Status:
COMPLETED
Dose Dense Chemotherapy and Rituximab for Young High Risk Diffuse Large B-Cell Lymphoma Patients (CRY-04)
Lead Sponsor:
Nordic Lymphoma Group
Collaborating Sponsors:
Amgen
Conditions:
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
The purpose is to test whether dose densified chemoimmunotherapy followed by central nervous system (CNS) prophylaxis for young high risk diffuse large B-cell lymphoma (DLBCL) patients is feasible and...
Detailed Description
Pathology: Patients may be included on the bases of the histological diagnosis of the local pathologist. The specimen will be reviewed by a central pathologist in each country Treatment: All patien...
Eligibility Criteria
Inclusion
- Age ≥ 18 - \< 65 years.
- Histology verified according to the WHO classification and with CD20 positivity by immunhistochemistry or flow cytometry:
- Diffuse large B-cell lymphomas with subgroups except posttransplantation-, Burkitt-like- and primary CNS lymphomas and cases with leptomeningeal lymphoma involvement. Morphologically discordant lymphomas (most often follicular lymphoma and diffuse large cell B-cell lymphoma in different biopsy specimens, e.g. lymphatic gland and bone marrow) and transformed lymphomas are not to be included.
- Follicular lymphomas grade III The diagnosis made by the local pathologist of the participating centre will be accepted for registration
- Patients in at least stage II with age adjusted IPI score of 2 or 3:
- Stage III /IV and elevated LDH and/or WHO performance status 2 - 3 Stage II and elevated LDH and WHO performance status 2 - 3.
- Previously untreated.
- Performance status \< 4 (Appendix 2).
- Written informed consent
Exclusion
- Severe cardiac disease: cardiac function grade 3-4 (Appendix 2) or Left Ventricular Ejection Fraction (LVEF) \< 45% (based on MUGA scintigraphy or echo Doppler cardiography).
- Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
- Pregnancy.
- Men and women of reproductive potential not agreeing to use an acceptable method of birth control during treatment and for six months after completion of treatment.
- Patients with other severe medical problems and with an expected short survival for non-lymphoma reasons.
- Known HIV positivity.
- Present or previous cancer except basal cell carcinoma and cervical carcinoma in situ.
- Uncontrolled infectious disease.
- Psychiatric or mental disorder which make the patient unable to give an informed consent and/or adhere to the protocol.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01502982
Start Date
November 1 2004
End Date
May 1 2014
Last Update
September 30 2014
Active Locations (4)
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1
Odense University Hospital
Odense, Denmark
2
Helsinki University central Hospital
Helsinki, Finland
3
Oslo University Hospital
Oslo, Norway
4
Lund University Hospital
Lund, Sweden