Risk-adapted, ofatumumab-based chemoimmunotherapy and consolidation in treatment-naive chronic lymphocytic leukemia: a phase 2 study.

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Citation: Leukemia & Lymphoma. 62(8):1816-1827, 2021 08.PMID: 33653216Institution: Washington Cancer InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Leukemia, Lymphocytic, Chronic, B-Cell | Antibodies, Monoclonal, Humanized/tu [Therapeutic Use] | Antineoplastic Combined Chemotherapy Protocols/ae [Adverse Effects] | Humans | Immunotherapy | Leukemia, Lymphocytic, Chronic, B-Cell/di [Diagnosis] | Leukemia, Lymphocytic, Chronic, B-Cell/dt [Drug Therapy] | Treatment OutcomeYear: 2021ISSN:
  • 1026-8022
Name of journal: Leukemia & lymphomaAbstract: High-risk cytogenetics and minimal residual disease (MRD) after chemoimmunotherapy (CIT) predict unfavorable outcome in chronic lymphocytic leukemia (CLL). This phase 2 study investigated risk-adapted CIT in treatment-naive CLL (NCT01145209). Patients with high-risk cytogenetics received induction with fludarabine, cyclophosphamide, and ofatumumab. Those without high-risk cytogenetics received fludarabine and ofatumumab. After induction, MRD positive (MRD+) patients received 4 doses of ofatumumab consolidation. MRD negative (MRD-) patients had no intervention. Of 28 evaluable for response, all responded to induction and 10 (36%) achieved MRD-. Two-year progression-free survival (PFS) was 71.4% (CI95, 56.5-90.3%). There was no significant difference in median PFS between the high-risk and the standard-risk groups. Ofatumumab consolidation didn't convert MRD + to MRD-. In the MRD + group, we saw selective loss of CD20 antigens during therapy. In conclusion, risk-adapted CIT is feasible in treatment-naive CLL. Ofatumumab consolidation didn't improve depth of response in MRD + patients. Loss of targetable CD20 likely reduces efficacy of consolidation therapy.All authors: Ahn IE, Desai S, Drinkwater DC, Farooqui MZ, Gaglione EM, Herman SEM, Hughes TE, Lindorfer MA, Lotter J, Maric I, Marti GE, Mo C, Nichols C, Nierman P, Pleyer C, Soto S, Stetler-Stevenson M, Sun C, Superata J, Taylor RP, Tian X, Valdez J, Wake L, Wiestner A, Yuan CMOriginally published: Leukemia & Lymphoma. :1-17, 2021 Mar 02Fiscal year: FY2022Fiscal year of original publication: FY2021Digital Object Identifier: ORCID: Date added to catalog: 2021-03-10
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Journal Article MedStar Authors Catalog Article 33653216 Available 33653216

High-risk cytogenetics and minimal residual disease (MRD) after chemoimmunotherapy (CIT) predict unfavorable outcome in chronic lymphocytic leukemia (CLL). This phase 2 study investigated risk-adapted CIT in treatment-naive CLL (NCT01145209). Patients with high-risk cytogenetics received induction with fludarabine, cyclophosphamide, and ofatumumab. Those without high-risk cytogenetics received fludarabine and ofatumumab. After induction, MRD positive (MRD+) patients received 4 doses of ofatumumab consolidation. MRD negative (MRD-) patients had no intervention. Of 28 evaluable for response, all responded to induction and 10 (36%) achieved MRD-. Two-year progression-free survival (PFS) was 71.4% (CI95, 56.5-90.3%). There was no significant difference in median PFS between the high-risk and the standard-risk groups. Ofatumumab consolidation didn't convert MRD + to MRD-. In the MRD + group, we saw selective loss of CD20 antigens during therapy. In conclusion, risk-adapted CIT is feasible in treatment-naive CLL. Ofatumumab consolidation didn't improve depth of response in MRD + patients. Loss of targetable CD20 likely reduces efficacy of consolidation therapy.

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