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Trial record 4 of 62 for:    lymphoma OR CLL | GA101

Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma (PrE0401)

This study has been terminated.
(Closed due prolonged enrollment timelines)
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
PrECOG, LLC.
ClinicalTrials.gov Identifier:
NCT01889797
First received: June 26, 2013
Last updated: March 23, 2017
Last verified: March 2017
Results First Received: December 27, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Indolent Non-Hodgkin's Lymphoma
Interventions: Biological: Arm A: Rituximab
Biological: Arm B: GA101

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm A: Rituximab

Rituximab 375 mg/m² IV weekly for 4 weeks.

Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses.

Arm B: GA101

GA101 1,000 mg IV weekly for 4 weeks.

Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses.


Participant Flow:   Overall Study
    Arm A: Rituximab   Arm B: GA101
STARTED   16   16 
COMPLETED   16   16 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm A: Rituximab

Rituximab 375 mg/m² IV weekly for 4 weeks.

Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses.

Arm B: GA101

GA101 1,000 mg IV weekly for 4 weeks.

Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses.

Total Total of all reporting groups

Baseline Measures
   Arm A: Rituximab   Arm B: GA101   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   16   32 
Age 
[Units: Years]
Median (Full Range)
 52 
 (37 to 81) 
 59 
 (31 to 82) 
 56 
 (31 to 82) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10  62.5%      5  31.3%      15  46.9% 
Male      6  37.5%      11  68.8%      17  53.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      16 100.0%      16 100.0%      32 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   6.3%      0   0.0%      1   3.1% 
White      15  93.8%      16 100.0%      31  96.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   16   16   32 
ECOG Performance Status [1] 
[Units: Participants]
     
PS 0   12   12   24 
PS 1   4   4   8 
[1] The ECOG performance status (PS) measures how a disease impacts a patient’s daily living abilities. It describes a patient’s level of functioning in terms of their ability to care for themselves, daily & physical abilities. The PS score ranges from 0 to 5. A PS score of 0 indicates that a patient is fully active & able to carry out all pre-disease performance without restriction; 1 indicates that a patient is restricted in performance; 2 indicates ambulatory; & at the extreme, 5 indicates a patient is deceased. High score indicates the disease has a higher negative impact on living abilities.
Modified Ann Arbor Staging [1] 
[Units: Participants]
     
Stage III (1)   1   5   6 
Stage III (2)   5   4   9 
Stage IV   10   7   17 
[1] The Ann Arbor staging is used to describe the extent of non-Hodgkin lymphoma (NHL) in adults. There are 4 levels of the Ann Arbor staging system. Stage I means the lymphoma is only in 1 lymph node area or lymphoid organ; II indicates 2 or more groups of lymph nodes on the same side of the diaphragm; III indicates disease is present in lymph node areas on both sides of the diaphragm and may have spread to other organs; and IV shows that disease has spread outside the lymph system and also to the bone marrow, liver, brain, spinal cord or lungs. Higher grades are considered as worse.
Primary Tumor Type 
[Units: Participants]
     
Grade 1 Follicular NHL   10   13   23 
Grade 2 Follicular NHL   4   3   7 
Other   2   0   2 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Complete Response (CR) Rate   [ Time Frame: Re-staging (week 12, 13 or 14) and during follow-up if physician feels patient is subsequently in CR for up to 4 years ]

Measure Type Primary
Measure Title Complete Response (CR) Rate
Measure Description

Positron Emission Tomography (PET)-documented CR rates after induction therapy (weekly treatment x 4 weeks with GA101 or rituximab)

Definitions for clinical response are modified from the Revised Response Criteria for Malignant Lymphoma (Cheson BD, et al. Revised Response Criteria for Malignant Lymphoma. J Clin Oncol 2007; 25(5): 579-86). Lymph node measurements were taken from CT, CT portion of the PET/CT, or MRI scans where applicable. CR is defined as complete disappearance of all evidence of disease; PR as a >50% decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites; SD as failure to attain CR/PR or PD; and PD as any new lesion >1.5cm in any axis or ≥50% increase in previously involved sites.

Time Frame Re-staging (week 12, 13 or 14) and during follow-up if physician feels patient is subsequently in CR for up to 4 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants were included in the analysis

Reporting Groups
  Description
Arm A: Rituximab

Rituximab 375 mg/m² IV weekly for 4 weeks.

Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses.

Arm B: GA101

GA101 1,000 mg IV weekly for 4 weeks.

Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses.


Measured Values
   Arm A: Rituximab   Arm B: GA101 
Participants Analyzed 
[Units: Participants]
 16   16 
Complete Response (CR) Rate 
[Units: Percentage of participants]
Number (80% Confidence Interval)
 37.5 
 (21.0 to 56.5) 
 56.2 
 (37.5 to 73.7) 

No statistical analysis provided for Complete Response (CR) Rate



2.  Secondary:   PET Response Rate   [ Time Frame: Re-staging (week 12, 13 or 14) ]

Measure Type Secondary
Measure Title PET Response Rate
Measure Description PET response rate [PET-documented CR + Partial Response (PR)] based on PET scan results. Patients with unevaluable disease were included in the denominator.
Time Frame Re-staging (week 12, 13 or 14)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm A: Rituximab

Rituximab 375 mg/m² IV weekly for 4 weeks.

Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses.

Arm B: GA101

GA101 1,000 mg IV weekly for 4 weeks.

Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses.


Measured Values
   Arm A: Rituximab   Arm B: GA101 
Participants Analyzed 
[Units: Participants]
 16   16 
PET Response Rate 
[Units: Participants]
   
Complete Response   6   9 
Partial Response   5   5 
Stable Disease   3   2 
Progressive Disease   2   0 

No statistical analysis provided for PET Response Rate



3.  Secondary:   Overall Response Rate   [ Time Frame: Baseline and Re-staging (week 12, 13 or 14) ]

Measure Type Secondary
Measure Title Overall Response Rate
Measure Description Overall response rate (CR + PR by Cheson criteria) at re-staging (including bone marrow biopsy if CR suspected) by PET and Neck, Chest, Abdomen and Pelvic Computed Tomography (CT) scan. Patients with unevaluable disease were included in the denominator.
Time Frame Baseline and Re-staging (week 12, 13 or 14)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm A: Rituximab

Rituximab 375 mg/m² IV weekly for 4 weeks.

Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses.

Arm B: GA101

GA101 1,000 mg IV weekly for 4 weeks.

Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses.


Measured Values
   Arm A: Rituximab   Arm B: GA101 
Participants Analyzed 
[Units: Participants]
 16   16 
Overall Response Rate 
[Units: Percentage of participants]
Number (80% Confidence Interval)
 68.8 
 (49.6 to 83.9) 
 87.5 
 (70.0 to 96.6) 

No statistical analysis provided for Overall Response Rate



4.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Percent of participants alive and progression-free at 1 year ]

Measure Type Secondary
Measure Title Progression Free Survival (PFS)
Measure Description

CT scan every 3 months for 2 years, then every 6 months until progression. Compare PFS in each treatment arm.

Progressive disease (PD) was defined using Cheson criteria as described in the Primary Outcome section above. Progression-free survival (PFS) was defined as the time from start of treatment to the documentation of PD or death, whichever occurs first. Patients alive and without PD were censored at the date of last disease assessment.

Time Frame Percent of participants alive and progression-free at 1 year  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm A: Rituximab

Rituximab 375 mg/m² IV weekly for 4 weeks.

Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses.

Arm B: GA101

GA101 1,000 mg IV weekly for 4 weeks.

Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses.


Measured Values
   Arm A: Rituximab   Arm B: GA101 
Participants Analyzed 
[Units: Participants]
 16   16 
Progression Free Survival (PFS) 
[Units: Percentage of participants]
Number (80% Confidence Interval)
 68.8 
 (44.2 to 84.2) 
 87.5 
 (61.8 to 96.4) 

No statistical analysis provided for Progression Free Survival (PFS)




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study closed early due to slow accrual.


  More Information
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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:  
Name/Title: PrECOG Statistician
Organization: ECOG-ACRIN Biostatistics Center
phone: 617-632-3627
e-mail: jmanola@jimmy.harvard.edu


Publications:
Salles GA, et al. Efficacy and Safety of Obinutuzumab (GA101) Monotherapy in Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma: Results from a Phase I/II Study (BO20999) American Society of Hematology Annual meeting 2011 Abstract 268.


Responsible Party: PrECOG, LLC.
ClinicalTrials.gov Identifier: NCT01889797     History of Changes
Other Study ID Numbers: PrE0401
BO25454 ( Other Grant/Funding Number: Genentech )
Study First Received: June 26, 2013
Results First Received: December 27, 2016
Last Updated: March 23, 2017