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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01418430
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : August 22, 2011
Sponsor:
Information provided by:

August 16, 2011
August 17, 2011
August 22, 2011
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Complete list of historical versions of study NCT01418430 on ClinicalTrials.gov Archive Site
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Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab)
HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL) 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.
Not Provided
Interventional
Phase 4
Primary Purpose: Treatment
HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL)
Drug: CHOP-daclizumab
Other Name: CHOP-Zenapax
Experimental: CHOP-daclizumab
Intervention: Drug: CHOP-daclizumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01418430
CHOP-Z
Yes
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Dr Antonio Pagliuca, King's College Hospital NHS Foundation Trust
King's College Hospital NHS Trust
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King's College Hospital NHS Trust
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP