Clinical trial · Interventional
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)
NCT01418430CI-TRIAL-00005385completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL) | Adult T-Cell Leukemia/Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CHOP-daclizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CHOP-daclizumab
- interventionNames
- Drug: CHOP-daclizumab
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.