Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual and futility
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| T-cell Non-Hodgkin Lymphoma | T-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Filgrastim | Drug | Filgrastim | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Palifermin | Drug | — | UNRESOLVED |
| Plerixafor | Drug |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CHOEP + High Dose Therapy + Auto SCT
- description
- 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).
- interventionNames
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available