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Trial record 31 of 534 for:    cutaneous [CONDITION] AND "lymphoma "[CONDITION]

Everolimus in Treating Cutaneous T-cell Lymphoma (CTCL)

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ClinicalTrials.gov Identifier: NCT01637090
Recruitment Status : Terminated (Poor enrollment)
First Posted : July 10, 2012
Results First Posted : October 31, 2016
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Adam Lerner, Boston Medical Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cutaneous T-Cell Lymphoma
Intervention: Drug: Everolimus

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was actively recruiting from within the investigator's own praceice from June 2012 through May 2015 in the hematology/oncology multidisciplinary clinic.

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
All Patients on Study

Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.

This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.

Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity.


Participant Flow:   Overall Study
    All Patients on Study
STARTED   3 
COMPLETED   0 
NOT COMPLETED   3 



  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
All Patients on Study

Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.

This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.

Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity.


Baseline Measures
   All Patients on Study 
Overall Participants Analyzed 
[Units: Participants]
 3 
Age [1] 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      1  33.3% 
>=65 years      2  66.7% 
[1] greater than or equal to 18 years
Gender 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      3 100.0% 


  Outcome Measures

1.  Primary:   Efficacy of Treatment   [ Time Frame: 12 months after beginning treatment ]

2.  Secondary:   Time to Response   [ Time Frame: three months ]

3.  Secondary:   Progression-free Survival   [ Time Frame: two years after discontinuing study treatment ]

4.  Secondary:   Number of Participants With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: Up to one year ]

5.  Secondary:   Effect of mTOR on Tumors   [ Time Frame: one year ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Adam Lerner, MD
Organization: Boston Medical Center
phone: 617-638-8265
e-mail: adam.lerner@bmc.org



Responsible Party: Adam Lerner, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01637090     History of Changes
Other Study ID Numbers: H-30213
First Submitted: April 2, 2012
First Posted: July 10, 2012
Results First Submitted: September 12, 2016
Results First Posted: October 31, 2016
Last Update Posted: January 12, 2017