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HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL) Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab)


Phase 4
18 Years
75 Years
Not Enrolling
Both
HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL)

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Trial Information

HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL) Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab)


Inclusion Criteria:



1. Histologically confirmed ATLL requiring treatment

1. Frank acute leukaemia or lymphoma subtypes

2. Chronic and smouldering cases should be considered if they are symptomatic and
require therapy, or there is evidence of disease progression

2. No previous treatment with anthracycline based cytotoxic chemotherapy

a. Patients may have received interferon and /or zidovudine and/or non-anthracycline
based therapy

3. Age 18-75 years

4. Written informed consent

Exclusion Criteria:

1. HIV 1 or 2 positivity

2. Pregnancy or breast-feeding

3. Concomitant chemo-radiotherapy

4. Prior hepatic or renal insufficiency with a bilirubin or transaminases greater than 5
times the normal range or a creatinine greater than 150μmol/l (not related to
hypercalcaemia) following rehydration

5. Other concomitant neoplasms not related to HTLV-I

6. Cardiac or respiratory insufficiency with an ECOG score of greater than 3

7. Any serious active uncontrolled infection

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

CHOP-Z

NCT ID:

NCT01418430

Start Date:

Completion Date:

Related Keywords:

  • HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL)
  • Leukemia
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma

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