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Association details:
Evidence:
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
10/14/2020
Excerpt:
Acute Myeloid Leukemia (Age ≥18 years): IDH1 of IDH2 mutation or FLT3 mutation…Venetoclax-based therapy with decitabine noted as preferred...
Secondary therapy:
decitabine
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
10/14/2020
Excerpt:
Acute Myeloid Leukemia (Age ≥18 years): IDH1 of IDH2 mutation or FLT3 mutation…Venetoclax-based therapy with azacitidine noted as category 1 and preferred...
Secondary therapy:
azacitidine
Evidence Level:
Sensitive: B - Late Trials
Title:

Impact of FLT3 mutation on outcomes after venetoclax and azacitidine for patients with treatment-naive acute myeloid leukemia

Published date:
01/21/2022
Excerpt:
In the biomarker evaluable population, FLT3 mutation was detected in 42 (15%) and 22 (19%) patients in the venetoclax+azacitidine and azacitidine groups. Composite complete remission (CRc, complete remission [CR]+CR with incomplete hematologic recovery [CRi]) rates (venetoclax+azacitidine /azacitidine) for FLT3 mutant patients were 67%/36%, median duration of remission (DoR) was 17.3/5.0 months, and median OS was 12.5/8.6 months. The CRc rates among FLT3 wild-type were 67%/25%, median DoR 18.4/13.4 months, and median OS 14.7/10.1 months. When treated with venetoclax+azacitidine, patients with FLT3 mutations and FLT3 wild-type had similar outcomes.
Secondary therapy:
azacitidine
DOI:
10.1158/1078-0432.CCR-21-3405
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF VENETOCLAX WITH AZACITIDINE VS AZACITIDINE IN TREATMENT-NAÏVE PATIENTS WITH ACUTE MYELOID LEUKEMIA INELIGIBLE FOR INTENSIVE THERAPY-VIALE-A

Published date:
06/14/2020
Excerpt:
Among treatment-naïve predominantly elderly pts with AML ineligible for intensive therapy, the combination regimen of AZA+VEN led to statistically significant and clinically meaningful improvement in response rates and OS as compared to AZA, with a manageable safety profile.
Secondary therapy:
azacitidine
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study aimed at evaluating the efficacy of the combination of the two drugs, Venetoclax and Azacitidine, on the treatment of patients suffering from Acute Myeloid Leukemia with NPM1 mutation. Studio volro a valutare l'efficacia della combinazione dei due farmaci, Venetoclax ed Azacitidina, sul trattamento di pazienti affetti da Leucemia Mieloide Acuta con mutazione di NPM1.

Excerpt:
...Pazienti che hanno ricevuto una precedente diagnosi di leucemia mieloide acuta con mutazione di NPM1 con o senza concomitante mutazione di FLT3-TKD o FLT3-ITD3. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia

Excerpt:
...a documented FMS-like Tyrosine Kinase (FLT3) mutation in bone marrow or peripheral blood, as described in the protocol....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Salvage Treatment With Venetoclax (Ven) and Hypomethylating Agents (HMA) for Relapsed/Refractory FLT3‑mutated Acute Myeloid Leukemia (AML) Patients: Clinical Characteristics and Outcomes

Published date:
09/01/2023
Excerpt:
Thirty FLT3m AML patients with R/R disease, treated at Mayo Clinic with HMA+Ven (with/without gilteritinib [Gilt]) between 2019 and 2022, were analyzed….Univariate analysis for OS showed a significantly better OS with FLT3m ITD subtype (P<0.0001), FLT3 allelic ratio <0.5 (P=0.03), and TET2 mutation (P=0.007)….Hypomethylating agent plus Ven based combination seem to be effective as salvage therapy in patients with FLT3m AML.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Sequential Venetoclax and FLT3 Inhibitors in Combination With Hypomethylating Agents or Low-Dose Chemotherapy in Newly Diagnosed, Unfit, FLT3-Mutant Acute Myeloid Leukemia Patients

Published date:
09/21/2022
Excerpt:
All patients achieved complete remission on day 21 and day 28….The sequential use of venetoclax followed by midostaurin in combination with low dose chemotherapy or HMA for newly diagnosed AML, FLT3-mutant patients who are unfit for intensive chemotherapy seems to be a promising approach with an acceptable toxicity profile.
Secondary therapy:
midostaurin
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Phase II Trial of Ten-Day Decitabine with Venetoclax (DEC10-VEN) in Acute Myeloid Leukemia: Updated Outcomes in Genomic Subgroups

