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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
December 4, 2012
December 10, 2012
October 4, 2016
January 11, 2017
February 24, 2017
February 2013
October 2014   (Final data collection date for primary outcome measure)
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. ]
24-month progression-free survival rate is defined as the proportion of patients remaining alive and progression-free at 24 months from start of induction therapy. Disease progression was assessed using a combination of CT scans and PET scans. Progression was categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007).
24 month progression-free survival [ Time Frame: 2 years ]
To estimate the proportion of patients alive and progression-free after 24 months after the beginning of CHOEP + Gem/Bu/Mel HDT/ASCT among patients younger than 70 years old with untreated TCL
Complete list of historical versions of study NCT01746173 on ClinicalTrials.gov Archive Site
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). ]
Induction response is the defined as the proportion of patients who achieve complete remission (CR) or partial remission (PR) during 6 cycles of induction therapy. Reponse was assessed was using a combination of CT scans and PET scans. Partial and complete response were categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). Given the cycle length of 3 weeks, induction duration per protocol was 18 weeks.
  • Response rate [ Time Frame: 2 years ]
    To estimate the response rate (completed remission [CR] and partial remission [PR]) after CHOEP x 6 and after Gem/Bu/Mel ASCT
  • Overall survival [ Time Frame: 2 years ]
    Overall survival of patients at 2 years
  • Grade 3 and above toxicity related to study regimen [ Time Frame: 2 years ]
    To estimate the toxicity (grade 3 and above) with this regimen using CTCAE v4.0. All grade 3 and above adverse events, and all serious adverse events will be recorded. This will be reported as number of events and as number of patients with events for all events of interest.
  • Stem cell mobilization rate [ Time Frame: 6 months ]
    To estimate the rate of successful stem cell mobilization after CHOEP in responding patients.
  • Proportion of patients who successfully complete regimen [ Time Frame: 2 years ]
    To estimate the proportion of patients who can successfully complete the entire treatment regimen
  • Engraftment time [ Time Frame: 6 months ]
    To estimate the time to engraftment of neutrophil and platelet engraftment after ASCT
  • Relapse [ Time Frame: 2 years ]
    To estimate the cumulative incidence of relapse at 24 months
  • Treatment-related mortality [ Time Frame: 2 years ]
    To estimate the cumulative incidence of treatment-related mortality at 24 months
Not Provided
Not Provided
 
CHOEP + High Dose Therapy + Auto SCT for T-Cell Lymphoma
A Phase II Study of CHOEP Induction Followed by Gemcitabine/Busulfan/Melphalan Autologous Stem Cell Transplantation for Patients With Newly Diagnosed T-Cell Lymphoma
The current standard of care for the frontline treatment of peripheral T-cell lymphomas (PTCL) is induction chemotherapy followed by autologous stem cell transplantation (ASCT). However, many patients are unable to get to ASCT or relapse after ASCT, with a poor prognosis. Recently, a novel ASCT conditioning regimen of gemcitabine, busulfan and melphalan (Gem/Bu/Mel) has been reported to lead to favorable outcomes in this disease. We therefore designed a frontline regimen of CHOEP induction followed by Gem/Bu/Mel ASCT, and report the results of a phase 2 study of this regimen in patients with PTCL.

Objectives:

Primary

  • To estimate the proportion of patients alive and progression-free at 24 months after beginning induction therapy

Secondary

  • To estimate the response rate (complete remission (CR) and partial remission (PR)) after CHOEP x 6 and after Gem/Bu/Mel ASCT
  • To estimate overall survival (OS), progression-free survival (PFS), cumulative incidence of relapse (CIR), and non-relapse mortality (NRM)
  • To estimate the toxicity (grade 3 and above)
  • To estimate the rate of successful stem cell mobilization after CHOEP in responding patients
  • To estimate the proportion of patients who can successfully complete the entire treatment regimen
  • To estimate the time to engraftment of neutrophil and platelet engraftment after ASCT
  • To determine whether tumor DNA can be detected in peripheral blood of patients before therapy
  • To evaluate the changes and prognostic relevance in detectable tumor DNA in peripheral blood after induction chemotherapy (CHOEP) and after Gem/Bu/Mel ASCT
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
T-cell Non-Hodgkin Lymphoma
  • Drug: Cyclophosphamide
    Other Name: cytoxan
  • Drug: Doxorubicin
    Other Name: adriamycin
  • Drug: Vincristine
    Other Name: oncovin
  • Drug: Etoposide
    Other Names:
    • Etopophos
    • Toposar
    • Etoposide phosphate
  • Drug: Prednisone
  • Drug: Filgrastim
    Other Names:
    • neupogen
    • G-CSF
  • Drug: Plerixafor
    Other Name: mozobil
  • Procedure: Stem Cell Collection
    Other Name: Leukapheresis
  • Drug: Palifermin
    Other Names:
    • KGF
    • kepivance
  • Drug: Gemcitabine
    Other Name: gemzaar
  • Drug: Busulfan
    Other Name: busulfex
  • Drug: Melphalan
  • Procedure: Stem Cell Transplant
    Other Name: Stem Cell Infusion
Experimental: 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).
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
October 2014
October 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of T-Cell lymphoma with mandatory pathologic review at Brigham and Women's Hospital or Massachusetts General Hospital
  • Measurable disease
  • Candidate for Autologous Stem Cell Transplant

Exclusion Criteria:

  • Prior anti-lymphoma chemotherapy (except steroids/radiotherapy for urgent palliation, one prior cycle of CHOP or up to 2 prior cycles of CHOEP)
  • Pregnant or breastfeeding
  • Alk-positive ACL
  • Significant neuropathy precluding vincristine administration
  • Known hypersensitivity to any of the agents used in the treatment
  • Uncontrolled intercurrent illness
  • Receiving other investigational agents
  • History of a different malignancy except if disease free for at least 5 years or have cervical cancer in situ or basal cell/squamous cell carcinoma of the skin
  • HIV positive on anti-retroviral therapy
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01746173
12-388
Yes
Not Provided
Plan to Share IPD: No
Philippe Armand, MD, PhD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
Principal Investigator: Philippe Armand, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP