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

Sponsor
King's College Hospital NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT01418430
Collaborator
(none)
1
Location
1
Arm

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL) Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab)

Arms and Interventions

Arm Intervention/Treatment
Experimental: CHOP-daclizumab

Drug: CHOP-daclizumab
Other Names:
  • CHOP-Zenapax

    		•

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 75 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      1. Histologically confirmed ATLL requiring treatment

      2. Frank acute leukaemia or lymphoma subtypes

      3. Chronic and smouldering cases should be considered if they are symptomatic and require therapy, or there is evidence of disease progression

      4. No previous treatment with anthracycline based cytotoxic chemotherapy

      1. Patients may have received interferon and /or zidovudine and/or non-anthracycline based therapy

      1. Age 18-75 years

      2. 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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 King's College Hospital NHS Foundation Trust London United Kingdom SE5 9RS

      Sponsors and Collaborators

      • King's College Hospital NHS Trust

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01418430
      Other Study ID Numbers:
      • CHOP-Z
      First Posted:
      Aug 17, 2011
      Last Update Posted:
      Aug 22, 2011
      Last Verified:
      Jul 1, 2011
      Additional relevant MeSH terms:
      Lymphoma
      Leukemia
      Leukemia, T-Cell
      Leukemia-Lymphoma, Adult T-Cell
      Daclizumab

      Study Results

      No Results Posted as of Aug 22, 2011