NL-OMON53047RecruitingPhase 3
Phase III study comparing R-CODOX-M/R-IVAC versus dose-adjusted EPOCH-R (DA-EPOCH-R) for patients with newly diagnosed high risk Burkitt lymphoma - HOVON 127 BL / SAKK 37/16
HOVO0 sites90 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •- First diagnosis of high risk Burkitt lymphoma (sporadic and HIV associated),
- •histologically confirmed according to the WHO classification 2008; Upon its
- •availability the WHO 2016 classification should be used, to replace the WHO
- •2008 classification.
- •- High risk disease; i.e. any of following: elevated LDH, WHO performance
- •status >= 2, Ann Arbor stage III or IV (Appendix A), tumour mass >= 10 cm;
- •- Age 18-75 years inclusive;
- •- WHO performance status (PS) 0-3, WHO PS 4 only if disease related;
- •- Written informed consent.
Exclusion Criteria
- •- All histopathological diagnoses other than Burkitt lymphoma according to the
- •WHO classification 2008, irrespective of the presence of a MYC rearrangement;
- •Upon its availability the WHO 2016 classification should be used, to replace
- •the WHO 2008 classification
- •- Patients with endemic Burkitt lymphoma;
- •- Patients with low risk Burkitt lymphoma (i.e. all of following: normal LDH,
- •WHO performance status 0 or 1, Ann Arbor stage I or II, no tumour mass >= 10
- •- Patients with CNS localization of Burkitt lymphoma;
- •- Prior treatment other than local radiation (max. 10 Gy) or short course (max
- •7 days) of steroids <= 1 mg/kg for acute symptoms; or <= 100 mg prednisolone
- •(whichever is greater; or equivalent corticosteroid), or 1 cycle of R-CHOP
- •- Creatinine clearance < 50 ml/min unless lymphoma related;
- •- Inadequate hepatic function: bilirubin > 2.5 * ULN (total) except patients
- •with Gilbert*s syndrome as defined by > 80% unconjugated;
- •- Inadequate heamatological function ANC < 1x109/l and platelets < 75x109 /l
- •unless lymphoma related;
- •- Severe pulmonary dysfunction (CTCAE grade 3-4, see appendix D);
- •- Severe neurological or psychiatric disease;
- •- Active symptomatic ischemic heart disease, myocardial infarction, or
- •congestive heart failure within the past year. If an ultrasound or MUGA scan is
- •obtained the LVEF should exceed 45%;
- •- All men and all women of child-bearing potential not willing or able to use
- •an acceptable method of birth control for the duration of the study and one
- •year beyond treatment completion;
- •- Female subject pregnant or breast-feeding;
- •- History of a prior invasive malignancy in the past 5 years with the exception
- •of basal carcinoma of the skin or stage 0 cervical carcinoma;
- •- Serious concomitant medical illnesses that would jeopardize the patient's
- •ability to receive the regimen with reasonable safety, including active
- •hepatitis B (HBV, see also paragraph 9.3) or hepatitis C (HCV) infection;
- •- Current participation in another clinical trial if interfering with HO127;
- •- Any psychological, familial, sociological and geographical condition
- •potentially hampering compliance with the study protocol and follow-up
Investigators
Similar Trials
Active, not recruiting
Phase 1
Phase III study comparing R-CODOX-M/R-IVAC versus dose-adjusted EPOCH-R (DA-EPOCH-R) for patients with newly diagnosed high risk Burkitt lymphomaEUCTR2013-004394-27-BEHOVON Foundation260
Active, not recruiting
Phase 1
A clinical study comparing two different chemotherapy options for patients with newly diagnosed Burkitt lymphomaHigh-risk Burkitt lymphomaMedDRA version: 20.0Level: LLTClassification code 10006605Term: Burkitt's tumor or lymphomaSystem Organ Class: 100000004864EUCTR2013-004394-27-GBHOVON Foundation260
Active, not recruiting
Phase 1
Phase III study comparing R-CODOX-M/R-IVAC versus dose-adjusted EPOCH-R (DA-EPOCH-R) for patients with newly diagnosed high risk Burkitt lymphomaHigh risk Burkitt LymphomaMedDRA version: 20.0 Level: LLT Classification code 10006605 Term: Burkitt's tumor or lymphoma System Organ Class: 100000004864EUCTR2013-004394-27-NLHOVON Foundation260
Recruiting
Not Applicable
Phase III study comparing R-CODOX-M/R-IVAC versus dose-adjusted EPOCH-R (DA-EPOCH-R) for patients with newly diagnosed high risk Burkitt lymphomaon-hodgkin lymphoma, Burkitt lymphomaBurkitt lymfoomNL-OMON28081Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC Cancer Institute, Clinical Trial CenterP.O. Box 20403000 CA RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl260
Completed
Phase 2
Phase II study of R-CODOX-M/R-IVAC therapy for the patients with newly diagnosed primary mediastinal large B-cell lymphomaPrimary mediastinal large B-cell lymphomaJPRN-UMIN000003793ational Cancer Center Hospital35