CHOEP-14 + Rituximab With CNS Prophylaxis in Patients Less Than 65 Years With Diffuse Large B-Cell Lymphoma/Follicular Lymphoma Grade III, Stage II-IV With Risk Factors (Age Adjusted IPI) ≥ 2. A Phase II Study
18 Years
64 Years
Both
Diffuse Large B-Cell Lymphoma
Trial Information
CHOEP-14 + Rituximab With CNS Prophylaxis in Patients Less Than 65 Years With Diffuse Large B-Cell Lymphoma/Follicular Lymphoma Grade III, Stage II-IV With Risk Factors (Age Adjusted IPI) ≥ 2. A Phase II Study
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 patients receive CHOEP-14 with rituximab x 6 with the support of G-CSF followed by high
dose cytarabine i.v. and high dose methotrexate i.v.Intrathecal (i.t.) CNS prophylaxis in
combination with chemotherapy is not to be given, but i.t. methotrexate may be given once
after initial liquid sampling. Radiotherapy will be given at the discretion of the
individual centres.
Investigations before, during and after treatment:
The disease status will be assessed prior to treatment start, after 3 cycles of CHOEP +
rituximab and after completion of the treatment schedule. Positron Emission Tomography (PET)
using F18 deoxyglucose may be performed after fulfillment of treatment. Persistent,
suspected lymphoma tissue should whenever possible be confirmed with a biopsy, otherwise the
patient will be regarded as PR and second line therapy will be considered (see schematic
outline).
Clinical and radiological (CT) assessment are performed at pretreatment and subsequently on
sites initially involved, and bone marrow biopsy if initially involved
- After the 3rd course
- After the last course (within one month) of chemotherapy (biopsy if indicated)
- After radiotherapy (for patient given radiotherapy as part of the primary treatment)
Clinical follow-up:
- 4x per year during the first and second year of follow-up
- 2x per year during the third, fourth and fifth year of follow-up
Radiological investigations at follow up:
-CT after 6, 12 and 24 months of sites initially involved. CT abdomen in all cases after 12
and 24 months. X-ray of the thorax (if CT thorax is performed) after 6, 12 and 24 months
Inclusion Criteria:
1. Age ≥ 18 - < 65 years.
2. 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
3. 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.
4. Previously untreated.
5. Performance status < 4 (Appendix 2).
6. Written informed consent
Exclusion Criteria:
1. 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).
2. Impaired liver, renal or other organ function not caused by lymphoma, which will
interfere with the treatment schedule.
3. Pregnancy.
4. 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.
5. Patients with other severe medical problems and with an expected short survival for
non-lymphoma reasons.
6. Known HIV positivity.
7. Present or previous cancer except basal cell carcinoma and cervical carcinoma in
situ.
8. Uncontrolled infectious disease.
9. Psychiatric or mental disorder which make the patient unable to give an informed
consent and/or adhere to the protocol.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to treatment failure
Outcome Description:
Interval between the registration date and the date of documented progression or lack of response, first relapse, death for any reason or discontinuation/change of therapy because of toxicity, whichever occurs first. Otherwise, patients will be censored at the last date they were known to be alive. For patients not responding at any time point on study treatment, TTF is defined as 1 day.
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Harald Holte, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Oslo University Hospital
Authority:
Finland: Finnish Medicines Agency
Study ID:
NLG-LBC-04
NCT ID:
NCT01502982
Start Date:
November 2004
Completion Date:
December 2013
Related Keywords:
- Diffuse Large B-Cell Lymphoma
- DLBCL
- high risk
- young
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
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