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

Completed · Phase 3

Conditions studied: Lymphoma, Large-Cell, Diffuse

In brief

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.

Key facts

Study ID

NCT00137995

Run by

Lymphoma Study Association

People needed

481

Starts

2003-06-01

Expected to finish

2008-10-01

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Australian leukemia and lymphoma group — Sydney, Australia
• Groupe d'atude des lymphome de l'adulte — Yvoir, Belgium
• Czech Lymphoma study group — Prague, Czechia
• Hospital district of south west Finland — Turku, Finland
• German high grade non hodgkin's lymphoma group — Hamburg, Germany
• Israel Society of Hematology — Tel Litwinsky, Israel
• Nordic center — Uppsala, Sweden
• Schweirische Arbeitsgruppe fur klinische Krebsforschung — Lausanne, Switzerland
• National cancer research institute — London, United Kingdom

Full record on ClinicalTrials.gov

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