusions
Hide Description The change in number of transfusions from pre- to post-treatment will be calculated and summarized across all patients by giving the minimum, the 25th, 50th (median) and the 75th percentile and the maximum.
Time Frame 4 weeks prior to therapy and in the 4 weeks following the completion of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and the Outcome will never be analyzed
Arm/Group Title Lenalidomide + Plerixafor+ Rituximab
Hide Arm/Group Description:
  1. Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.
  2. Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.
  3. Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.
  4. Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:

    • Cohort 1: 0.24 mg/kg
    • Cohort 2: 0.32 mg/kg
  5. Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.
  6. Subjects will then continue single agent lenalidomide until disease progression.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide + Plerixafor+ Rituximab
Hide Arm/Group Description
  1. Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.
  2. Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.
  3. Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.
  4. Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:

    • Cohort 1: 0.24 mg/kg
    • Cohort 2: 0.32 mg/kg
  5. Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.
  6. Subjects will then continue single agent lenalidomide until disease progression.
All-Cause Mortality
Lenalidomide + Plerixafor+ Rituximab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide + Plerixafor+ Rituximab
Affected / at Risk (%) # Events
Total   14/15 (93.33%)    
Blood and lymphatic system disorders   
Anemia * 1  1/15 (6.67%)  1
Febrile neutropenia * 1  2/15 (13.33%)  2
Hemolysis * 1  1/15 (6.67%)  1
Gastrointestinal disorders   
Abdominal pain * 1  1/15 (6.67%)  1
General disorders   
Death NOS * 1  1/15 (6.67%)  1
Fever * 1  1/15 (6.67%)  1
Infections and infestations   
Infections and infestations - Other, specify * 1  1/15 (6.67%)  1
Sepsis * 1  2/15 (13.33%)  2
Investigations   
Platelet count decreased * 1  1/15 (6.67%)  1
White blood cell decreased * 1  1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/15 (6.67%)  1
Nervous system disorders   
Dysphasia * 1  1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  3/15 (20.00%)  3
Vascular disorders   
Hypotension * 1  1/15 (6.67%)  1
Thromboembolic event * 1  1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lenalidomide + Plerixafor+ Rituximab
Affected / at Risk (%) # Events
Total   14/15 (93.33%)    
Blood and lymphatic system disorders   
Anemia * 1  13/15 (86.67%)  14
Blood and lymphatic system disorders - Other, specify * 1  1/15 (6.67%)  2
Lymph node pain * 1  1/15 (6.67%)  1
Ear and labyrinth disorders   
Ear and labyrinth disorders - Other, specify * 1  1/15 (6.67%)  1
Hearing impaired * 1  1/15 (6.67%)  1
Eye disorders   
Blurred vision * 1  1/15 (6.67%)  1
Dry eye * 1  1/15 (6.67%)  1
Eye disorders - Other, specify * 1  1/15 (6.67%)  1
Gastrointestinal disorders   
Abdominal pain * 1  1/15 (6.67%)  1
Anal ulcer * 1  1/15 (6.67%)  1
Constipation * 1  3/15 (20.00%)  3
Diarrhea * 1  4/15 (26.67%)  6
Dry mouth * 1  3/15 (20.00%)  3
Dyspepsia * 1  1/15 (6.67%)  2
Flatulence * 1  1/15 (6.67%)  1
Gastrointestinal disorders - Other, specify * 1  3/15 (20.00%)  3
Nausea * 1  5/15 (33.33%)  5
Stomach pain * 1  1/15 (6.67%)  1
Vomiting * 1  1/15 (6.67%)  1
General disorders   
Chills * 1  1/15 (6.67%)  1
Edema limbs * 1  5/15 (33.33%)  5
Fatigue * 1  9/15 (60.00%)  12
Fever * 1  3/15 (20.00%)  4
General disorders and administration site conditions - Other, specify * 1  4/15 (26.67%)  5
Pain * 1  3/15 (20.00%)  3
Immune system disorders   
Allergic reaction * 1  1/15 (6.67%)  1
Cytokine release syndrome * 1  1/15 (6.67%)  1
Infections and infestations   
Infections and infestations - Other, specify * 1  1/15 (6.67%)  1
Sinusitis * 1  4/15 (26.67%)  4
Skin infection * 1  1/15 (6.67%)  1
Investigations   
Creatinine increased * 1  2/15 (13.33%)  2
Neutrophil count decreased * 1  13/15 (86.67%)  27
Platelet count decreased * 1  11/15 (73.33%)  16
Weight loss * 1  2/15 (13.33%)  2
Metabolism and nutrition disorders   
Anorexia * 1  7/15 (46.67%)  7
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  2/15 (13.33%)  2
Back pain * 1  2/15 (13.33%)  2
Chest wall pain * 1  1/15 (6.67%)  1
Generalized muscle weakness * 1  2/15 (13.33%)  2
Joint range of motion decreased * 1  1/15 (6.67%)  1
Myalgia * 1  1/15 (6.67%)  1
Nervous system disorders   
Concentration impairment * 1  1/15 (6.67%)  1
Dysgeusia * 1  1/15 (6.67%)  1
Extrapyramidal disorder * 1  1/15 (6.67%)  1
Headache * 1  2/15 (13.33%)  2
Paresthesia * 1  1/15 (6.67%)  2
Psychiatric disorders   
Agitation * 1  1/15 (6.67%)  1
Depression * 1  1/15 (6.67%)  1
Insomnia * 1  2/15 (13.33%)  2
Renal and urinary disorders   
Urinary frequency * 1  2/15 (13.33%)  4
Urinary urgency * 1  1/15 (6.67%)  1
Reproductive system and breast disorders   
Reproductive system and breast disorders - Other, specify * 1  1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders   
Cough * 1  7/15 (46.67%)  7
Dyspnea * 1  4/15 (26.67%)  4
Hoarseness * 1  1/15 (6.67%)  1
Nasal congestion * 1  5/15 (33.33%)  6
Respiratory, thoracic and mediastinal disorders - Other, specify * 1  2/15 (13.33%)  2
Skin and subcutaneous tissue disorders   
Dry skin * 1  1/15 (6.67%)  1
Pruritus * 1  2/15 (13.33%)  2
Rash maculo-papular * 1  3/15 (20.00%)  4
Skin and subcutaneous tissue disorders - Other, specify * 1  1/15 (6.67%)  2
Vascular disorders   
Hot flashes * 1  3/15 (20.00%)  3
Hypotension * 1  1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Danielle Brander, MD
Organization: Duke University Medical Center
Phone: 919-286-6897
EMail: danielle.brander@duke.edu
Layout table for additonal information
Responsible Party: David Rizzieri, MD, Duke University
ClinicalTrials.gov Identifier: NCT01373229     History of Changes
Other Study ID Numbers: Pro00026715
RV0622 ( Other Identifier: Celgene )
First Submitted: June 12, 2011
First Posted: June 14, 2011
Results First Submitted: January 25, 2017
Results First Posted: February 5, 2018
Last Update Posted: February 5, 2018