Status:
COMPLETED
R-ICE Versus R-DHAP in Patients Aged 18-65 With Relapse Diffuse Large B-cell Lymphoma
Lead Sponsor:
Lymphoma Study Association
Conditions:
Lymphoma, Large-Cell, Diffuse
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 patien...
Detailed Description
In vitro, the addition of rituximab to standard anticancer drugs increases cell lyses even in chemoresistant cell lines. This chemosensitization effect was also demonstrated in vivo by the results of ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
481 Patients enrolled
Trial Details
Trial ID
NCT00137995
Start Date
June 1 2003
End Date
October 1 2008
Last Update
August 28 2019
Active Locations (10)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
2
Australian leukemia and lymphoma group
Sydney, Australia
3
Groupe d'atude des lymphome de l'adulte
Yvoir, Belgium
4
Czech Lymphoma study group
Prague, Czechia