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

This study has been terminated.
(Slow accrual and futility)
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: January 11, 2017
Last verified: January 2017
  Purpose
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.

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: 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:


Further study details as provided by Philippe Armand, MD, PhD, Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 5
Study Start Date: February 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
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

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
Results First Received: October 4, 2016
Last Updated: January 11, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Philippe Armand, MD, PhD, 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
Gemcitabine
JM 3100
Doxorubicin
Etoposide
Cyclophosphamide
Melphalan
Busulfan
Liposomal doxorubicin
Etoposide phosphate
Prednisone
Vincristine
Lenograstim
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 27, 2017