OncoMatch/Clinical Trials/NCT05861050
Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma
Is NCT05861050 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Glofitamab and Obinutuzumab for blastoid variant mantle cell lymphoma.
Treatment: Glofitamab · Lenalidomide · Obinutuzumab · Venetoclax — This phase I/II trial tests the safety and effectiveness of glofitamab (with obinutuzumab pretreatment), venetoclax, and lenalidomide in treating patients with newly diagnosed, high risk mantle cell lymphoma. Glofitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Lenalidomide works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Giving venetoclax, glofitamab with obinutuzumab, and lenalidomide together may kill more cancer cells in patients with newly diagnosed, high risk mantle cell lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CCND1 t(11;14) translocation
Evidence of t(11;14) translocation involving the cyclin D1 gene by fluorescence in situ hybridization (FISH)
Required: CCND1 overexpression
cyclin D1 expression by immunohistochemistry (IHC)
Required: SOX11 overexpression
IHC expression of SOX11
Allowed: TP53 mutation
Presence of a TP53 mutation defined by either molecular testing or IHC
Allowed: CDKN2A deletion
del (17p) by FISH
Allowed: KMT2D mutation
The presence of other high risk gene mutations (KMT2D, NSD2, NOTCH1, CDKN2A, NOTCH2, SMARCA4, CCND1) as long one of the other features above are present
Allowed: NSD2 mutation
The presence of other high risk gene mutations (KMT2D, NSD2, NOTCH1, CDKN2A, NOTCH2, SMARCA4, CCND1) as long one of the other features above are present
Allowed: NOTCH1 mutation
The presence of other high risk gene mutations (KMT2D, NSD2, NOTCH1, CDKN2A, NOTCH2, SMARCA4, CCND1) as long one of the other features above are present
Allowed: CDKN2A mutation
The presence of other high risk gene mutations (KMT2D, NSD2, NOTCH1, CDKN2A, NOTCH2, SMARCA4, CCND1) as long one of the other features above are present
Allowed: NOTCH2 mutation
The presence of other high risk gene mutations (KMT2D, NSD2, NOTCH1, CDKN2A, NOTCH2, SMARCA4, CCND1) as long one of the other features above are present
Allowed: SMARCA4 mutation
The presence of other high risk gene mutations (KMT2D, NSD2, NOTCH1, CDKN2A, NOTCH2, SMARCA4, CCND1) as long one of the other features above are present
Allowed: CCND1 mutation
The presence of other high risk gene mutations (KMT2D, NSD2, NOTCH1, CDKN2A, NOTCH2, SMARCA4, CCND1) as long one of the other features above are present
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
Without bone marrow involvement: ANC >= 1,000/mm^3, Platelets >= 75,000/mm^3, Hemoglobin >= 8 g/dL; With bone marrow involvement: ANC >= 500/mm^3, Platelets >= 25,000/mm^3, Hemoglobin >= 7 g/dL
Kidney function
Creatinine clearance of >= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Liver function
Total bilirubin <= 1.5 x ULN (unless has Gilbert's disease); AST <= 3.0 x ULN; ALT <= 3.0 x ULN
Without bone marrow involvement: ANC >= 1,000/mm^3; Platelets >= 75,000/mm^3; Hemoglobin >= 8 g/dL. With bone marrow involvement: ANC >= 500/mm^3; Platelets >= 25,000/mm^3; Hemoglobin >= 7 g/dL. Total bilirubin <= 1.5 x ULN (unless has Gilbert's disease); AST <= 3.0 x ULN; ALT <= 3.0 x ULN. Creatinine clearance of >= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
- Huntsman Cancer Institute · Salt Lake City, Utah
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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