HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL)Phase 4NCT01418430
Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab)
A Phase 4 study testing CHOP-daclizumab in people with HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL), run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL)
- What is being tested?
- CHOP-daclizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed ATLL requiring treatment
- Frank acute leukaemia or lymphoma subtypes
- Chronic and smouldering cases should be considered if they are symptomatic and require therapy, or there is evidence of disease progression
- No previous treatment with anthracycline based cytotoxic chemotherapy
- Patients may have received interferon and /or zidovudine and/or non-anthracycline based therapy
- Age 18-75 years
- Written informed consent
Who cannot join
- HIV 1 or 2 positivity
- Pregnancy or breast-feeding
- Concomitant chemo-radiotherapy
- 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
- Other concomitant neoplasms not related to HTLV-I
- Cardiac or respiratory insufficiency with an ECOG score of greater than 3
- Any serious active uncontrolled infection
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London, SE5 9RS
About this study
Official title: 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.
- Being tested
- CHOP-daclizumab
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOP-daclizumabDrug
Also called CHOP-Zenapax
| Study group | Role | What they receive |
|---|---|---|
| CHOP-daclizumab | Experimental | Not described Receives: Drug: CHOP-daclizumab |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL)Studies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418430
- Sponsor's protocol ID
- CHOP-Z
- Status last verified
- Jul 2011
- First submitted
- 16 Aug 2011
- Last updated
- 22 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL) Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab)
- ClinicalTrials.gov ID
- NCT01418430
- Acronym / sponsor ID
- CHOP-Z
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- First posted
- 17 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHOP-daclizumab | Experimental | Drug: CHOP-daclizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed ATLL requiring treatment
- No previous treatment with anthracycline based cytotoxic chemotherapy
- Age 18-75 years
- Written informed consent
Key exclusion criteria (7 listed)
- HIV 1 or 2 positivity
- Pregnancy or breast-feeding
- Concomitant chemo-radiotherapy
- 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
- Other concomitant neoplasms not related to HTLV-I
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHOP-daclizumabAlso: CHOP-Zenapax | Drug | CHOP-daclizumab |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2011.
Related trials for HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL)
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Acute Adult T-Cell Leukemia/Lymphoma, Adult T-Cell Leukemia/Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CHOP-daclizumab in people with HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL), run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2011.