Phase 2 trial of brentuximab vedotin and gemcitabine for pediatric and young adult patients with relapsed or refractory Hodgkin lymphoma (HL): A Children’s Oncology Group (COG) report.

Authors

Peter Cole

Peter D. Cole

The Children's Hospital at Montefiore, Bronx, NY

Peter D. Cole , Kathleen McCarten , Monika Metzger , Richard A. Drachtman , Terzah M. Horton , Qinglin Pei , Rizvan Bush , Susan Blaney , Brenda Weigel , Kara M. Kelly

Organizations

The Children's Hospital at Montefiore, Bronx, NY, Rhode Island Hospital, Providence, RI, St. Jude Children's Research Hospital, Memphis, TN, Cancer Institute of New Jersey, New Brunswick, NJ, Baylor College of Medicine, Houston, TX, Children's Oncology Group, Gainesville, FL, Children's Oncology Group, Monrovia, CA, Texas Children's Cancer Center, Baylor College of Medicine, Houston, TX, University of Minnesota, Minneapolis, MN, Roswell Park Cancer Institute, Buffalo, NY

Research Funding

NIH

Background: AHOD1221 (NCT01780662) tested Brentuximab vedotin (Bv) with gemcitabine (GEM) in children or young adults with HL. The primary objective was to describe the complete response (CR) rate within 4 cycles of therapy. Methods: Eligibility criteria included age ≤30 years; no prior Bv exposure; and primary refractory HL or advanced stage disease with early relapse. Each 21-day cycle consisted of Bv on day 1 at the recommended phase 2 dose (RP2D), 1.8 mg/kg and GEM 1000mg/m2 on days 1 and 8. Patients were evaluable for response if they completed 4 cycles of Bv+GEM, had a CR after 2 cycles, or progressive disease at any time. Response was assessed after even cycles, and confirmed by central review. CR was defined by FDG-PET negativity (Deauville 1-2) regardless of residual lesion size. Results: 42 patients were treated with Bv+GEM. Median age was 17.4 years (range 5.4-28.7), and 23 (55%) were female. The majority (n=35; 83%) had primary refractory disease or early relapse <6 months after completion of primary treatment. Common (>10%) adverse events included maculopapular rash (36% in cycle 1), neutropenia (33%) and elevated serum transaminases (21%). GCSF-stimulated peripheral blood stem cell (PBSC) collection was successful in all patients (n=23) for whom it was attempted, with median total collection of 9.4x106CD34+ cells/kg (range 3.5-36.8). 23 of 40 evaluable patients experienced a CR (58%; 95% CI 42-73%) within four cycles, and 6 had a partial response (PR), for an ORR of 73% (95% CI, 59-86%). For 4 patients with PR or stable disease, all target lesions were Deauville 3 or less after cycle 4, considered a CR by modern response criteria (Cheson et al. Blood 2016;128(21): 2489). Conclusions: Bv+GEM is a highly active combination for primary refractory or high-risk relapse of HL, with a CR rate exceeding that seen after either Bv (34%) or GEM (9%) alone. PBSCs can be collected successfully following Bv+GEM, making this an effective reinduction regimen when autologous stem cell transplantation is indicated. Compared to alternate retrieval regimens, Bv+GEM offers the advantage of avoiding agents associated with late treatment sequelae. Clinical trial information: NCT01780662

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Abstract Details

Meeting

2017 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Track

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Sub Track

Hodgkin Lymphoma

Clinical Trial Registration Number

NCT01780662

Citation

J Clin Oncol 35, 2017 (suppl; abstr 7527)

DOI

10.1200/JCO.2017.35.15_suppl.7527

Abstract #

7527

Poster Bd #

289

Abstract Disclosures