Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab)

Launched by KING'S COLLEGE HOSPITAL NHS TRUST · Aug 16, 2011

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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