TerminatedPhase 2

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

Stopped: Slow accrual and futility

United States5 participantsStarted 2013-07

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

24-month Progression-Free Survival Rate

Timeframe: 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.

Trial details

NCT IDNCT01746173

SponsorDana-Farber Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-10

Results submitted2016-10-04