OncoMatch/Clinical Trials/NCT02858258
ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma
Is NCT02858258 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including R-CHOP/R-DHAP and Ibrutinib (Induction) for mantle cell lymphoma.
Treatment: R-CHOP/R-DHAP · Ibrutinib (Induction) · ASCT conditioning · Ibrutinib (Maintenance) — The primary objective of the the trial is to establish one of three study arms, as future standard based on the comparison of the investigator-assessed failure-free survival.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Disease stage
Required: Stage II, III, IV
Performance status
ECOG/WHO 0–2
Prior therapy
Cannot have received: radiation therapy
Exception: prephase therapy according to trial protocol
Previous lymphoma therapy with radiation, cytostatic drugs, anti-CD20 antibody or interferon except prephase therapy according to trial protocol
Cannot have received: cytotoxic chemotherapy
Exception: prephase therapy according to trial protocol
Previous lymphoma therapy with radiation, cytostatic drugs, anti-CD20 antibody or interferon except prephase therapy according to trial protocol
Cannot have received: anti-CD20 antibody
Exception: prephase therapy according to trial protocol
Previous lymphoma therapy with radiation, cytostatic drugs, anti-CD20 antibody or interferon except prephase therapy according to trial protocol
Cannot have received: interferon
Exception: prephase therapy according to trial protocol
Previous lymphoma therapy with radiation, cytostatic drugs, anti-CD20 antibody or interferon except prephase therapy according to trial protocol
Cannot have received: organ, bone marrow or peripheral blood stem cell transplantation
Prior organ, bone marrow or peripheral blood stem cell transplantation
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1000 cells/µL; Platelets ≥100,000 cells/µL
Kidney function
Creatinine ≤2 mg/dL or calculated creatinine clearance ≥ 50 mL/min
Liver function
Transaminases (AST and ALT) ≤3 x upper limit of normal (ULN); Total bilirubin ≤2 x ULN unless due to known Morbus Meulengracht [Gilbert-Meulengracht-Syndrome]
Cardiac function
No clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification or LVEF below LLN
The following laboratory values at screening (unless related to MCL): Absolute neutrophil count (ANC) ≥1000 cells/µL; Platelets ≥100,000 cells/µL; Transaminases (AST and ALT) ≤3 x upper limit of normal (ULN); Total bilirubin ≤2 x ULN unless due to known Morbus Meulengracht [Gilbert-Meulengracht-Syndrome]); Creatinine ≤2 mg/dL or calculated creatinine clearance ≥ 50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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