主要目的：确定SepB治疗c-Myc重排的复发性/难治性HGBCL的安全性和耐受性以及推荐II期剂量（RP2D）。次要目的：通过客观缓解率（ORR）、缓解持续时间（DoR）、临床获益率、总生存期和无进展生存期评价SepB的临床活性。探索性目的： 1、确定SepB的暴露量及其与临床结局的相关性。 2、评估生物标记物与SepB治疗后疗效之间的相关性。 3、评估细胞遗传学数据与SepB治疗后疗效之间的相关性。

开始日期-

申办/合作机构

北京智康博药肿瘤医学研究有限公司

[+2]

NCT06249191 / Recruiting临床1/2期IIT

A Phase Ib/II Study Evaluating the Safety and Efficacy of Mosunetuzumab in Combination With DA EPOCH in Previously Untreated C-Myc Rearrangement Positive High-Grade B Cell Lymphomas

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.

开始日期2024-06-13

申办/合作机构

OHSU Knight Cancer Institute

[+2]

NCT05263583 / Recruiting临床2期

A Phase 2, Multicenter, Open Label Dose-ranging Study of Sepantronium Bromide in Patients With Relapsed/Refractory c-Myc Rearranged High-grade B-cell Lymphoma (HGBCL)

This is a multi-center Phase 2 study to determine the safety and efficacy of sepantronium bromide (SepB) in adult patients with relapsed or refractory high-grade B-cell lymphoma

开始日期2022-12-09

申办/合作机构-

100 项与 C-Myc重排B细胞淋巴瘤相关的临床结果

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100 项与 C-Myc重排B细胞淋巴瘤相关的转化医学

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0 项与 C-Myc重排B细胞淋巴瘤相关的专利（医药）

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项与 C-Myc重排B细胞淋巴瘤相关的文献（医药）

2024-07-04·Blood

Testing for t(3;8) in MYC/BCL6-rearranged large B-cell lymphoma identifies a high-risk subgroup with inferior survival

Article

作者: Maybury, Bernard D. ; Starczynski, Jane ; Chadderton, Nicola ; Kaudlay, Praveen ; Lane, Sarah ; James, Lisa ; Dowds, James ; Moosai, Shivir ; Cherian, George ; Rudzki, Zbigniew ; Haslam, Aidan ; Giles, Hannah ; Chaganti, Sridhar ; Talbot, Georgina ; Vega Gonzalez, Monica ; Crosland, Henry ; Phillips, Neil ; Shenouda, Amir ; Qureshi, Iman ; Venkatadasari, Indrani ; Rakesh, Pallav ; Riley, James ; Davies, David

AbstractA reciprocal t(3;8) BCL6::MYC fusion is common in large B-cell lymphoma (LBCL) with MYC and BCL6 disruption. These pseudo–double-hit cases are not adverse, whereas t(3;8)−MYC/BCL6 lymphoma has an inferior prognosis relative to other MYC-rearranged LBCL.

2024-06-01·Journal of Hematopathology

Cytogenetic and pathologic characterization of MYC-rearranged B-cell lymphomas in pediatric and young adult patients

Article

作者: Sill, Daniel R ; McPhail, Ellen D ; Gagnon, Marie-France ; Ketterling, Rhett P ; Hoppman, Nicole L ; Meyer, Reid G ; Peterson, Jess F ; Bruehl, Frido K ; Xu, Xinjie ; Baughn, Linda B ; King, Rebecca L ; Greipp, Patricia T

AbstractMYC-rearranged B-cell lymphoma (BCL) in the pediatric/young adult (YA) age group differs substantially in disease composition from adult cohorts. However, data regarding the partner genes, concurrent rearrangements, and ultimate diagnoses in these patients is scarce compared to that in adult cohorts. We aimed to characterize the spectrum of MYC-rearranged (MYC-R) mature, aggressive BCL in the pediatric/YA population. A retrospective study of morphologic, immunophenotypic, and fluorescence in situ hybridization (FISH) results of patients age ≤ 30 years with suspected Burkitt lymphoma (BL), diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL), and a MYC-R by FISH between 2013–2022 was performed. Two-hundred fifty-eight cases (129 (50%) pediatric (< 18 years) and 129 (50%) YA (18–30 years)) were included. Most MYC-R BCL in pediatric (89%) and YA (66%) cases were BL. While double-hit (DH) cytogenetics (MYC with BCL2 and/or BCL6-R, HGBCL-DH) was rare in the pediatric population (2/129, 2%), HGBCL-DH increased with age and was identified in 17/129 (13%) of YA cases. Most HGBCL-DH had MYC and BCL6-R, while BCL2-R were rare in both groups (3/258, 1%). MYC-R without an IG partner was more common in the YA group (14/116 (12%) vs 2/128 (2%), p = 0.001). The pediatric to YA transition is characterized by decreasing frequency in BL and increasing genetic heterogeneity of MYC-R BCL, with emergence of DH-BCL with MYC and BCL6-R. FISH to evaluate for BCL2 and BCL6 rearrangements is likely not warranted in the pediatric population but should continue to be applied in YA BCL.

2012-03-15·Cancer1区 · 医学

Prognostic value of MYC rearrangement in cases of B‐cell lymphoma, unclassifiable, with features intermediate between diffuse large B‐cell lymphoma and Burkitt lymphoma

1区 · 医学

Article

作者: Timothy J. Dickason ; Pei Lin ; Roberto Miranda ; Patrick A. Lennon ; Xumei Wang ; Mar Garcia ; Mark J Routbort ; Luis E Fayad ; L Jeffrey Medeiros ; Wei Qiao ; Peter C Hu

AbstractBACKGROUND:B‐cell lymphoma, Unclassifiable with features intermediate between diffuse large B‐cell lymphoma (DLBCL) and Burkitt lymphoma, for convenience referred to here as unclassifiable B‐cell lymphoma, is a category in the 2008 World Health Organization system used for a group of histologically aggressive neoplasms that are difficult to classify definitively. Currently, there is no established standard therapy for these neoplasms.METHODS:The authors assessed MYC status and correlated it with treatment response and outcome in a group of 52 patients with unclassifiable B‐cell lymphoma treated with either a standard DLBCL regimen (R‐CHOP [rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone‐related therapy]) or more intensive regimens, such as R‐hyper‐CVAD (rituximab plus hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high‐dose methotrexate and cytarabine). The regimens were selected by the treating clinicians based on the overall clinical and pathological findings.RESULTS:Thirty (58%) unclassifiable B‐cell lymphomas had MYC abnormalities (MYC+) including 27 with rearrangement, 2 with amplification, and 1 with both. The MYC+ and MYC− groups were similar in their age distribution and International Prognostic Index scores. Progression‐free survival of patients with MYC+ unclassifiable B‐cell lymphoma treated initially with R‐CHOP was significantly worse than patients treated with R‐hyper‐CVAD (P = .0358). In contrast, for the MYC− unclassifiable B‐cell lymphoma group, some patients responded to R‐CHOP, and others were refractory to R‐hyper‐CVAD.CONCLUSIONS:MYC aberrations are common in unclassifiable B‐cell lymphoma. The presence of MYC aberrations identifies a patient subset that requires more aggressive therapy than R‐CHOP. In contrast, MYC− unclassifiable B‐cell lymphoma patients responded variably to either R‐CHOP or aggressive therapy, and the latter showed no survival advantage. Cancer 2011;. © 2011 American Cancer Society.