Status:
UNKNOWN
Zevalin and BEAM High-dose Chemotherapy Compared With BEAM Alone as Conditioning Regimen in Patients With Chemosensitive Relapse of Non-Hodgkin's Lymphoma
Lead Sponsor:
Soroka University Medical Center
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
High-dose chemotherapy and autologous stem-cell transplantation have an established role in the treatment of aggressive Non-Hodgkin's lymphoma (NHL) when refractory to first line chemotherapy or after...
Eligibility Criteria
Inclusion
- Patients with CD20 positive aggressive non-Hodgkin's lymphoma, either diffuse large B-cell or transformed follicular lymphoma as confirmed by a pathological biopsy report.
- Patients who are candidates for stem-cell transplantation due to refractory disease to first line chemotherapy or relapsing disease and comply with standard transplant eligibility criteria.
- Patients must have chemo-sensitive disease achieving at least partial response to salvage chemotherapy.
- Patients were given up to 2 lines of therapy, initial treatment and one salvage treatment. Local radiation therapy for consolidation is not considered a line of therapy.
- Age less than physiologic 65 years.
- Patients with an adequate autologous stem cell collection for transplantation (\>2.5 x 106 CD34+ cells/kg). Backup collection is preferable but not obligatory.
- Patients must sign written informed consent.
- Adequate birth control in fertile patients.
- All prior chemotherapy completed at least three weeks before study treatment
Exclusion
- Chemo-refractory disease or more than 2 prior therapies
- Bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit
- Creatinine \> 2.0 mg/dl
- ECOG-Performance status \< 2
- Uncontrolled infection
- Pregnancy or lactation
- Abnormal lung diffusion capacity (DLCO \< 40% predicted)
- Severe cardiovascular disease
- Chemo-refractory disease as determined by less than partial response to salvage chemotherapy.
- active CNS disease involvement
- Pleural effusion or ascites \> 1 liter
- Known hypersensitivity to rituximab
- Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00463463
Start Date
April 1 2007
Last Update
July 12 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Soroka Universuty Medical Center
Beersheba, Israel, 84101