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AJH: Decitabine and Vorinostat in Combination with FLAG Chemotherapy for Pediatric Relapsed/Refractory AML: A Treatment Progress Report from the Childhood Leukemia and Lymphoma (TACL) Consortium

 Last Update: 2022-04-22
 Source: Internet
 Author: User

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Survival outcomes in relapsed/refractory pediatric acute myeloid leukemia (R/R AML) are dismal
.

Epigenetic changes can lead to altered gene expression, which is thought to contribute to leukemogenesis and resistance to chemotherapy

Survival outcomes in relapsed/refractory pediatric acute myeloid leukemia (R/R AML) are dismal

Investigators report results from a phase I trial in which a dose-expansion cohort studied decitabine and vorinostat in combination with fludarabine, cytarabine, and G-CSF(FLAG) R/R AML Pediatric Patients [NCT02412475]

Table: Summary of optimal response to decitabine dose levels and epigenetic alterations

The recommended Phase 2 dose of decitabine in combination with vorinostat and FLAG is 10 mg/m ²
.

The expanded cohort design allowed for efficacy evaluation, with an overall response rate of 54% in 35 evaluable patients (16 complete responses (CR) and 3 complete responses with incomplete hematologic recovery (CRi))

The recommended Phase 2 dose of decitabine in combination with vorinostat and FLAG is 10 mg/m ²

The 2-year overall survival rate was 75.

Of the 12 subjects (34%) with known epigenetic alterations, 8 (67%) achieved CR and 7 (88%) were MRD negative
.

Correlative pharmacodynamics demonstrated the biological activity of decitabine and vorinostat and identified specific gene enrichment signatures in non-responsive patients

Of the 12 subjects (34%) with known epigenetic alterations, 8 (67%) achieved CR and 7 (88%) were MRD negative

Overall, decitabine and vorinostat combined with FLAG chemotherapy were well tolerated, biologically active, and effective in pediatric patients with R/R AML, especially those with epigenetic alterations

Original source:

Pommert, L.

, Schafer, ES, Malvar, J.
, Gossai, N.
, Florendo, E.
, Pulakanti, K.

Pommert, L.
, Schafer, ES, Malvar, J.
, Gossai, N.
, Florendo, E.
, Pulakanti, K.
, Heimbruch, K.
, Stelloh, C.
, Chi, Y.
-Y.
, Sposto, R .
, Rao, S.
, Huynh, VT, Brown, P.
, Chang, BH, Colace, SI, Hermiston, ML, Heym, K.
, Hutchinson, RJ, Kaplan, JA, Mody, R.
, O'Brien, TA, Place, AE, Shaw, PH, Ziegler, DS, Wayne, A.
, Bhojwani, D.
and Burke, MJ (2022), Decitabine and Vorinostat with FLAG Chemotherapy in Pediatric Relapsed/Refractory AML: Report from the Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) Consortium.
Am J Hematol.
Accepted Author Manuscript.
https://doi.
org/10.
1002/ajh.
26510Pommert, L.
, Schafer, ES, Malvar, J.
, Gossai, N.
, Florendo, E.
, Pulakanti, K.
, Heimbruch, K.
, Stelloh, C.
, Chi, Y.
-Y.
, Sposto, R .
, Rao, S.
, Huynh, VT, Brown, P.
, Chang, BH, Colace, SI, Hermiston, ML, Heym, K.
, Hutchinson, RJ, Kaplan, JA, Mody, R.
, O'Brien, TA, Place, AE, Shaw, PH, Ziegler, DS, Wayne, A.
, Bhojwani, D.
and Burke, MJ (2022), Decitabine and Vorinostat with FLAG Chemotherapy in Pediatric Relapsed/Refractory AML: Report from the Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) Consortium.
Am J Hematol.
Accepted Author Manuscript.
https://doi.
org/10.
1002/ajh.
26510Pommert, L.
, Schafer, ES, Malvar, J.
, Gossai, N.
, Florendo, E.
, Pulakanti, K.
, Heimbruch, K.
, Stelloh, C.
, Chi, Y.
-Y.
, Sposto, R .
, Rao, S.
, Huynh, VT, Brown, P.
, Chang, BH, Colace, SI, Hermiston, ML, Heym, K.
, Hutchinson, RJ, Kaplan, JA, Mody, R.
, O'Brien, TA, Place, AE, Shaw, PH, Ziegler, DS, Wayne, A.
, Bhojwani, D.
and Burke, MJ (2022), Decitabine and Vorinostat with FLAG Chemotherapy in Pediatric Relapsed/Refractory AML: Report from the Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) Consortium.
Am J Hematol.
Accepted Author Manuscript.
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