A pilot study to compare CAMPATH-1H produced from YO or CHO cells in patients with B-cell chronic lymphocytic leukaemias (Protocol CLL-TF57)
| ISRCTN | ISRCTN59778423 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59778423 |
| Secondary identifying numbers | N0123119552 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 14/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Martin Dyer
Scientific
Scientific
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
| Phone | +44 (0)116 258 4109 |
|---|---|
| nicola.turner@uhl-tr.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A pilot study to compare CAMPATH-1H produced from YO or CHO cells in patients with B-cell chronic lymphocytic leukaemias (Protocol CLL-TF57) |
| Study objectives | To determine and compare the rates of lymphocyte clearance with YO-CAMPATH-1H and CHO-CAMPATH-1H in patients with advanced CLL or T-cell prolymphocytic leukemia (T-PLL) who have failed prior chemotherapy to test whether YO-CAMPATH is more potent. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | B-cell chronic lymphocytic leukaemia |
| Intervention | Randomised controlled trial |
| Intervention type | Other |
| Primary outcome measure | Rates of clearance of malignant lymphocytes from peripheral blood with the two antibody preparations to allow direct comparison of the efficacy of both. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/2002 |
| Completion date | 01/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Haematology patients |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/07/2002 |
| Date of final enrolment | 01/07/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
University Hospitals of Leicester NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
14/02/2018: No publications found in PubMed, verifying study status with principal investigator.
