Marrow-ablative chemotherapy and autologous stem cell transplantation followed by interferon-alpha maintenance treatment versus interferon-alpha maintenance treatment alone for stage III and IV follicular Non-Hodgkin's lymphoma
| ISRCTN | ISRCTN81939169 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81939169 |
| ClinicalTrials.gov number | NCT00003152 |
| Secondary identifying numbers | EORTC 20963 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 16/04/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Multicentre randomised active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Marrow-ablative chemotherapy and autologous stem cell transplantation followed by interferon-alpha maintenance treatment versus interferon-alpha maintenance treatment alone for stage III and IV follicular Non-Hodgkin's lymphoma |
| Study objectives | Added 07/08/09: Interferon alpha may interfere with the growth of cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells. The aim of this trial is to compare the effectiveness of combination chemotherapy followed by interferon alfa alone versus combination chemotherapy plus radiation therapy and peripheral stem cell transplantation in treating patients who have previously untreated stage III or stage IV follicular non-Hodgkin's lymphoma. As of 07/08/09 this record has been extensively updated. All updates can be found under the relevant field with the above update date. Please also note that the start date of this trial have been changed from 01/01/1999 as this date was automatically generated on registration. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lymphoma (non-Hodgkin's) |
| Intervention | 1. All patients receive induction chemotherapy with cyclophosphamide, vincristine and prednisolone (CVP) repeated every 21 days for eight cycles. 2. Patients who achieve a complete remission or partial remission with a limited bone marrow infiltration will be randomised to one of the two arms of the protocol: 2.1. Arm A: Maintenance treatment with interferon-alpha, 3MU three times weekly until disease progression or relapse (a maximum period of three years). 2.2. Arm B: Patients receive cylophosphamide priming and peripheral blood stem cell harvest followed by marrow-ablative chemo-radiotherapy. Marrow-ablative chemo-radiotherapy consists of high-dose cyclophosphamide and total body irradiation at a total dose of 9 Gy to the midline of the body plus peripheral blood stem cell reinfusion. Maintenance treatment with interferon-alpha, 3MU three times weekly is given until disease progression or relapse (a maximum period of three years). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Cyclophosphamide, vincristine and prednisolone (CVP), interferon-alpha. |
| Primary outcome measure | Added 07/08/09: 1. Progression free and overall survival 2. Toxicity 3. Mortality Patients are followed every 4 months until death. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 28/03/1997 |
| Completion date | 15/11/1999 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 469 patients will be accrued for this study within 5 years (added 07/08/09) |
| Key inclusion criteria | Current information as of 07/08/09: 1. Previously untreated follicular non-Hodgkin's lymphoma presenting with stages III or IV, including nodal, Waldeyers ring and extranodal locations - at least one measurable mass should be present 2. Above 18 years and below 66 years 3. World Health Organisation (WHO) performance status zero to two 4. Alkaline phosphatase and bilirubin less than 2.5 times upper limit of normal (ULN) (unless clearly related to NHL) 5. Creatinine and BUN less than 2.5 times ULN (unless clearly related to NHL) Initial information at registration: 1. Previously untreated follicular non-Hodgkin's lymphoma presenting with stages III or IV, including nodal, Waldeyers ring and extranodal locations - at least one measurable mass should be present 2. Above 18 years and below 66 years 3. World Health Organisation (WHO) performance status zero to two |
| Key exclusion criteria | Current information as of 07/08/09: 1. Prior malignancies except non-melanoma skin tumours or stage 0 in situ cervical carcinoma 2. Severe cardiac disease (e.g. severe heart failure requiring treatment or cardiac ejection fraction less than 45%) 3. Neurologic disease 4. Pulmonary disease 5. Psychiatric or metabolic disease 6. HIV positive 7. Pregnancy 8. Other medical contraindications to protocol treatments Initial information at registration 1. Prior malignancies except non-melanoma skin tumours or stage 0 in situ cervical carcinoma 2. Other medical contraindications to protocol treatments |
| Date of first enrolment | 28/03/1997 |
| Date of final enrolment | 15/11/1999 |
Locations
Countries of recruitment
- England
- Netherlands
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Research organisation
Research organisation
83, Avenue E. Mounier
Bte 11
Brussels
B-1200
Belgium
| Phone | +32 2 774 16 41 |
|---|---|
| eortc@eortc.be | |
| Website | http://www.eortc.be |
"ROR" |
https://ror.org/034wxcc35 |
Funders
Funder type
Research organisation
Added 07/08/09:
No information available
European Organization for Research and Treatment of Cancer (EORTC) (ref: 20963)
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 | 01/01/1998 | 16/04/2019 | Yes | No |
Editorial Notes
16/04/2019: The trial was stopped as only 30 patients were randomised in two and a half years.
