Circulating microRNAs: promising biomarkers in aplastic anemia

Subcutaneous Rituximab for the Treatment of B-Cell Hematologic Malignancies: A Review of the Scientific Rationale and Clinical Development

“… Cycle 1 R-IV 375 mg/m 2 ; Cycles 2-8 R-SC 1400 mg. Maintenance I: R-SC 1400 mg q8w for 2 years in patients with ≥ PR following induction Maintenance II c : R-SC 1400 mg q8w until disease progression (control arm: observation) 216 b MabRella [ 54 ] (NCT01987505) Phase IIIb, open-label, single-arm, safety umbrella study Previously untreated DLBCL or FL FL/DLBCL induction: q2w, q3w or q4w rituximab in combination with standard chemotherapy for 4– 7 cycles Cycle 1 R-IV 375 mg/m 2 ; Cycles 2-8 R-SC 1400 mg FL maintenance: R-SC 1400 mg q2 m for 6–12 cycles 336 C trough trough (pre-dose) concentration, CHOP cyclophosphamide, vincristine, doxorubicin, prednisone, CLL chronic lymphocytic leukemia, CR complete response, CVP cyclophosphamide, vincristine, prednisone, DLBCL diffuse large B-cell lymphoma, FC fludarabine and cyclophosphamide, FL follicular lymphoma, I indolent, IV intravenous, NHL non-Hodgkin lymphoma, PR partial response, q2 m every 2 months, q3 m every 3 months, q2w once every 2 weeks, q3w once every 3 weeks, q4w once every 4 weeks, q8w once every 8 weeks, R rituximab, SC subcutaneous a Patients were randomized to receive either rituximab SC at cycles 2–4 (after the first cycle rituximab IV) or rituximab IV at cycles 1–4. After the fourth cycle, patients were crossed over to the alternative route of administration for the remaining four cycles b At interim analysis; more currently enrolled c Patients maintaining CR/PR at the end of the standard 2 years of rituximab SC maintenance will be randomized to additional maintenance treatment with rituximab SC or observation (Maintenance II) …”

“…In total, 28% of patients experienced an ARR after one dose of rituximab IV, while 41% of patients had reported an ARR after a median of five cycles of rituximab SC. The phase IIIb MabRella safety study is specifically investigating ARRs following multiple doses of rituximab SC in combination with chemotherapy for the first-line or maintenance treatment of patients with NHL (Table 1 ) [ 54 ]. Preliminary results indicate an overall safety profile in keeping with previous reports, with neutropenia, asthenia, erythema, and pyrexia the most common adverse events.…”

Treatment of relapsed and refractory multiple myeloma

“…Dara-Vd was effective regardless of age, ISS stage, renal failure, and cytogenetic risk [ 59 ]. In the POLLUX and CASTOR trials, a significant rate of MRD negativity was achieved across both high and standard cytogenetic risk patients [ 60 ]. Phase III studies comparing Dara (intravenous or subcutaneous)-Pd with Pd (APOLLO, NCT 03180736), Dara-Kd with Kd (CANDOR, NCT 03158688), and Dara intravenous versus subcutaneous administrations (COLUMBA, NCT 03277105) are currently ongoing.…”

Targeting Leukemia Stem Cells in the Bone Marrow Niche

“…A phase 1b/randomized phase 2a clinical trial of indoximod in combination with idarubicin over three days and cytarabine over seven days (3 + 7) is actively recruiting patients with newly diagnosed AML aged >18 years with targeted completion in 2018 (clinicaltrials.gov identifier: NCT02835729). Results of the phase I portion of the clinical trial have shown that incorporation of indoximod into conventional remission induction and consolidation is well tolerated without adding significant toxicity and may improve clinical outcome [ 110 ]. As of 1 March 2017, five of six (83%) evaluable patients achieved MRD-negative CR after induction and remained MRD-negative after the first cycle of consolidation with high-dose cytarabine.…”