A Phase 2 interventional study of R-CHOEP14x6+HD-AraC+HD-Mtx in Diffuse Large B-Cell Lymphoma, sponsored by Nordic Lymphoma Group. Completed at 4 sites in 4 countries. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2014-09-30.
Sponsored by Nordic Lymphoma Group · Phase 2, Interventional, and Treatment
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 could improve time to treatment failure and reduce the risk of CNS relapses. Six courses of rituximab-cyclophosphamide-doxorubicin-etoposide-vincristine-prednison (R-CHOEP) given in two weeks intervals with the support of G-CSF is followed by one course of high dose methotrexate (HD-MTX) and high dose cytarabine (HD-Ara-C). The results will be compared to a historical Nordic 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
Clinical 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
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 160 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Histology verified according to the WHO classification and with CD20 positivity by immunhistochemistry or flow cytometry:
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.
Exclusion Criteria:
Drug: R-CHOEP14x6+HD-AraC+HD-Mtx
rituximab 375 mg/m2 day 1 cyclophosphamide 750 mg/m2 day 1 doxorubicin 50 mg/m2 day 1 vincristine 1.4 mg/m2 day 1 etoposide 100mg/m2 days 1,2,3 Prednison 100 mg days 1,2,3,4,5 cycle repeated six times every two weeks followed by HD-AraC 3g/m2x4 and HD-mtx 3 g/m2 HD-AraC 3g/m2x4 times every 12 h
Also known as: R-CHOEP14x6, HD-MTXx1, HD-AraCx1
Time to treatment failure
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.
Time frame: 5 years
Number of participants with adverse events
Grade 2-4 hematological and non-hematological adverse events according to the WHO Common Toxicity Criteria as specified in the protocol
Time frame: Treatment period (5 years)
Clinical response rate
Number of patients with complete and partial responses, stable or progressive disease after 3 courses and the end of treatment period
Time frame: Treatment period (5 years)
Time to progression
Time from registration to the date of disease progression. Otherwise, the patients are censored at the last date of follow up. Patients still alive in a complete response or lost to follow-up are censored at the last date they were known to be alive. Patients who die due to causes other than lymphoma are censored at the date of death
Time frame: 5 years
Overall survival
Time from the registration date to the date of death. Patients still alive or lost to follow-up are censored at the last date they were known to be alive.
Time frame: 5 years
Incidence of CNS relapse
Time frame: Treatment period (5 years)
Molecular factors important for clinical outcome
Time frame: Treatment period (5 years)
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Nordic Lymphoma Group