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Multicenter Trial to Treat Patients With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT00884286
Recruitment Status : Completed
First Posted : April 20, 2009
Results First Posted : March 29, 2018
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
PharmaMar

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Intervention: Drug: Aplidin®

  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
Aplidin® (Cohort Non-cutaneous PTCL)

Aplidin® given as a 1-hour weekly IV infusion

Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.

Aplidin®(Other Lymphoma)

Aplidin® given as a 1-hour weekly IV infusion

Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.


Participant Flow:   Overall Study
    Aplidin® (Cohort Non-cutaneous PTCL)   Aplidin®(Other Lymphoma)
STARTED   34   33 
COMPLETED   2   0 
NOT COMPLETED   32   33 
Progressive disease                21                28 
Toxicity                4                1 
Death                2                2 
Physician Decision                1                0 
Septic shock                1                0 
Thrombus in right auricle                1                0 
Not treated                2                1 
Comprised lung carcinoma                0                1 



  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
Aplidin® (Cohort Non-cutaneous)

Aplidin® given as a 1-hour weekly IV infusion

Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.

Aplidin® (Cohort Other Lymphoma)

Aplidin® given as a 1-hour weekly IV infusion

Aplidin®: Aplidin® will be administered at a starting dose of 3.2 mg/m2, as a 1-hour intravenous infusion, on days 1, 8 and 15, every 28 days cycle.

Total Total of all reporting groups

Baseline Measures
   Aplidin® (Cohort Non-cutaneous)   Aplidin® (Cohort Other Lymphoma)   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   33   67 
Age, Customized [1] 
[Units: Participants]
Count of Participants
     
17 years   0   1   1 
Between 18 and 49 years   14   3   17 
Between 50 and 69 years   14   19   33 
>= 70 years   6   10   16 
[1] A 17 year-old patient was included and it was considered by the Sponsor as a non-clinically relevant protocol deviation.
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      24  70.6%      22  66.7%      46  68.7% 
Male      10  29.4%      11  33.3%      21  31.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
Italy   3   0   3 
France   20   23   43 
Switzerland   2   1   3 
Peru   2   0   2 
Spain   7   9   16 


  Outcome Measures

1.  Primary:   Objective Response Rate   [ Time Frame: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first ]

2.  Secondary:   Time to Response Onset   [ Time Frame: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first ]

3.  Secondary:   Duration of Response   [ Time Frame: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first ]

4.  Secondary:   Time to Progression   [ Time Frame: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first ]

5.  Secondary:   Time to Subsequent Chemotherapy   [ Time Frame: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first ]

6.  Secondary:   Progression-free Survival   [ Time Frame: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first ]

7.  Secondary:   Overall Survival   [ Time Frame: All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first ]


  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
No text entered.


  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 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: Clinical Development Department of PharmaMar´s Oncology,Business Unit.,
Organization: Pharma Mar, S.A.
phone: +34 918466000
e-mail: clinicaltrials@pharmamar.com


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

Responsible Party: PharmaMar
ClinicalTrials.gov Identifier: NCT00884286     History of Changes
Other Study ID Numbers: APL-B-013-02
First Submitted: April 17, 2009
First Posted: April 20, 2009
Results First Submitted: January 29, 2018
Results First Posted: March 29, 2018
Last Update Posted: April 25, 2018