Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00005589
• Date of registration: 02/05/2000
• Primary sponsor: EBMT Solid Tumors Working Party
• Public title: Combination Chemotherapy Plus Peripheral Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
• Scientific title: Randomized Study of Rituximab (Mabthera) in Patients With Relapsed Follicular Lymphoma Prior to High-Dose Therapy as In Vivo Purging and to Maintain Remission Following High-Dose Therapy
• Date of first enrolment: October 1999
• Target sample size: 460
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00005589
• Study type: Interventional
• Study design: Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Israel, New Zealand, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom

Contacts

• Name: David C. Linch
• Affiliation: Middlesex Hospital

• Name: Ruth Pettengell, MD
• Affiliation: St George's, University of London

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Relapsed or resistant follicular non-Hodgkin's lymphoma (NHL)

- No evidence of transformation to high grade or diffuse large B-cell NHL

- CD20 positive with no evidence of transformation

- Achievement of complete remission (CR) or very good partial remission (VGPR)
following reinduction chemotherapy with any standard regimen

- Includes patients who fail to respond to first-line chemotherapy but who achieve
CR or VGPR after proceeding directly to second-line chemotherapy

- Platelet count greater than 100,000/mm^3 after induction chemotherapy and before
randomization

- No CNS involvement

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- WHO 0-1

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

Hepatic:

- Bilirubin normal

- ALT no greater than 2 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2 times ULN

- Hepatitis B negative

- Hepatitis C negative

Renal:

- Creatinine no greater than 2 times ULN

- BUN no greater than 2 times ULN

Cardiovascular:

- No inadequate cardiac function

Pulmonary:

- No inadequate pulmonary function

Other:

- Not pregnant or nursing

- HIV negative

- No other uncontrolled serious medical conditions

- No other malignancy within the past 5 years except nonmelanoma skin tumors or
carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- More than 12 months since prior CD20 therapy, including rituximab

- No prior peripheral blood stem cell transplantation

Chemotherapy:

- See Disease Characteristics

- No more than 3 prior chemotherapy regimens for NHL

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy to greater than 30% of bone marrow

Surgery:

- Not specified



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphoma

Intervention(s)

Biological: filgrastim

Biological: rituximab

Drug: carmustine

Drug: cyclophosphamide

Drug: cytarabine

Drug: etoposide

Drug: melphalan

Procedure: bone marrow ablation with stem cell support

Procedure: peripheral blood stem cell transplantation

Primary Outcome(s)

Time to disease progression [Time Frame: No]

Secondary Outcome(s)

Molecular remission rates [Time Frame: No]

Response rate and survival [Time Frame: No]

Safety [Time Frame: Yes]

Secondary ID(s)

BNLI-EBMT-EBMTLYM1

CDR0000067665

EBMT-EBMTLYM1

EU-99050

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Lymphoma Trials Office