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NCCN Guidelines for Acute Lymphoblastic Leukemia v.1.2021 – Annual on 02/10/2021

Guideline Page Institution Vote Panel Discussion/References

and Request YES NO ABSTAIN ABSENT Internal request: Consider the inclusion of the following statement: “An The panel consensus was to include the statement 22 0 0 6 FDA-approved biosimilar is an appropriate substitute “An FDA-approved biosimilar is an appropriate for rituximab” to be added for all current rituximab substitute for rituximab” for all current rituximab indications in the Guidelines. indications in the Guidelines. This is a category 2A recommendation.

ALL-D 5 of 10 Internal request: The panel consensus was to include + 19 2 1 6 Consider the inclusion of bortezomib + chemotherapy as an option for relapsed/refractory T- as an option for relapsed/refractory T-ALL. ALL. This is a category 2A, other recommended regimen.

Reference: 1. Horton TM, Whitlock JA, Lu X, et al. Bortezomib reinduction chemotherapy in high-risk ALL in first relapse: a report from the Children's Oncology Group. Br J Haematol 2019;186:274-285.

ALL-D 5 of 10 Internal request: The panel consensus was to include HiDAC (high- 19 2 1 6 Consider the inclusion of HiDAC (high-dose ) dose cytarabine) as an option for relapsed/refractory as an option for relapsed/refractory T-ALL. T-ALL. This is a category 2A, other recommended regimen.

ALL-D 5 of 10 Internal request: The panel consensus was to include , 19 2 1 6 Consider the inclusion of mitoxantrone, , and etoposide, and cytarabine as an option for cytarabine as options for relapsed/refractory T-ALL. relapsed/refractory T-ALL. This is a category 2A, other recommended regimen.

Reference: 1. Liedtke M, Dunn T, Dinner S, et al. Salvage therapy with mitoxantrone, etoposide and cytarabine in relapsed or refractory acute lymphoblastic leukemia. Leuk Res 2014;38:1441- 1445.

NCCN Guidelines for Acute Lymphoblastic Leukemia v.1.2021 – Annual on 02/10/2021

ALL-D 5 of 10 Internal request: The panel consensus was to include nelarabine 22 0 0 6 Consider the inclusion of nelarabine alone or in alone or in combination with etoposide and combination with etoposide and as cyclophosphamide as an option for options for relapsed/refractory T-ALL. relapsed/refractory T-ALL. This is a category 2A, preferred recommendation.

References: 1. DeAngelo DJ, Yu D, Johnson JL, et al. Nelarabine induces complete remissions in adults with relapsed or refractory T-lineage acute lymphoblastic leukemia or lymphoblastic lymphoma: Cancer and Leukemia Group B study 19801. Blood 2007;109:5136-5142. 2. Zwaan CM, Kowalczyk J, Schmitt C, et al. Safety and efficacy of nelarabine in children and young adults with relapsed/refractory T-lineage acute lymphoblastic leukaemia or T-lineage lymphoblastic lymphoma: results of phase 4 study. Br J Haematol 2017;179:284-293. 3. Gokbuget N, Basara N, Baumann H, et al. High single-drug activity of nelarabine in relapsed T-lymphoblastic leukemia/lymphoma offers curative option with subsequent stem cell transplantation. Blood 2011;118:3504-3511. 4. Candoni A, Lazzarotto D, Ferrara F, et al. Nelarabine as salvage therapy and bridge to allogeneic stem cell transplant in 118 adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma. A CAMPUS ALL study. Am J Hematol 2020;95:1466-1472. 5. Luskin MR, Ganetsky A, Landsburg DJ, et al. Nelarabine, cyclophosphamide and etoposide for adults with relapsed T-cell acute lymphoblastic leukemia and lymphoma. BR J Haematol 2016;174:332-334. 6. Commander LA, Seif AE, Insogna IG, Rheingold SR. Salvage therapy with nelarabine, etoposide, and cyclophosphamide in relapsed/refractory paediatric T-cell lymphoblastic leukaemia and lymphoma. Br J Haematol 2010;150:345-351. 7. Whitlock J, dalla Pozza L, Goldberg JM, et al. Nelarabine in combination with etoposide and NCCN Guidelines for Acute Lymphoblastic Leukemia v.1.2021 – Annual on 02/10/2021

cyclophosphamide is active in first relapse of childhood T-acute lymphocytic leukemia (T-ALL) and T-lymphoblastic lymphoma (T-LL). Blood 2014;124:795.

ALL-D 5 of 10 Internal request: The panel consensus was to include + 15 6 1 6 Consider the inclusion of venetoclax + chemotherapy chemotherapy (eg, , hyper-CVAD, (eg, decitabine, hyper-CVAD, nelarabine, mini-hyper- nelarabine, mini-hyper-CVD) as an option for CVD) as options for relapsed/refractory T-ALL. relapsed/refractory T-ALL. This is a category 2B, other recommended regimen.

References: 1. Richard-Carpentier G, Jabbour E, Short NJ, et al. Clinical experience with venetoclax combined with chemotherapy for relapsed or refractory T-Cell acute lymphoblastic leukemia. Clin Lymphoma Myeloma Leuk 2020;20:212-218. 2. Parovichnikova E, Gavrilina O, Troitskaya V, et al. Venetoclax plus decitabine in the treatment of MRD-persistent and relapsed/refractory T-cell acute lymphoblastic leukemia. European Hematology Association Congress 2020;EP427. 3. Rubnitz J, Alexander TB, Laetsch TW, et al. Venetoclax and navitoclax in pediatric patients with acute lymphoblastic leukemia and lymphoblastic lymphoma. ASH Annual Meeting Abstracts 2020;Abstract #466. 4. Jain N, Stevenson KE, Winer ES, et al. A multicenter phase I study combining venetoclax with mini-hyper-CVD in older adults with untreated and relapsed/refractory acute lymphoblastic leukemia. Blood 2019;134:3867.

ALL-D 5 of 10 Internal request: The panel consensus was to include regimens for 21 1 0 6 Consider the inclusion of regimens for relapsed/refractory Ph-negative ALL as an option for relapsed/refractory Ph-negative ALL as options for relapsed/refractory T-ALL. This is a category 2A, relapsed/refractory T-ALL. other recommended regimen.

NCCN Guidelines for Acute Lymphoblastic Leukemia v.1.2021 – Annual on 02/10/2021

ALL-D 5 of 10 Internal request: The panel consensus was to include daratumumab 12 8 2 6 Consider the inclusion of the daratumumab as an as an option for relapsed/refractory T-ALL. This is a option for relapsed/refractory T-ALL. category 2B, other recommended regimen.

References: 1. Ofran Y, Ringerstein-Harlev S, Slouzkey I, et al. Daratumumab for eradication of minimal residual disease in high-risk advanced relapse of T-cell/CD19/CD22-negative acute lymphoblastic leukemia. Leukemia 2020;34:293- 295. 2. Ruhayel SD, Valvi S. Daratumumab in T-cell acute lymphoblastic leukemia: A case report and review of the literature. Pediatr Blood Cancer 2020;e28829. 3. Cerrano M, Castella B, Lia G, et al. Immunomodulatory and clinical effects of daratumumab in T-cell acute lymphoblastic leukemia. Br J Haematol 2020;191:e28-e32. 4. Mirgh S, Ahmed R, Agrawal N, et al. Will daratumumab be the next game changer in early thymic precursor-acute lymphoblastic leukemia? Br J Haematol 2019;187:e33-e35. 5. Bonda A, Punatar S, Gokarn A, et al. Daratumumab at the frontiers of post-transplant refractory T-acute lymphoblastic leukemia-a worthwhile strategy? Bone Marrow Transplant 2018;53:1487-1489.