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

NCT ID: NCT01418430

Last Updated: 2011-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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CHOP-daclizumab

Group Type EXPERIMENTAL

CHOP-daclizumab

Intervention Type DRUG

Interventions

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CHOP-daclizumab

Intervention Type DRUG

Other Intervention Names

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CHOP-Zenapax

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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King's College Hospital NHS Foundation Trust

Locations

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King's College Hospital NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CHOP-Z

Identifier Type: -

Identifier Source: org_study_id

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