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DRUG:

Monjuvi (tafasitamab-cxix)

i
Other names: MOR208, MOR-00208, XmAb5574, XENP-5574, MOR-208, MOR 208, MOR00208, INCMOR0208, ICP-B04, ICPB04, ICP B04, INCMOR-0208, INCMOR 0208, MOR 00208, XENP5574, XENP 5574, XmAb 5574, XmAb-5574
Company:
Incyte, InnoCare, Knight Therap, Specialised Therap, Xencor
Drug class:
CD19 inhibitor
4d
Trial completion • Combination therapy • Pan tumor
|
BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
|
Chr t(11;14) • CCND1 overexpression • BCL6 rearrangement • BCL2 rearrangement
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parsaclisib (INCB50465) • Monjuvi (tafasitamab-cxix)
7d
Trial primary completion date
|
BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
BCL6 rearrangement • BCL2 rearrangement
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carboplatin • lenalidomide • cyclophosphamide • ifosfamide • etoposide IV • Monjuvi (tafasitamab-cxix)
1m
Trial primary completion date
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lenalidomide • Monjuvi (tafasitamab-cxix) • maplirpacept (TTI-622)
1m
VERLen: Study of Tafasitamab and Lenalinomide Associated to Rituximab in Frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or Older (clinicaltrials.gov)
P2, N=71, Active, not recruiting, The Lymphoma Academic Research Organisation | Recruiting --> Active, not recruiting
Enrollment closed
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BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1) • BCL6 (B-cell CLL/lymphoma 6)
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BCL6 rearrangement • BCL2 rearrangement
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Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • Monjuvi (tafasitamab-cxix)
3ms
Trial initiation date
|
Monjuvi (tafasitamab-cxix)
3ms
Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
P1/2, N=4, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=70 --> 4 | Trial completion date: Feb 2029 --> May 2025 | Trial primary completion date: Feb 2027 --> May 2025
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
|
lenalidomide • Monjuvi (tafasitamab-cxix) • maplirpacept (TTI-622)
3ms
Phase classification
|
lenalidomide • Monjuvi (tafasitamab-cxix) • maplirpacept (TTI-622)
3ms
A Study of Tafasitamab and Lenalidomide in People With Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=4, Terminated, Memorial Sloan Kettering Cancer Center | N=39 --> 4 | Trial completion date: Mar 2025 --> Aug 2024 | Recruiting --> Terminated | Trial primary completion date: Mar 2025 --> Aug 2024; Slow accrual rate
Enrollment change • Trial completion date • Trial termination • Trial primary completion date
|
CD19 (CD19 Molecule)
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lenalidomide • Monjuvi (tafasitamab-cxix)
4ms
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders (clinicaltrials.gov)
P1/2, N=47, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting | Initiation date: Nov 2024 --> Jul 2024
Enrollment open • Trial initiation date
|
cyclophosphamide • fludarabine IV • Monjuvi (tafasitamab-cxix)
4ms
New P3 trial • Combination therapy
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gemcitabine • Rituxan (rituximab) • lenalidomide • oxaliplatin • Monjuvi (tafasitamab-cxix)
4ms
Trial completion
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Rituxan (rituximab) • bendamustine • Monjuvi (tafasitamab-cxix)
5ms
Enrollment open
|
Monjuvi (tafasitamab-cxix)
5ms
Blockade of the CD47/SIRPα checkpoint axis potentiates the macrophage-mediated anti-tumor efficacy of tafasitamab. (PubMed, Haematologica)
Macrophages are one of the key mediators of the therapeutic effects exerted by monoclonal antibodies, such as the anti-CD19 antibody tafasitamab, approved in combination with lenalidomide for the treatment of relapsed or refractory (r/r) diffuse large B cell lymphoma (DLBCL). Finally, combined treatment of tafasitamab and an anti-CD47 antibody resulted in enhanced tumor volume reduction and survival benefit in lymphoma xenograft mouse models. These findings provide evidence that CD47 blockade can enhance the phagocytic potential of tumor targeting immunotherapies such as tafasitamab and suggest there is value in exploring the combination in the clinic.
