Know Cancer

forgot password

A Phase II Evaluation of High Dose Chemotherapy and Autologous Stem Cell Transplantation for Intestinal T-Cell Lymphomas

Phase 2
18 Years
Open (Enrolling)
Lymphoma, Small Intestine Cancer

Thank you

Trial Information

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
the study.

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
unacceptable toxicity.

- 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.

Inclusion Criteria


- Newly confirmed diagnosis of intestinal T-cell lymphoma/ enteropathy-type T-cell
lymphoma according to the following WHO classifications:

- Usual phenotype CD3-, CD7-positive; CD5-, CD4-, CD8-negative; or CD30-positive

- Complete surgical resection allowed


- Unsupported neutrophils ≥ 1,500/mm^3 unless attributed to lymphomatous bone marrow

- Unsupported platelets ≥ 100,000/mm^3 unless attributed to lymphomatous bone marrow

- Creatinine clearance ≥ 50 mL/min

- Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)

- Bilirubin ≤ 2.5 times ULN

- Left ventricular ejection fraction ≥ 50%

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for ≥ 1 month after
completion of study treatment

- Patients with any serious concomitant medical or psychiatric condition that would
preclude them tolerating the planned treatment should be entered into the
registration study only

- No known hepatitis B, hepatitis C, or HIV positivity

- No active uncontrolled cardiovascular disease

- No abnormal EKG if there is a previous history of cardiac problems

- No other severe impairment of cardiac function

- No active malignancy within the past 5 years except cervical intraepithelial
neoplasia or localized skin cancer


- See Disease Characteristics

- Prior diagnostic or emergency surgical procedures allowed

- More than 5 years since prior treatment for malignancy

- No prior chemotherapy or radiotherapy for treatment of lymphoma

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival at 1 year

Safety Issue:


Principal Investigator

Anne Lennard

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sir James Spence Institute of Child Health at Royal Victoria Infirmary



Study ID:




Start Date:

February 2008

Completion Date:

Related Keywords:

  • Lymphoma
  • Small Intestine Cancer
  • small intestine lymphoma
  • stage I adult T-cell leukemia/lymphoma
  • stage II adult T-cell leukemia/lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • Lymphoma
  • Lymphoma, T-Cell
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms
  • Enteropathy-Associated T-Cell Lymphoma