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Completed

NCT Number: NCT01418430

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

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.

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Key information

Conditions

HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

CHOP-daclizumab

Drug

Other names: CHOP-Zenapax

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study title

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

Important dates

First posted
Aug 17, 2011
Registry last updated
Aug 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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