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CHOEP + High Dose Therapy + Auto SCT for T-Cell Lymphoma

This study has been terminated.
(Slow accrual and futility)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01746173
First Posted: December 10, 2012
Last Update Posted: February 24, 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.
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Philippe Armand, MD, PhD, Dana-Farber Cancer Institute
Results First Submitted: October 4, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: T-cell Non-Hodgkin Lymphoma
Interventions: Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Etoposide
Drug: Prednisone
Drug: Filgrastim
Drug: Plerixafor
Procedure: Stem Cell Collection
Drug: Palifermin
Drug: Gemcitabine
Drug: Busulfan
Drug: Melphalan
Procedure: Stem Cell Transplant

  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
5 patients were enrolled between July 2013 and January 2014.

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
CHOEP + High Dose Therapy + Auto SCT Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).

Participant Flow:   Overall Study
    CHOEP + High Dose Therapy + Auto SCT
STARTED   5 
COMPLETED   3 
NOT COMPLETED   2 
Disease Progression                2 



  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.
The analysis dataset is comprised of all enrolled patients.

Reporting Groups
  Description
CHOEP + High Dose Therapy + Auto SCT Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).

Baseline Measures
   CHOEP + High Dose Therapy + Auto SCT 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Years]
Mean (Full Range)
 55 
 (39 to 69) 
Gender 
[Units: Participants]
Count of Participants
 
Female      2  40.0% 
Male      3  60.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   5 
Stage [1] 
[Units: Participants]
Count of Participants
 
Stage I   1 
Stage II   0 
Stage III   2 
Stage IV   2 
[1] Stage per Ann Arbor Classification


  Outcome Measures
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1.  Primary:   24-month Progression-Free Survival Rate   [ Time Frame: Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24. ]

2.  Secondary:   Induction Response   [ Time Frame: Disease was re-staged at cycles 3 and 6 during induction. Median duration of induction therapy in this study cohort was 6 cycles/18 weeks (range 2-6 cycles). ]


  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
The trial closed early due to poor accrual. The small sample size precludes definitive conclusions.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Philippe Armand MD, PhD
Organization: Dana-Farber Cancer Institute
phone: 617.632.2305
e-mail: Philippe_Armand@dfci.harvard.edu



Responsible Party: Philippe Armand, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01746173     History of Changes
Other Study ID Numbers: 12-388
First Submitted: December 4, 2012
First Posted: December 10, 2012
Results First Submitted: October 4, 2016
Results First Posted: January 11, 2017
Last Update Posted: February 24, 2017