Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted stem cell transplantation
| ISRCTN | ISRCTN51398568 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51398568 |
| Secondary identifying numbers | LUMC 2007-01 |
- Submission date
- 31/08/2007
- Registration date
- 27/06/2008
- Last edited
- 14/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof J H F Falkenburg
Scientific
Scientific
Leiden University Medical Centre
Albunisdreef 2
Leiden
2333 ZA
Netherlands
| Phone | +31 (0)71 526 2271 |
|---|---|
| J.H.F.Falkenburg@lumc.nl |
Study information
| Study design | Phase II, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Infusion of CD4 positive donor lymphocytes after T-cell depleted stem cell transplantation will increase immune reconstitution. |
| Ethics approval(s) | Central Committee on Research involving Human Subjects, Netherlands (CCMO). Date of approval: 27/05/2008 |
| Health condition(s) or problem(s) studied | Haematological malignancy |
| Intervention | Infusion with CD4 positive donor lymphocytes vs standard care. |
| Intervention type | Other |
| Primary outcome measure | Immune reconstitution at 6 months. |
| Secondary outcome measures | 1. Chimerism and disease status as measured by minimal residual disease at 6 months 2. Incidence of viral infections between 3 and 6 months |
| Overall study start date | 01/07/2008 |
| Completion date | 01/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Both males and females 2. Age from 18 to 70 years 3. Patients with acute myeloid leukaemia (AML), myelodysplasia (MDS), acute lymphocytic leukaemia (ALL), chronic myeloid leukaemia (CML) in accelerated phase or blastic transformation, chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) or aggressive lymphoma, who received an allogeneic stem cell transplantation. |
| Key exclusion criteria | 1. Systemic immunosuppressive treatment 2. Progressive Graft Versus Host Disease (GVHD) 3. GVHD of the skin greater than grade 2 4. Progressive disease needing cytoreductive treatment |
| Date of first enrolment | 01/07/2008 |
| Date of final enrolment | 01/10/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Centre
Leiden
2333 ZA
Netherlands
2333 ZA
Netherlands
Sponsor information
Leiden University Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Albunisdreef 2
Leiden
2333 ZA
Netherlands
| Website | http://www.lumc.nl |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Hospital/treatment centre
Leiden University Medical Centre (Netherlands)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/09/2013 | Yes | No |
