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

Status:

COMPLETED

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

Lead Sponsor:

King's College Hospital NHS Trust

Conditions:

HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL)

Eligibility:

All Genders

18-75 years

Phase:

PHASE4

Brief Summary

The purpose of this study is to determine the safety of the combination of CHOP plus daclizumab in patients with ATLL previously untreated with anthracycline based chemotherapy.

Eligibility Criteria

Inclusion

Histologically confirmed ATLL requiring treatment
Frank acute leukaemia or lymphoma subtypes
Chronic and smouldering cases should be considered if they are symptomatic and require therapy, or there is evidence of disease progression
No previous treatment with anthracycline based cytotoxic chemotherapy
a. Patients may have received interferon and /or zidovudine and/or non-anthracycline based therapy
Age 18-75 years
Written informed consent

Exclusion

HIV 1 or 2 positivity
Pregnancy or breast-feeding
Concomitant chemo-radiotherapy
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
Other concomitant neoplasms not related to HTLV-I
Cardiac or respiratory insufficiency with an ECOG score of greater than 3
Any serious active uncontrolled infection

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01418430

Last Update

August 22 2011

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