R-ICE Versus R-DHAP in Patients Aged 18-65 With Relapse Diffuse Large B-cell Lymphoma

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the efficacy and safety of induction therapy R-ICE in comparison to R-DHAP after 3 cycles adjusted to successful mobilization of stem cells in patients with previously treated diffuse large B-cell lymphoma CD20.

The goal is to detect a difference in mobilization adjusted response rate of 15% between R-ICE and R-DHAP.

The other objective is to evaluate the efficacy and safety of MabThera maintenance therapy after transplantation as measured by the event free survival.

The goal is to obtain a 15% increase of event free survival at 2 years.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lymphoma Study Association
• Treatments: BB 1101; Carboplatin; Cytarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Melphalan; Mesna; Rituximab

Criteria

Inclusion Criteria:

• Patients with CD20-positive diffuse large B-cell lymphoma. Disease must be histologically proven in case of relapse or partial response.

• Aged 18 to 65 years

• First relapse after complete remission (CR), less than partial remission (PR) or partial response to first line treatment not achieving documented or confirmed complete remission.

• Eligible for transplant

• Previously treated with chemotherapy regimen containing anthracyclines with or without rituximab.

• ECOG performance status 0 to 2.

• Minimum life expectancy of 3 months.

• Signed written informed consent prior to randomization.

Exclusion Criteria:

• Burkitt, mantle-cell and T-cell lymphoma.

• CD20-negative diffuse large cell lymphoma

• Documented infection with HIV and hepatitis B virus [HBV] (in the absence of vaccination)

• Central nervous system or meningeal involvement by lymphoma.

• Not previously treated with anthracycline-containing regimens

• Prior transplantation

• Contra-indication to any drug contained in the chemotherapy regimens.

• Any serious active disease or co-morbid condition (according to the investigator's decision and information provided in the Investigational Drug Brochure [IDB]).

• Poor renal function (creatinine level > 150µmol/l or 1.5-2.0 x upper limit of normal [ULN]); poor hepatic function (total bilirubin level > 30mmol/l [> 1.5 x ULN], transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma; poor bone marrow reserve as defined by neutrophils < 1.5G/l or platelets < 100G/l, unless related to bone marrow infiltration.

• Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.

• Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.

• Pregnant women

• Adult patients unable to provide informed consent because of intellectual impairment.