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

Phase 3

• Conditions: ymphoma (non-Hodgkin's); Cancer; Other and unspecified types of non-Hodgkin's lymphoma

• Registration Number: ISRCTN81939169
• Lead Sponsor: European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)

Brief Summary

1998 results in: https://www.ncbi.nlm.nih.gov/pubmed/9440721 (added 16/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 1999-11-15
• Study Start: 2002-08-19
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 469

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Added 07/08/09:<br> 1. Progression free and overall survival<br> 2. Toxicity<br> 3. Mortality<br> Patients are followed every 4 months until death.<br>

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration