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BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CTI BioPharma
ClinicalTrials.gov Identifier:
NCT00088530
First received: July 28, 2004
Last updated: April 27, 2017
Last verified: April 2017
Results First Received: March 11, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Lymphoma, Non-Hodgkin
Interventions: Drug: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone
Drug: Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled from 66 sites: 6 in the U.S, 4 in France, 3 in Bulgaria, 4 sites in Hungary, 3 in Ukraine, 11 in Italy, 2 in Romania, 3 in United Kingdom, 2 in Poland, 2 in Germany, 3 in Peru, 6 in Argentina, 1 in Colombia, 2 in Ecuador, 1 in Uruguay, 5 in Russia and 8 in India.

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
Experimental Group Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle)
Comparator Group Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab

Participant Flow:   Overall Study
    Experimental Group   Comparator Group
STARTED   70   70 
COMPLETED   20   16 
NOT COMPLETED   50   54 
Progressive/Relapsed Disease                28                39 
Adverse Event                15                9 
Withdrawal by Subject                2                5 
Lost to Follow-up                2                0 
Physician Decision                2                0 
Sponsor decision                0                1 
Patient never treated                1                0 



  Baseline Characteristics
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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
Experimental Group Pixantrone (BBR 2778) 85 mg/m2 on days 1, 8 and 15 of each 28-day cycle
Comparator Group Vinorelbine or Oxalplatin or Ifosfasmide or Etoposide or Mitoxatrone or Gemcitabine or Rituximab
Total Total of all reporting groups

Baseline Measures
   Experimental Group   Comparator Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 70   70   140 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Age at Randomization (years)   58.2  (13.5)   56.2  (12.9)   57.2  (13.2) 
Age, Customized 
[Units: Participants]
Count of Participants
     
18 to < 30   5   2   7 
30 to < 40   2   9   11 
40 to < 50   9   7   16 
50 to < 60   18   21   39 
60 to < 70   20   21   41 
70 to < 80   15   9   24 
≥ 80   1   1   2 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      24  34.3%      30  42.9%      54  38.6% 
Male      46  65.7%      40  57.1%      86  61.4% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Caucasian   46   44   90 
Black   0   0   0 
Asian   10   13   23 
Hispanic   7   6   13 
Native American   1   1   2 
Other   6   6   12 
Region of Enrollment [1] 
[Units: Participants]
     
North America   4   4   8 
Argentina   6   5   11 
Bulgaria   6   3   9 
Colombia   1   0   1 
Ecuador   3   4   7 
Hungary   5   5   10 
India   9   12   21 
Peru   9   8   17 
Poland   2   0   2 
Romania   1   1   2 
Russian Federation   4   5   9 
Ukraine   1   3   4 
Uruguay   0   1   1 
France   4   4   8 
United Kingdom   4   3   7 
Germany   3   0   3 
Italy   8   12   20 
[1] Demographic data will be displayed and summary statistics will be used to describe the study population (i.e., means, medians, and ranges of age, weight, and height, and frequencies for race, gender, baseline performance status, and tumor types and histology). No formal statistical tests will be done.
Baseline ECOG Performance Status [1] 
[Units: Participants]
Count of Participants
     
 26   23   49 
 30   32   62 
 14   14   28 
 0   1   1 
[1] Eastern Cooperative Oncology Group (ECOG) Performance Status Grade as published in Oken MM, et al. ECOG PS grade 0- Fully active, able to carry on all predisease performance without restriction; 1 - restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work; 2- ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3- capable of only limited self-care, confined to bed or chair more than 50% of waking hours.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Response (CR) and Complete Response Unconfirmed (CRu)   [ Time Frame: EOT; approximately 6 months ]

2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: 18 months after 6 cycles of treatment; approximately 24 months ]

3.  Secondary:   Overall Survival   [ Time Frame: 18 months after 6 cycles of treatment; approximately 24 months ]

4.  Secondary:   Overall Response Rate (ORR) Lasting at Least 4 Months   [ Time Frame: approximately 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Simran Bedi Singh
Organization: CTIBioPharma Corp.
phone: (206) 272-4000
e-mail: ssingh@ctibiopharma.com


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

Responsible Party: CTI BioPharma
ClinicalTrials.gov Identifier: NCT00088530     History of Changes
Obsolete Identifiers: NCT00101049
Other Study ID Numbers: PIX301
Study First Received: July 28, 2004
Results First Received: March 11, 2017
Last Updated: April 27, 2017