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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01418430
First Posted: August 17, 2011
Last Update Posted: August 22, 2011
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.
Information provided by:
King's College Hospital NHS Trust
  Purpose
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 Intervention Phase
HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL) Drug: CHOP-daclizumab Phase 4

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

Resource links provided by NLM:


Further study details as provided by King's College Hospital NHS Trust:

Arms Assigned Interventions
Experimental: CHOP-daclizumab Drug: CHOP-daclizumab
Other Name: CHOP-Zenapax

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418430


Locations
United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College Hospital NHS Trust
  More Information

Responsible Party: Dr Antonio Pagliuca, King's College Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01418430     History of Changes
Other Study ID Numbers: CHOP-Z
First Submitted: August 16, 2011
First Posted: August 17, 2011
Last Update Posted: August 22, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Lymphoma
Leukemia
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Daclizumab
Immunoglobulin G
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs