OncoMatch/Clinical Trials/NCT06249191
Mosunetuzumab With Chemotherapy for the Treatment of Patients With Untreated C-Myc Rearrangement Positive High Grade B Cell Lymphoma or Diffuse Large B Cell Lymphoma
Is NCT06249191 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments for diffuse large b-cell lymphoma.
Treatment: Cyclophosphamide · Doxorubicin · Etoposide · Mosunetuzumab · Prednisone · Vincristine — This phase Ib/II clinical trial tests the safety, side effects, and effectiveness of mosunetuzumab with chemotherapy for the treatment of patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as mosunetuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as etoposide, doxorubicin, vincristine, cyclophosphamide and prednisone work in different ways to stop the growth of cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving mosunetuzumab with chemotherapy may be safe, tolerable and/or effective in treating patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: MYC rearrangement
documented c-Myc rearrangement on fluorescence in situ hybridization (FISH) testing
Required: MYC single rearrangement (single-hit lymphoma)
any single MYC rearrangement (single-hit lymphoma [SHL])
Required: MYC double rearrangement (double-hit lymphoma, dhl)
Double hit (DHL) lymphoma defined by translocations of MYC and BCL2
Required: MYC triple rearrangement (triple-hit lymphoma, thl)
triple hit (THL) lymphoma defined by translocations of MYC and BCL2 (DHL) and BCL6 (THL)
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: systemic therapy for DLBCL
Exception: Course of bendamustine plus rituximab (BR) > 3 years prior for follicular lymphoma, or any history of rituximab treatment; pre-phase therapy (prednisone ≤ 100 mg for up to 14 days, one cycle of RCHOP, DA R EPOCH, BR, single agent rituximab, radiation to up to 3 disease sites) allowed with washout (3 weeks for chemo/radiation, 4 weeks for mediastinal/pericardial radiation)
Prior treatment for DLBCL. Exceptions: Course of bendamustine plus rituximab (BR) > 3 years prior for follicular lymphoma, or any history of rituximab treatment; pre-phase therapy allowed (prednisone ≤ 100 mg for up to 14 days, one cycle of RCHOP, DA R EPOCH, BR, single agent rituximab, radiation to up to 3 disease sites) with washout
Cannot have received: solid organ transplantation
Prior solid organ transplantation
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.0 ×10^9/L unless inadequate function is due to underlying disease; Platelet count ≥ 75 ×10^9/L unless inadequate function is due to underlying disease
Kidney function
Serum creatinine ≤ ULN; or estimated creatinine clearance ≥ 50 mL/min by Cockcroft Gault method or other institutional standard methods
Liver function
AST or ALT ≤ 2.5 x ULN; total bilirubin < 1.5 x ULN
Cardiac function
Left ventricular ejection fraction (LVEF) within institutional limits of normal
LVEF defined by MUGA scan or ECHO within institutional limits of normal; ANC ≥ 1.0 ×10^9/L; Platelet count ≥ 75 ×10^9/L; Serum creatinine ≤ ULN or CrCl ≥ 50 mL/min; AST or ALT ≤ 2.5 x ULN; total bilirubin < 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- OHSU Knight Cancer Institute · Portland, Oregon
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06249191 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require MYC?
Yes, MYC rearrangement is a required biomarker for enrollment.
Does this trial require MYC?
Yes, MYC single rearrangement (single-hit lymphoma) is a required biomarker for enrollment.
Does this trial require MYC?
Yes, MYC double rearrangement (double-hit lymphoma, dhl) is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III or IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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