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

This study is currently recruiting participants.
Verified February 2013 by Dana-Farber Cancer Institute
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: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
T-cell Non-Hodgkin Lymphoma
 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
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of CHOEP Induction Followed by Gemcitabine/Busulfan/Melphalan Autologous Stem Cell Transplantation for Patients With Newly Diagnosed T-Cell Lymphoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 24
Study Start Date: February 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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

Detailed Description:

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,

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746173

Contacts
Contact: Philippe Armand, MD 6176322305 parmand@partners.org

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Philippe Armand, MD     617-632-2305     parmand@partners.org    
Principal Investigator: Philippe Armand, MD            
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Philippe Armand, MD     617-632-2305     parmand@partners.org    
Principal Investigator: Philippe Armand, MD            
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Philippe Armand, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Philippe Armand, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01746173     History of Changes
Other Study ID Numbers: 12-388
Study First Received: December 4, 2012
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
T Cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Busulfan
Cyclophosphamide
Melphalan
Gemcitabine
Etoposide phosphate
Doxorubicin
 Etoposide
Prednisone
Vincristine
Lenograstim
JM 3100
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists

ClinicalTrials.gov processed this record on May 19, 2013