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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418430
• Other study ID #: CHOP-Z
• Status: Completed
• Phase: Phase 4
• First received: August 16, 2011
• Last updated: August 19, 2011

Study information

• Verified date: July 2011
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• CHOP-daclizumab

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom,