Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted stem cell transplantation
| ISRCTN | ISRCTN51398568 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51398568 |
| Protocol serial number | LUMC 2007-01 |
| Sponsor | Leiden University Medical Centre (Netherlands) |
| Funder | Leiden University Medical Centre (Netherlands) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Phase II, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Immune reconstitution at 6 months. |
| Key secondary outcome measure(s) |
1. Chimerism and disease status as measured by minimal residual disease at 6 months |
| Completion date | 01/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
