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

This study has been completed.
Sponsor:
Information provided by:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT01418430
First received: August 16, 2011
Last updated: August 19, 2011
Last verified: July 2011
  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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 16, 2011
Last Updated: August 19, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on October 20, 2014