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A Study of Dulanermin in Combination With Rituximab in Subjects With Follicular and Other Low Grade, CD20+, Non-Hodgkin's Lymphomas

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ClinicalTrials.gov Identifier: NCT00400764
Recruitment Status : Terminated
First Posted : November 17, 2006
Results First Posted : October 7, 2011
Last Update Posted : November 23, 2011
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Genentech, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Hodgkin's Lymphoma
Interventions: Drug: Dulanermin
Drug: Rituximab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The Phase Ib part of this study was completed prior to the start of Phase II. Phase Ib participants were not eligible for participation in Phase II.

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
Phase Ib - Dulanermin 4 mg/kg Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Phase Ib - Dulanermin 8 mg/kg Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Phase II - Rituximab Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
Phase II - Combination Therapy Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Phase II - Dulanermin Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.

Participant Flow for 2 periods

Period 1:   Phase Ib
    Phase Ib - Dulanermin 4 mg/kg   Phase Ib - Dulanermin 8 mg/kg   Phase II - Rituximab   Phase II - Combination Therapy   Phase II - Dulanermin
STARTED   6   6   0   0   0 
Treated   6   6   0   0   0 
COMPLETED   0 [1]   2   0   0   0 
NOT COMPLETED   6   4   0   0   0 
Adverse Event                1                0                0                0                0 
Death                1                0                0                0                0 
Disease Progression                4                4                0                0                0 
[1] One patient reported as discontinued due to an AE should have been reported as death.

Period 2:   Phase II
    Phase Ib - Dulanermin 4 mg/kg   Phase Ib - Dulanermin 8 mg/kg   Phase II - Rituximab   Phase II - Combination Therapy   Phase II - Dulanermin
STARTED   0   0   23   26   11 
Treated   0   0   22 [1]   26   11 
COMPLETED   0   0   0   0   0 
NOT COMPLETED   0   0   23   26   11 
Death                0                0                1                2                0 
Lost to Follow-up                0                0                1                0                0 
Physician Decision                0                0                1                1                0 
Sponsor’s decision to terminate                0                0                18                22                11 
Patient began new, non-protocol, therapy                0                0                1                0                0 
Withdrawal by Subject                0                0                1                1                0 
[1] One patient in the Rituximab arm withdrew prior to treatment



  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
Phase Ib - Dulanermin 4 mg/kg Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Phase Ib - Dulanermin 8 mg/kg Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Phase II - Rituximab Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
Phase II - Combination Therapy Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
Phase II - Dulanermin Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
Total Total of all reporting groups

Baseline Measures
   Phase Ib - Dulanermin 4 mg/kg   Phase Ib - Dulanermin 8 mg/kg   Phase II - Rituximab   Phase II - Combination Therapy   Phase II - Dulanermin   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   22   26   11   71 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 56.3  (15.9)   63.7  (9.0)   NA [1]   NA [1]   NA [1]   60.0  (12.9) 
[1] Age demographic data for the Phase Ib population.
Age, Customized [1] 
[Units: Years]
Mean (Standard Deviation)
 NA [1]   NA [1]   58.0  (8.5)   58.4  (9.8)   61.4  (13.3)   58.8  (10.0) 
[1] Age demographic data for the Phase II population.
Gender 
[Units: Participants]
           
Female   1   1   9   7   2   20 
Male   5   5   13   19   9   51 


  Outcome Measures

1.  Primary:   Phase Ib: Number of Participants With a Dose-limiting Toxicity   [ Time Frame: The DLT assessment window was defined as the duration required to complete two full cycles of treatment with dulanermin (2 * 21 days) and four doses of rituximab (usually through Day 28). ]

2.  Primary:   Number of Participants With Treatment-Emergent Adverse Events by Severity Grade   [ Time Frame: From Baseline through Study Termination (up to a maximum of approximately 13 months for phase Ib and up to approximately 33 months for phase II) ]

3.  Primary:   Phase II: Objective Response as Assessed by the Independent Review Facility (IRF)   [ Time Frame: From Baseline through Study Termination (up to approximately 33 months) ]

4.  Primary:   Vital Signs: Change From Baseline in Diastolic and Systolic Blood Pressure at Treatment Termination Visit   [ Time Frame: Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms) ]

5.  Primary:   Vital Signs: Change From Baseline in Heart Rate at Treatment Termination Visit   [ Time Frame: Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms) ]

6.  Primary:   Vital Signs: Change From Baseline in Body Temperature at Treatment Termination Visit   [ Time Frame: Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms) ]

7.  Primary:   Number of Participants With a Clinically Significant Laboratory Abnormality   [ Time Frame: Baseline and Treatment Termination visit (8 weeks for Rituximab arm and 12 weeks for combination and Dulanermin arms). ]

8.  Primary:   Mean Serum Concentration of Dulanermin   [ Time Frame: Blood samples were taken 0.5, 1.5, 2, 3, 5, 7 and 24 hours after the start of the infusion on Day 1 of Cycle 1. ]

9.  Secondary:   Phase II: Progression Free Survival   [ Time Frame: From Baseline through Study Termination (up to approximately 33 months) ]

10.  Secondary:   Phase II: Overall Survival   [ Time Frame: From Baseline through Study Termination (up to approximately 33 months) ]

11.  Secondary:   Phase II: Objective Response as Assessed by the Investigator   [ Time Frame: From Baseline through Study Termination (up to approximately 33 months) ]

12.  Secondary:   Phase II: Duration of Response as Assessed by the Investigator   [ Time Frame: From Baseline through Study Termination (up to approximately 33 months) ]


  Serious Adverse Events


  Other Adverse Events


  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 Sponsor terminated the study on 5 May 2010, prior to the completion of the 36-month follow-up (FU) period, based on the primary analysis results. All patients were off-study or in survival FU (the treatment period was completed).


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00400764     History of Changes
Other Study ID Numbers: APO3585g
First Submitted: November 15, 2006
First Posted: November 17, 2006
Results First Submitted: September 1, 2011
Results First Posted: October 7, 2011
Last Update Posted: November 23, 2011