A Phase II Evaluation of High Dose Chemotherapy and Autologous Stem Cell Transplantation for Intestinal T-Cell Lymphomas
- To assess the efficacy and toxicity of intensive high-dose chemotherapy (alternating
I'VE regimen and intermediate-dose methotrexate) followed by autologous peripheral
blood stem cell transplantation for treatment of patients with intestinal T-cell
- To assess the toxicity of the regimen in a large population of these patients.
- To provide a coordinated approach to the treatment of these patients.
- To register patients unfit for the protocol chemotherapy into the pathological part of
OUTLINE: This is a multicenter study
- Chemotherapy: Patients receive CHOP chemotherapy comprising cyclophosphamide IV over 15
minutes, doxorubicin hydrochloride IV, and vincristine IV on day 1. Patients also
receive oral prednisolone on days 1-5.
After recovering from CHOP chemotherapy, patients receive I'VE chemotherapy comprising
epirubicin hydrochloride IV on day 1 and etoposide IV over 2 hours and ifosfamide IV
continuously on days 21-23. Patients also receive methotrexate IV over 24 hours on day 21.
Treatment repeats every 28 days for 3 courses in the absence of disease progression or
- Consolidation therapy: On day 77, stem cells are collected from patients if the marrow
is clear of disease. After completion of chemotherapy, patients in complete remission
receive carmustine IV on day 105, cytarabine IV and etoposide IV on days 106-109, and
melphalan IV on day 110. These patients undergo autologous peripheral blood stem cell
transplantation on day 112.
Prior to study treatment, patients undergo a biopsy of the gut to confirm diagnosis and a
blood sample is taken. Both blood and tissue samples may be used for further studies.
After recovery from treatment, patients are followed monthly for 4 months, then bimonthly
for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year,
and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Masking: Open Label, Primary Purpose: Treatment
Survival at 1 year
Sir James Spence Institute of Child Health at Royal Victoria Infirmary