Journal • IO biomarker
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CD19 (CD19 Molecule) • CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
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lenalidomide • Monjuvi (tafasitamab-cxix)
5ms
New P2 trial
|
Monjuvi (tafasitamab-cxix)
6ms
New P1/2 trial
|
cyclophosphamide • fludarabine IV • Monjuvi (tafasitamab-cxix)
6ms
ZANU-TAFA: Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma (clinicaltrials.gov)
P1/2, N=27, Recruiting, Alvaro Alencar, MD | Not yet recruiting --> Recruiting
Enrollment open
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Brukinsa (zanubrutinib) • Monjuvi (tafasitamab-cxix)
6ms
Phase II MOR00208 in Combination With Lenalidomide for Patients With Relapsed or Refractory CLL, SLL or PLL or Older Patients With Untreated CLL, SLL or PLL (clinicaltrials.gov)
P2, N=41, Active, not recruiting, Ohio State University Comprehensive Cancer Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy
|
Imbruvica (ibrutinib) • lenalidomide • Monjuvi (tafasitamab-cxix)
6ms
Enrollment closed
|
CD19 positive
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lenalidomide • Monjuvi (tafasitamab-cxix)
6ms
MTR²: Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL (clinicaltrials.gov)
P2, N=20, Not yet recruiting, University of Cologne | Trial completion date: Jul 2026 --> Apr 2027 | Trial primary completion date: May 2026 --> Feb 2027
Trial completion date • Trial primary completion date
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Rituxan (rituximab) • lenalidomide • Monjuvi (tafasitamab-cxix)
7ms
Phase classification • Combination therapy
|
Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • parsaclisib (INCB50465) • Monjuvi (tafasitamab-cxix)
7ms
Sequencing of anti-CD19 therapies in the management of diffuse large B-cell lymphoma. (PubMed, Clin Cancer Res)
The anti-CD19 monoclonal antibody tafasitamab, paired with the immunomodulator lenalidomide, mediates antibody-dependent cellular toxicity and cellular phagocytosis; the antibody-drug conjugate loncastuximab tesirine delivers the DNA-cross-linking agent tesirine via CD19 binding and internalization; and CD19-directed chimeric antigen receptor T-cell therapy (CAR-T) products are engineered from autologous T cells. To date, clinical evidence on the effect of anti-CD19 therapy prior to CAR-T is restricted to small case series. Prospective studies and detailed analyses to understand how pre- and post-treatment CD19 expression correlates with clinical responses to subsequent CD19-directed therapy are needed to fully maximize treatment strategies.
Journal • IO biomarker
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CD19 (CD19 Molecule)
|
CD19 expression
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lenalidomide • Zynlonta (loncastuximab tesirine-lpyl) • Monjuvi (tafasitamab-cxix)
7ms
Asciminib Maintains Antibody-Dependent Cellular Cytotoxicity against Leukemic Blasts. (PubMed, Cancers (Basel))
The introduction of rituximab has improved the outcomes in CD20 positive cases. Other monoclonal antibodies, such as tafasitamab (anti-CD19), obinutuzumab (anti-CD20) and epratuzumab (anti-CD22) have been tested in trials (NCT05366218, NCT04920968, NCT00098839)...In contrast to ATP site inhibitors such as dasatinib and ponatinib, the novel first-in-class selective allosteric ABL myristoyl pocket (STAMP) inhibitor asciminib did not significantly impact ADCC in our settings. Our results suggest that asciminib should be considered in clinical trials.
Journal
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
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BCR-ABL1 fusion • CD20 positive
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dasatinib • Rituxan (rituximab) • Iclusig (ponatinib) • Gazyva (obinutuzumab) • Scemblix (asciminib) • Monjuvi (tafasitamab-cxix) • Epratucyn (epratuzumab)
8ms
CCTG LY18-A: Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma (clinicaltrials.gov)
P1, N=18, Recruiting, Canadian Cancer Trials Group | Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date • Combination therapy
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Venclexta (venetoclax) • cisplatin • gemcitabine • dexamethasone • Rituxan Hycela (rituximab/hyaluronidase) • Monjuvi (tafasitamab-cxix) • Columvi (glofitamab-gxbm)
8ms
New trial • Combination therapy • Real-world evidence • Real-world
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lenalidomide • Monjuvi (tafasitamab-cxix)
9ms
Trial primary completion date
|
Rituxan (rituximab) • lenalidomide • Monjuvi (tafasitamab-cxix)
9ms
Phase classification
|
Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • parsaclisib (INCB50465) • Monjuvi (tafasitamab-cxix)
9ms
Trial initiation date
|
Monjuvi (tafasitamab-cxix)
9ms
CCTG LY18-A: Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma (clinicaltrials.gov)
P1, N=18, Recruiting, Canadian Cancer Trials Group | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy
|
Venclexta (venetoclax) • cisplatin • gemcitabine • dexamethasone • Rituxan Hycela (rituximab/hyaluronidase) • Monjuvi (tafasitamab-cxix) • Columvi (glofitamab-gxbm)
10ms
V-MIND: Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
P2, N=100, Recruiting, Academic and Community Cancer Research United | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
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CD19 (CD19 Molecule) • CCND1 (Cyclin D1)
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Chr t(11;14) • CCND1 overexpression • CD19 expression • Chr t(11;14)(q13;q32)
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Venclexta (venetoclax) • lenalidomide • Monjuvi (tafasitamab-cxix)
10ms
Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma (clinicaltrials.gov)
P1/2; Trial completion date: Apr 2023 --> Jun 2026 | Trial primary completion date: Apr 2023 --> Sep 2025
Trial completion date • Trial primary completion date
|
clonoSEQ
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lenalidomide • Monjuvi (tafasitamab-cxix)
11ms
topMIND: A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov)
P1/2, N=54, Active, not recruiting, Incyte Corporation | Phase classification: P1b/2a --> P1/2 | Trial completion date: Oct 2023 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Dec 2024
Phase classification • Trial completion date • Trial primary completion date • Combination therapy • Pan tumor
|
BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
|
Chr t(11;14) • CCND1 overexpression • BCL6 rearrangement • BCL2 rearrangement
|
parsaclisib (INCB50465) • Monjuvi (tafasitamab-cxix)
11ms
Phase classification
|
lenalidomide • Monjuvi (tafasitamab-cxix) • maplirpacept (TTI-622)
11ms
realMIND: Observational Study on Safety and Effectiveness of Tafasitamab in Combination With Lenalidomide in Patients With Relapsed or Refractory DLBCL (clinicaltrials.gov)
P=N/A, N=100, Recruiting, MorphoSys AG | N=1000 --> 100 | Trial completion date: Jul 2029 --> Aug 2026 | Trial primary completion date: Jul 2028 --> Oct 2025
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
|
BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
|
BCL6 translocation • BCL2 translocation
|
lenalidomide • Monjuvi (tafasitamab-cxix)
11ms
Allogeneic CD6 Chimeric Antigen Receptor T Regulatory Cells (CD6-CAR Tregs) for the Treatment of Patients With Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Cell Transplantation (clinicaltrials.gov)
P1, N=27, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting | Trial completion date: May 2027 --> May 2028 | Trial primary completion date: May 2027 --> May 2028
Enrollment open • Trial completion date • Trial primary completion date
|
Monjuvi (tafasitamab-cxix)
12ms
Contemporary Treatment Options Beyond Chimeric Antigen Receptor (CAR) T-Cell Therapies for Patients with Relapsed or Refractory Large B-Cell Lymphoma (LBCL): A Systematic Literature Review (SLR) (TCT-ASTCT-CIBMTR 2024)
We performed an SLR to understand the efficacy and real-world (RW) effectiveness of non–CAR T-cell therapies for R/R LBCL including tafasitamab with lenalidomide (tafa/len), polatuzumab with bendamustine/rituximab (pola-BR), loncastuximab, selinexor, epcoritamab, and glofitamab. Currently, the evidence base, particularly RW studies, for non–CAR T-cell R/R LBCL therapies is still limited. In comparison, 78 RW CAR T-cell therapy studies were published (Jacobson et al. Tandem Meeting.
