Dose Dense Chemotherapy and Rituximab for Young High Risk Diffuse Large B-Cell Lymphoma Patients (CRY-04)
NCT ID: NCT01502982
Last Updated: 2014-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2004-11-30
2014-05-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chemoimmunotherapy
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
64 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Nordic Lymphoma Group
NETWORK
Responsible Party
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Principal Investigators
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Harald Holte, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Odense University Hospital
Odense, , Denmark
Helsinki University central Hospital
Helsinki, , Finland
Oslo University Hospital
Oslo, , Norway
Lund University Hospital
Lund, , Sweden
Countries
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References
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Autio M, Leivonen SK, Bruck O, Mustjoki S, Meszaros Jorgensen J, Karjalainen-Lindsberg ML, Beiske K, Holte H, Pellinen T, Leppa S. Immune cell constitution in the tumor microenvironment predicts the outcome in diffuse large B-cell lymphoma. Haematologica. 2021 Mar 1;106(3):718-729. doi: 10.3324/haematol.2019.243626.
Taskinen M, Louhimo R, Koivula S, Chen P, Rantanen V, Holte H, Delabie J, Karjalainen-Lindsberg ML, Bjorkholm M, Fluge O, Pedersen LM, Fjorden K, Jerkeman M, Eriksson M, Hautaniemi S, Leppa S. Deregulation of COMMD1 is associated with poor prognosis in diffuse large B-cell lymphoma. PLoS One. 2014 Mar 13;9(3):e91031. doi: 10.1371/journal.pone.0091031. eCollection 2014.
Holte H, Leppa S, Bjorkholm M, Fluge O, Jyrkkio S, Delabie J, Sundstrom C, Karjalainen-Lindsberg ML, Erlanson M, Kolstad A, Fossa A, Ostenstad B, Lofvenberg E, Nordstrom M, Janes R, Pedersen LM, Anderson H, Jerkeman M, Eriksson M. Dose-densified chemoimmunotherapy followed by systemic central nervous system prophylaxis for younger high-risk diffuse large B-cell/follicular grade 3 lymphoma patients: results of a phase II Nordic Lymphoma Group study. Ann Oncol. 2013 May;24(5):1385-92. doi: 10.1093/annonc/mds621. Epub 2012 Dec 17.
Riihijarvi S, Nurmi H, Holte H, Bjorkholm M, Fluge O, Pedersen LM, Rydstrom K, Jerkeman M, Eriksson M, Leppa S. High serum vascular endothelial growth factor level is an adverse prognostic factor for high-risk diffuse large B-cell lymphoma patients treated with dose-dense chemoimmunotherapy. Eur J Haematol. 2012 Nov;89(5):395-402. doi: 10.1111/ejh.12005. Epub 2012 Sep 14.
Related Links
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Nordic Lymphoma Group
Other Identifiers
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2004-003075-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NLG-LBC-04
Identifier Type: -
Identifier Source: org_study_id