T-cell acute lymphoblastic leukemia
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Nelarabine monotherapy
Regimen variant #1, 5-day dosing
| Study | Years of enrollment | Evidence | Efficacy |
|---|---|---|---|
| Berg et al. 2005 | 1997-2002 | Phase 2 (RT) | ORR: 14-55% |
| Zwaan et al. 2017 (GSK 111081) | 2009-2014 | Phase 4 | ORR: 39% |
Chemotherapy
- Nelarabine (Arranon) 650 mg/m2 IV over 60 minutes once per day on days 1 to 5
21-day cycles
Regimen variant #2, intermittent dosing
| Study | Years of enrollment | Evidence | Efficacy |
|---|---|---|---|
| DeAngelo et al. 2007 (CALGB 19801) | 1998-2001 | Phase 2 (RT) | ORR: 41% (95% CI, 15-43) |
Note: See paper for details about the schedule.
Chemotherapy
- Nelarabine (Arranon) 1500 mg/m2 IV over 2 hours once per day on days 1, 3, 5
21-day cycle for 3 to 4 cycles (or delayed for count recovery)
References
- Berg SL, Blaney SM, Devidas M, Lampkin TA, Murgo A, Bernstein M, Billett A, Kurtzberg J, Reaman G, Gaynon P, Whitlock J, Krailo M, Harris MB; Children's Oncology Group. Phase II study of nelarabine (compound 506U78) in children and young adults with refractory T-cell malignancies: a report from the Children's Oncology Group. J Clin Oncol. 2005 May 20;23(15):3376-82. link to original article contains dosing details in abstract PubMed
- CALGB 19801: DeAngelo DJ, Yu D, Johnson JL, Coutre SE, Stone RM, Stopeck AT, Gockerman JP, Mitchell BS, Appelbaum FR, Larson RA. 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 Jun 15;109(12):5136-42. Epub 2007 Mar 7. link to original article contains dosing details in manuscript link to PMC article PubMed
- GSK 111081: Zwaan CM, Kowalczyk J, Schmitt C, Bielorai B, Russo MW, Woessner M, Ranganathan S, Leverger G. Safety and efficacy of nelarabine in children and young adults with relapsed or refractory T-lineage acute lymphoblastic leukaemia or T-lineage lymphoblastic lymphoma: results of a phase 4 study. Br J Haematol. 2017 Oct;179(2):284-293. Epub 2017 Aug 2. link to original article contains dosing details in manuscript PubMed NCT00866671