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Alefacept in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma or Peripheral T-Cell Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00438802
First Posted: February 22, 2007
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
Results First Submitted: September 12, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphoma
Intervention: Drug: Alefacept

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dose Level 1

Starting Dose Level 1= 0.15 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >

> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks

Dose Level 2

Starting Dose Level 1= 0.20 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >

> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks

Dose Level 3

Starting Dose Level 1= 0.30 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >

> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks


Participant Flow:   Overall Study
    Dose Level 1   Dose Level 2   Dose Level 3
STARTED   6   8   9 
COMPLETED   6   8   9 
NOT COMPLETED   0   0   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
Dose Level 1

Starting Dose Level 1= 0.15 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >

> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks

Dose Level 2

Dose Level 2= 0.20 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >

> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks

Dose Level 3

Dose Level 3= 0.30 mg/kg > Each cycle is 4 weeks. > > Cycle 1 and 2: > Alefacept by IV Weekly >

> Cycles 3-12: > Alefacept by IV 1 x every 4 weeks

Total Total of all reporting groups

Baseline Measures
   Dose Level 1   Dose Level 2   Dose Level 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   8   9   23 
Age 
[Units: Years]
Median (Full Range)
 50.5 
 (46 to 80) 
 69 
 (48 to 80) 
 66 
 (56 to 76) 
 64 
 (46 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      4  66.7%      5  62.5%      3  33.3%      12  52.2% 
Male      2  33.3%      3  37.5%      6  66.7%      11  47.8% 
Region of Enrollment 
[Units: Participants]
       
United States   6   8   9   23 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Dose Limiting Toxicity (DLT)   [ Time Frame: 8 weeks from registration ]

2.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: 8 weeks from registration ]

3.  Secondary:   Clinical Response   [ Time Frame: up to 12 cycles (28 days per cycle) of treatment. ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Thomas E. Witzig, M.D.
Organization: Mayo Clinic
e-mail: witzig.thomas@mayo.edu



Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00438802     History of Changes
Other Study ID Numbers: CDR0000530071
P50CA097274 ( U.S. NIH Grant/Contract )
P30CA015083 ( U.S. NIH Grant/Contract )
LS058C ( Other Identifier: Mayo Clinic Cancer Center )
06-002246 ( Other Identifier: Mayo Clinic IRB )
First Submitted: February 20, 2007
First Posted: February 22, 2007
Results First Submitted: September 12, 2016
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017