Main info

Identifier:

HOVON 45 MCL

Sponsor:

HOVON

Included patients:

88

Active sites:

16

(of 17)

Title:

High dose chemotherapy with cytoreduction and in vivo purging of the peripheral stem cell transplant by anti-CD20 (MabThera) in the treatment of mantle cell lymphoma.

Timeline

Flow

Details

Phase:

Prospective Phase II study

Monitoring Type:

Not any more

Objectives:

Eligibility

Inclusion Criteria:

• Patients with histologically and immunologically proven mantle cell lymphoma (CD19+, CD5+, CD23-, Ig-light chain monoclonal, Cyclin-D1protein+)
• Ann Arbor stage II - IV
• CD20 positive
• Age 18-65 years inclusive
• WHO performance status 0 - 2
• Written informed consent

Exclusion Criteria:

• Prior treatment
• Severe organ dysfunction not due to the lymphoma
• Bilirubin > 2.5 x normal
• Creatinine > 150 ��mol/l (not due to lymphoma)
• History of active cancer during the past 5 years, except basal carcinoma of the skin or carcinoma in situ of the cervix
• Uncontrolled infection
• Central nervous system involvement of lymphoma
• Pregnancy
• HIV positivity

Participating Sites

= Active hospitals

= Inactive hospitals