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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Philippe Armand, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01746173
First received: December 4, 2012
Last updated: July 24, 2014
Last verified: July 2014

December 4, 2012
July 24, 2014
February 2013
February 2015   (final data collection date for primary outcome measure)
24 month progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01746173 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Overall survival of patients at 2 years
  • Grade 3 and above toxicity related to study regimen [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To estimate the proportion of patients who can successfully complete the entire treatment regimen
  • Engraftment time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To estimate the time to engraftment of neutrophil and platelet engraftment after ASCT
  • Relapse [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To estimate the cumulative incidence of relapse at 24 months
  • Treatment-related mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To estimate the cumulative incidence of treatment-related mortality at 24 months
Same as current
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

This is a phase II study of CHOEP induction chemotherapy followed by autologous stem cell transplant using gemcitabine/busulfan/melphalan conditioning in patients with newly diagnosed systemic T-cell non-Hodgkin lymphoma.

This is a phase II study of CHOEP (cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone)induction chemotherapy followed by autologous stem cell transplant using gemcitabine/busulfan/melphalan conditioning in patients with newly diagnosed systemic T-cell non-Hodgkin lymphoma. The study treatment comprises 6 cycles of CHOEP, followed (for responding patients) by stem cell mobilization and harvesting (using neupogen +/- plerixafor) followed by high dose therapy and autologous stem cell transplantation,

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
T-cell Non-Hodgkin Lymphoma
  • Drug: Cyclophosphamide
    Intravenous, on Day 1, 3 or 6 cycles
    Other Name: cytoxan
  • Drug: Doxorubicin
    Intravenously, on Day 1, 3 or 6 cycles
    Other Name: adriamycin
  • Drug: Vincristine
    Intravenously, on Day 1, 3 or 6 cycles
    Other Name: oncovin
  • Drug: Etoposide
    Intravenously or orally, Day 1,2 and 3, 3 or 6 cycles
  • Drug: Prednisone
    Taken orally, days 1-5
  • Drug: Filgrastim
    Subcutaneous daily injection for 5-7 days
    Other Names:
    • neupogen
    • G-CSF
  • Drug: Plerixafor
    daily subcutaneous injections for 0-2 days
    Other Name: mozobil
  • Procedure: Stem Cell Collection
    Leukapheresis used to collect stem cells from peripheral blood
    Other Name: Leukapheresis
  • Drug: Palifermin
    Daily intravenous infusion
    Other Names:
    • KGF
    • kepivance
  • Drug: Gemcitabine
    intravenous infusion for 2 days
    Other Name: gemzaar
  • Drug: Busulfan
    intravenous infusion for 4 days
    Other Name: busulfex
  • Drug: Melphalan
    intravenous infusion for 2 days
  • Procedure: Stem Cell Transplant
    Reinfusion of stored peripheral blood stem cells
    Other Name: Stem Cell Infusion
Experimental: Experimental Arm
Induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone Stem Cell Mobilization/Harvest: filgrastim +/- plerixafor Stem Cell Collection by leukapheresis Conditioning Chemotherapy: gemcitabine, busulfan, melphalan, with palifermin support Autologous stem cell transplantation
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.
 
Active, not recruiting
24
September 2016
February 2015   (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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01746173
12-388
Yes
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
July 2014

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