Clinical • Review
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Rituxan (rituximab) • lenalidomide • Xpovio (selinexor) • Kymriah (tisagenlecleucel-T) • bendamustine • Epkinly (epcoritamab-bysp) • Zynlonta (loncastuximab tesirine-lpyl) • Monjuvi (tafasitamab-cxix) • Polivy (polatuzumab vedotin-piiq) • Columvi (glofitamab-gxbm)
12ms
Introduction of Glofitamab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) after ≥2 Lines of Systemic Therapy Results in Cost Savings to the Healthcare System Based on a United States Budget Impact Analysis (ASH 2023)
Comparators were axicabtagene ciloleucel (Axi-cel), lisocabtagene maraleucel (Liso-cel), tisagenlecleucel (Tisa-cel), loncastuximab tesirine (Lonca), polatuzumab vedotin + bendamustine + rituximab (Pola-BR), rituximab + gemcitabine + oxaliplatin (R-GemOx), tafasitamab + lenalidomide, and epcoritamab. Over 3 years, the estimated cumulative per-patient cost of glofitamab is projected to be the lowest when compared with per-patient costs of other available T-cell engaging therapies, resulting in cost savings after its formulary adoption for the treatment of R/R DLBCL after ≥2 lines of therapy.
HEOR
|
gemcitabine • Rituxan (rituximab) • lenalidomide • oxaliplatin • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • bendamustine • Epkinly (epcoritamab-bysp) • Zynlonta (loncastuximab tesirine-lpyl) • Monjuvi (tafasitamab-cxix) • Polivy (polatuzumab vedotin-piiq) • Columvi (glofitamab-gxbm)
12ms
Practice Efficiency Associated with Epcoritamab for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma from an Institutional Perspective (ASH 2023)
A micro-costing analysis was developed to compare practice efficiency of treating patients with R/R DLBCL using epcoritamab versus comparator treatments (glofitamab, polatuzumab/bendamustine/rituximab [pola-BR], tafasitamab/lenalidomide [tafa-len], and axicabtagene ciloleucel [axi-cel]) over a time horizon of up to 1 year. Due to its unique SC administration, epcoritamab improves institutional practice efficiency despite more frequent dosing, saving personnel costs and inpatient costs. This could help to alleviate capacity constraints at infusion centers and ease patient scheduling. The resources saved (staff time, chair time, inpatient monitoring) can be redirected to other institutional needs, improving the availability and quality of healthcare services for patients.
Clinical
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Rituxan (rituximab) • lenalidomide • Yescarta (axicabtagene ciloleucel) • bendamustine • Epkinly (epcoritamab-bysp) • Monjuvi (tafasitamab-cxix) • Polivy (polatuzumab vedotin-piiq) • Columvi (glofitamab-gxbm)
12ms
Affinity of Anti-CD19 Antibodies Determines Subsequent CART19 Activation, Apoptosis and CRS in Preclinical Models (ASH 2023)
Western blot analysis of splenocytes revealed that G1, 3, and 4 showed significantly lower expression of apoptosis-inducing protein gasdermin E on leukemic cells compared to G2, indicating reduced tumor pyroptosis in G2. In summary, application of the high affinity mAb tafasitamab prior to CART19 resulted in reduced CAR T apoptosis, diminished tumor cell pyroptosis, and reduction of CRS compared to lower affinity CD19 mAbs in preclinical models.
