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A Phase II Study of CHOEP Induction Followed by Gemcitabine/Busulfan/Melphalan Autologous Stem Cell Transplantation for Patients With Newly Diagnosed T-Cell Lymphoma


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
T-cell Non-Hodgkin Lymphoma

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Trial Information

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 (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,


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

24 month progression-free survival

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Philippe Armand, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

12-388

NCT ID:

NCT01746173

Start Date:

February 2013

Completion Date:

September 2016

Related Keywords:

  • T-cell Non-Hodgkin Lymphoma
  • T Cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell

Name

Location
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115