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

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
CHOP-daclizumab
Sponsored by
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King's College Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CHOP-daclizumab

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 16, 2011
Last Updated
August 19, 2011
Sponsor
King's College Hospital NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01418430
Brief Title
Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab)
Official Title
HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL) Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
King's College Hospital NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4

8. Arms, Groups, and Interventions

Arm Title
CHOP-daclizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CHOP-daclizumab
Other Intervention Name(s)
CHOP-Zenapax

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

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

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