EUCTR2015-002846-30-SE
Active, not recruiting
Phase 1
BIO-CHIC-Study BIOmarker driven and dose intensified CHemoImmunotherapy with early CNS prophylaxis in patients less than 65 years with high risk diffuse large B-cell lymphoma - BIO-CHIC
HUS-The Hospital District of Helsinki and Uusimaa0 sites120 target enrollmentMay 18, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- HUS-The Hospital District of Helsinki and Uusimaa
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ? 18 \- \< 65 years
- •Histologically confirmed CD20\+ DLBCL based on revised WHO 2008 Lymphoma Classification \[47]. The following subgroups and variants can
- •be included:
- •oALK\-positive large B\-cell lymphoma
- •oIntravascular large B\-cell lymphoma
- •oT\-cell rich B\-cell lymphoma
- •oMyc/BCL\-2 double hit lymphoma
- •oFollicular lymphomas grade 3b
- •oDLBCL with previously undiagnosed concurrent small cell infiltration in bone marrow, lymph node, or extranodal site and lymphomas
- •intermediate between DLBCL and Burkitt’s lymphoma are allowed
Exclusion Criteria
- •Posttransplantation lymphoma (PTLD), discordant or transformed lymphoma
- •Severe cardiac disease: cardiac function grade 3\-4, left ventricular ejection fraction \<45%
- •?Impaired bone marrow liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment Schedule
- •(Hemoglobin \< 9 g/dL, ANC \< 1\.5 × 109/L, Platelet count \< 75 × 109/L, creatinine clearance \< 40 mL/min, ALT/AST \> 2\.5 x ULN, Bilirubin
- •? 1\.5 x ULN, INR \> 1\.5\)
- •Pregnancy/lactation
- •Men and women of reproductive potential not agreeing to use effective contraception during treatment and for 18 months after
- •completion of treatment (Effective contraception is combined (estrogen and progestogen containing) hormonal contraception associated
- •with inhibition of ovulation (oral, intravaginal or transdermal), progestogen\-only hormonal contraception associated with inhibition of
- •ovulation (oral, injectable or implantable), intrauterine device (IUD), ihormone\-releasing IUD, bilateral tubal occlusion, vasectomised
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Biomarker driven treatment for patients less than 65 years with aggressive B-cell lymphomaDiffuse large B-cell lymphomaMedDRA version: 21.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2015-002846-30-DKHUS-The Hospital District of Helsinki and Uusimaa120
Not yet recruiting
Not Applicable
Biomarker study for postoperative AKI of Emergency surgeryAcute abdomenJPRN-UMIN000037653St marianna University School of Medicine150
Active, not recruiting
Phase 1
Biomarker driven treatment for patients less than 65 years with aggressive B-cell lymphomaEUCTR2015-002846-30-FIHUS-The Hospital District of Helsinki and Uusimaa120
Completed
Not Applicable
Biomarker study; study to identify biomarkers for protein intake, a randomized, fully controlled feeding studyGeen aandoeningenUitscheiding van biomerkers na het eten van eiwit in het gezond menselijk lichaamBiomarkers of protein intakeNL-OMON36525Wageningen Universiteit25
Recruiting
Not Applicable
Study of biomarker profiling to unravel the intertwined pathophysiology of coronary artery disease and abdominal aortic aneurysmAbdominal aortic aneurysm10002363NL-OMON53081Erasmus MC, Universitair Medisch Centrum Rotterdam440