Preclinical
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CD20 (Membrane Spanning 4-Domains A1) • IFNG (Interferon, gamma) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • IL10 (Interleukin 10) • HMGB1 (High Mobility Group Box 1) • ANXA5 (Annexin A5) • GSDME (Gasdermin E)
|
Monjuvi (tafasitamab-cxix)
12ms
A Multicenter, Open-Label, Phase 1b/2 Study to Evaluate the Effects of Maplirpacept in Combination with Tafasitamab and Lenalidomide in People with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (ASH 2023)
Participants must provide a baseline tumor tissue sample (fresh or archival), for biomarker analysis. Exclusion criteria include previous treatment with anti-CD47, anti-CD19 (other than CAR-T) or immunomodulatory agents, prior allogeneic stem cell transplantation or autologous stem cell transplantation within 12 weeks prior to enrolment, and participants with active, uncontrolled viral, bacterial or fungal infections.
Clinical • P1/2 data • Combination therapy • IO biomarker
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lenalidomide • Monjuvi (tafasitamab-cxix) • maplirpacept (TTI-622)
12ms
Realmind: A Prospective and Retrospective Study to Characterize Real-World Use of Tafasitamab Plus Lenalidomide in US Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma, with a Focus on Patients from Minority Groups (ASH 2023)
Study statusThe in-progress non-interventional realMIND study is expected to end by approximately December 2025, or earlier, when: ≥50 patients treated with tafasitamab + LEN have been recruited into each of Group 1 and Group 2 with either prospective or retrospective data collection; and all prospectively-followed patients have ≥6 months follow-up after starting tafasitamab treatment, or have discontinued from the study for any reason, whichever occurs earlier. The results are anticipated to describe the real-world safety and effectiveness of tafasitamab for R/R DLBCL in US patients, with a focus on underrepresented racial and ethnic minorities, to help optimize outcomes of treatment and identify opportunities for further studies.
Retrospective data • Real-world evidence • Real-world
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lenalidomide • Monjuvi (tafasitamab-cxix)
12ms
MINDway: Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients (clinicaltrials.gov)
P1/2, N=51, Recruiting, MorphoSys AG | Phase classification: P1b/2 --> P1/2 | Trial completion date: Feb 2027 --> Oct 2027 | Trial primary completion date: May 2024 --> Nov 2024
Phase classification • Trial completion date • Trial primary completion date
|
CD19 positive
|
lenalidomide • Monjuvi (tafasitamab-cxix)
1year
SECONDARY MYELOID NEOPLASM (SMN) IN DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) SURVIVORS, A SINGLE CENTER RECENT EXPERIENCE (SIE 2023)
Survivors of DLBCL have an increased risk of secondary primary malignancies; previous studies found that incidence of acute myeloid leukaemia (AML) nearly doubled in the post rituximab era...Due to severe chronic obstructive pulmonary disease, autologous transplant was excluded, thus request for Tafasitamablenalidomide under an extended access program was sent and approved in July 2022. After two cycles, lenalidomide was reduced because of grade 3-4 neutropenia poorly responsive to G-CSF...Patient started decitabine plus venetoclax protocol that is still ongoing...Patient has been candidated to allogenic transplant and azacitidine is now ongoing...Recently, the risk of SMN is also of particular concern in the CAR-T receivers. In conclusion a better comprehension of SPM/SMN pathology in DLBCL survivors is needed in order to guide the best “tailored” surveillance.
Clinical • IO biomarker
|
ETV6 (ETS Variant Transcription Factor 6)
|
Venclexta (venetoclax) • Rituxan (rituximab) • lenalidomide • azacitidine • decitabine • Monjuvi (tafasitamab-cxix) • methotrexate IV