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IACH NEWS OF THE WEEK

June 18, 2026
Prepared by Dr Edwin Uriel Suárez

Prospective phase II study of frontline Helicobacter pylori eradication therapy for early-stage extragastric mucosa-associated lymphoid tissue lymphoma. 

Highlights:

-        The links between the colonization of Helicobacter pylori (HP) and extragastric areas has been reported in the following extragastric sites: eye, nasal cavity, middle ear, oral cavity, coronary artery, liver, peritoneum, large intestine, gall bladder, and skin.

-        The current study showed that a proportion of patients with extragastric mucosa-associated lymphoid tissue (MALT) lymphoma are responsive to frontline HP eradication regimens (HPE), especially in cases of positive HP infection or ocular adnexal MALT lymphoma (OAML).

 

In this study, 26 patients with localized extragastric MALT lymphoma, with a median age of 54 years (range, 33–90), between 2016 and 2020 were included. Positive gastric HP infection in 12 patients was further verified by the 13C-urea breath test (n=8), and histology/rapid urease testing of gastric biopsy samples (n=8). Of the 26 patients who received frontline HPE, the authors revealed that 10 (38.5%) achieved complete response (CR) and seven (26.9%) achieved  partial response (PR), with an overall response rate of 65.4% (95% confidence interval, 45.8% to 85.0%). Among 15 patients with ocular adnexal MALT lymphoma, eight with conjunctival and one with orbital MALT lymphoma achieved CR, whereas two with conjunctival and one with OAML achieved PR. The presence of t(11;18)(q21;q21) was significantly higher in antibiotic non-responders than in antibiotic responders (5/9 [55.6%] vs. 2/17 [11.8%], P=0.028). 

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Diagnosis of primary CNS lymphoma through molecular and immune biomarkers in cerebrospinal fluid (PRICELUS): a multicentre, prospective, cohort study.

Highlights:

-        Emerging cerebrospinal fluid (CSF) biomarkers, including the myeloid differentiation primary response 88 (MYD88) L265P mutation in CSF and several chemokines, might improve diagnostic accuracy in primary CNS lymphoma, but evidence mostly comes from retrospective, nonconsecutive cohorts.

-        This study validates the diagnostic utility of CSF biomarkers (MYD88, interleukin-10 [IL-10], and C-X-C motif chemokine ligand 13 [CXCL13]) remained independently associated with a CNS lymphoma diagnosis.

 

Of 255 patients (median age 61 years [IQR 52–72]), 50 (20%) were diagnosed with CNS lymphoma; 44 had primary CNS lymphoma and six were diagnosed with secondary CNS lymphoma. Combining a positive MYD88 result with elevated IL-10 or CXCL13 (or both) yielded a sensitivity of 54.0% (27 of 50; 95% confidence interval [CI] 39.3–68.2) with specificity of 100.0% (95% CI 98.2–100.0). A negative result for all three biomarkers provided a negative predictive value of 99.4% (162 of 163). In selected clinical scenarios and with further validation of these results, combined CSF biomarker testing might support noninvasive diagnostic decision making and reduce reliance on brain biopsy, a procedure with risks and diagnostic delay.

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All-Oral Treatment of Newly Diagnosed Acute Myeloid Leukemia (phase 1–2 clinical trial). 

Highlights:

-        For patients with acute myeloid leukemia (AML) who are ≥75 years of age or who are ineligible for intensive induction chemotherapy, azacitidine or decitabine plus venetoclax is the standard of care, but parenteral administration imposes a burden on patients and providers.

-        Oral decitabine–cedazuridine, approved in Europe for AML, has pharmacokinetic properties equivalent to those of intravenous decitabine but provides limited survival benefit as monotherapy.

-        Among patients with newly diagnosed AML who were ineligible for intensive chemotherapy, all-oral decitabine–cedazuridine plus venetoclax caused no drug interactions and resulted in a complete response (CR) in nearly half the patients, with myelosuppressive effects.

 

In this study (ASCERTAIN-V), a total of 189 patients with newly diagnosed AML who were ≥75 years of age or who were enrolled to receive oral decitabine-cedazuridine plus oral venetoclax (30 patients in phase 1, 58 patients in phase 2a, and 101 patients in phase 2b). No drug–drug interactions were observed between decitabine–cedazuridine and venetoclax. In the pivotal phase 2b, the percentage of patients with a CR was 47% (95% confidence interval [CI], 36 to 57), the percentage with a CR or CR with incomplete hematologic recovery was 63% (95% CI, 53 to 73), and median overall survival was 15.5 months (95% CI, 7.6 to could not be estimated). Common adverse events of grade ≥3 in phase 2b were anemia (in 30% of the patients), neutropenia (in 26%), and febrile neutropenia (in 25%). Mortality was 3% at 30 days and 10% at 60 days.

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Defining lines of therapy in haematological malignancies: a proposed systematic and comprehensive framework from the EBMT Practice Harmonisation and Guidelines Committee (Perspective from Bone Marrow Transplantation journal).

The therapeutic landscape of hematological malignancies has been transformed by targeted therapies, immunotherapy, and cellular therapies, leading to more complex and prolonged clinical courses. Currently, there is substantial variability in how “lines of therapy” (LoT) are defined and recorded, which hinders research and data harmonization. To address this, the European Society for Blood and Marrow Transplantation Practice Harmonisation and Guidelines Committee has developed a standardized framework for LoT across acute leukemias, lymphomas, and multiple myeloma.  See disease-specific examples for acute leukemias (Figure 1), for lymphomas (Figure 2), and for multiple myeloma (Figure 3) in original paper.

 

Key points:

-        An LoT is a coherent therapeutic episode initiated to achieve, reachieve, or maintain disease control, characterized by a dominant intent (curative, disease-controlling, or palliative), and composed of one or more sequential systemic treatment phases administered without occurrence of disease progression or treatment failure or major toxicity requiring a change in treatment.

●      Induction constitutes the initial therapeutic phase, aimed at achieving remission through the eradication or substantial reduction of malignant cells.

●      Once remission is achieved, consolidation therapy follows to eliminate residual disease and deepen response, often employing intensified chemotherapy, targeted agents, and haematopoietic cell transplantation or cellular therapies.

●      Maintenance therapy is subsequently administered to sustain remission and delay relapse, typically through lower-intensity or continuous regimens designed to suppress residual clonal activity.

-        Other therapeutic treatment phases include holding or bridging therapy that encompasses any systemic treatment delivered before a planned definitive therapeutic intervention, such as chimeric antigen receptor T cells (CAR T).

●      Holding therapies are defined as those administered between the identification of the need for CAR T and leukapheresis.

●      Bridging therapies are those delivered between leukapheresis and subsequent CAR T infusion.

-        Salvage therapy refers to the administration of a new regimen following relapse, progression, or treatment failure, with the objective of reinducing remission, prolonging disease control, or providing palliation. An LoT is considered ended when there is disease progression, relapse, or treatment failure. 

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Isatuximab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma: dynamics of MRD negativity in the IMROZ study

Highlights:

-        Quadruplet therapy with Isa-VRd (isatuximab, Velcade [bortezomib], Revlimid [lenalidomide], and dexamethasone) followed by Isa-Rd in the randomized phase 3 IMROZ study, provided a significant progression-free survival benefit to transplant-ineligible patients with newly diagnosed multiple myeloma .

-        Isa-VRd/Isa-Rd led to higher minimal residual disease (MRD) negativity and MRD-negative complete response rates after induction vs. VRd/Rd, with rates increasing during maintenance.

-        Isa-VRd/Isa-Rd was also associated with a lower rate of conversion from MRD negativity to MRD positivity vs. VRd/Rd.

 

Here, the authors report landmark analysis results of analyses conducted to assess the dynamics of MRD negativity over time, sustained MRD negativity for ≥24 months, and its impact on clinical outcomes in patients treated with Isa-VRd induction followed by Isa-Rd maintenance vs. VRd followed by Rd in the IMROZ study. Treatment with Isa-VRd/Isa-Rd led to deeper responses at the end of induction and during maintenance vs. VRd/Rd, up to 60 months of follow-up. Benefit with Isa-VRd/Isa-Rd was observed across key patient subgroups, including older (>70 years) and frail patients. Time to progression was significantly prolonged with Isa-VRd/Isa-Rd vs. VRd/Rd in patients who converted from MRDnegative to MRDpositive at any time point.

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Does ciltacabtagene autoleucel have a future in multiple myeloma? (Comment from Nature Reviews Clinical Oncology journal).

Ciltacabtagene autoleucel (cilta-cel) has transformed the outcomes of patients with relapsed or refractory multiple myeloma, yet its toxicity profile — spanning acute and delayed-onset neurotoxicity, secondary malignancies, immune effector-cell colitis, infections and prolonged cytopenias — has emerged slowly. As safer alternatives become available, the risk–benefit calculus for cilta-cel demands urgent reassessment, particularly in earlier lines of therapy.

 

As B-cell maturation antigen-targeted and other novel therapies mature, regulatory frameworks and post-marketing surveillance infrastructure must evolve accordingly. The development of cilta-cel is ultimately a triumph of efficacy and a lesson highlighting the urgent need for improved safety surveillance — and a reminder that for patients receiving earlier lines of therapy with access to effective alternatives, unprecedented responses alone may not be a sufficient justification for accepting clinically serious and potentially irreversible toxicities.

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