A randomised trial of high dose therapy and autologous bone marrow transplantation versus continuing conventional combination chemotherapy for adults with lymphoblastic lymphoma
| ISRCTN | ISRCTN58831878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58831878 |
| Protocol serial number | LY01 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 28/11/2019
- 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
Mr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised trial of high dose therapy and autologous bone marrow transplantation versus continuing conventional combination chemotherapy for adults with lymphoblastic lymphoma |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lymphoma (non-Hodgkin's) cancer |
| Intervention | All patients receive induction therapy and conventional chemotherapy regimens. Patients achieving complete remission or partial remission are randomised to either: 1. Regimen A: Continue therapy on conventional regimen. The recommended conventional regimen is modified LSA2L2. 2. Regimen B: High dose therapy and ABMT. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 119 |
| Total final enrolment | 119 |
| Key inclusion criteria | 1. Histologically documented lymphoblastic lymphoma 2. No prior chemotherapy or radiotherapy, except chemotherapy given for immediate relief of symptoms at presentation 3. Age 15 or over 4. All stages 5. No circulating blasts 6. Normal values for renal and hepatic function, unless directly attributable to lymphoma 7. Normal cardiac function 8. No evidence of Human Immunodeficiency Virus (HIV) infection |
| Key exclusion criteria | Patients will be excluded if they have HLA-identical siblings who are undergoing allogenic bone marrow transplantation. These patients should be registered with the trials office but will not be randomised. |
| Date of first enrolment | 01/01/1992 |
| Date of final enrolment | 30/04/1997 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2001 | 28/11/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