Published date:
11/04/2021
Excerpt:
Pts received decitabine 20 mg/m2 on D1-10 until CR/CRi, followed by 5-day cycles. VEN dose was 400 mg daily but held on C1D21 if D21 bone marrow (BM) had ≤5% blasts….DEC10-VEN offered high rates of CR/CRi, negative MRD, favorable OS and RFS across several genomic subgroups of treatment-naïve AML including NPM1, FLT3, IDH1/2...
Secondary therapy:
decitabine
DOI:
10.1182/blood-2021-153227
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Safety and Efficacy: Clinical Experience of Venetoclax in Combination With Hypomethylating Agents in Both Newly Diagnosed and Relapsed/Refractory Advanced Myeloid Malignancies

Published date:
03/09/2021
Excerpt:
CONTRADICTED EVIDENCE: Of 26 newly diagnosed AML patients, the CR/CRi rate was 53.8%. The median DOR and OS were 6.9 months and not reached, respectively. Of 39 R/R AML patients, the CR/CRi rate was 38.5%. The median DOR and OS were both 8.1 months. Responders to HMA and venetoclax were enriched for TET2, IDH1, and IDH2 mutations, while nonresponders were associated with FLT3 and RAS mutations.
DOI:
10.1097/HS9.0000000000000549
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

996 Factors Associated with Clinical Outcomes after Venetoclax-Based Combination Therapy in Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms

Published date:
11/04/2020
Excerpt:
Ven was given in combination with HMA, low dose cytarabine (LDAC), or IC in 35 (83.3%), 6 (14.3%), and 1 (2.4%) pt respectively....CR/CRi rates were higher for pts with FLT3 (p=.040) and NPM1 mutations (p=.04).
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

1904 Results of Venetoclax and Azacitidine Combination in Chemotherapy Ineligible Untreated Patients with Acute Myeloid Leukemia with FLT3 Mutations

Published date:
11/04/2020
Excerpt:
Complete response (CR)+CR with partial hematologic recovery (CRh) rates in FLT3mut pts (Ven+Aza/Pbo+Aza) were 65% (95% CI:48%-79%)/18% (5%-40%)...Among pts with FLT3-ITD, CR+CRh rates (Ven+Aza/Pbo+Aza) were 61% (95% CI: 41%-79%)/23% (5%-54%)...CR+CRh rates in pts with FLT3-TKD were 69% (95% CI: 39%-91%)/20% (3%-56%) with mDoR 18.3 (95% CI: 3.0-NR)/NR (15.1-NR) mos.
Secondary therapy:
azacitidine
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Clinical Outcomes of Acute Myeloid Leukemia Patients Bridged to Allogeneic Stem Cell Transplant By Venetoclax Combination Therapy

Published date:
11/04/2020
Excerpt:
All AML pts who received treatment with aza/ven, dec/ven or LDAC/ven as either initial induction or for RR disease...A total of 130 pts were treated with ven combo therapy with 18 pts (13.8% of all pts) receiving a subsequent alloSCT. While pts with DNMT3A, NPM1, IDH1/2 and FLT3 mutations had a high response rate to ven therapy...Only DNMT3A mutations were statistically significantly associated with a high response rate prior to alloSCT (ORR 100%, CR/CRi 63%, p=0.01).
Secondary therapy:
cytarabine; azacitidine; decitabine
DOI:
10.1182/blood-2020-137749
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Venetoclax and hypomethylating agents in FLT3 -mutated acute myeloid leukemia

Published date:
07/06/2020
Excerpt:
The overall CR/CRi rate with VEN‐HMA was 60% (94% in treatment‐naïve AML and 42% in r/r AML)….VEN‐HMA is associated with encouraging efficacy in FLT3m AML among both newly diagnosed unfit and r/r patients.
Secondary therapy:
Hypomethylating agent
DOI:
https://doi.org/10.1002/ajh.25929
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Venetoclax in Combination with High-Dose Chemotherapy Is Active and Well-Tolerated in Children with Relapsed or Refractory Acute Myeloid Leukemia

Published date:
11/06/2019
Excerpt:
VEN combined with high-dose cytarabine or high-dose cytarabine and idarubicin was well tolerated and effective in children and young adults with relapsed or refractory AML. Enrollment continues to refine estimates of response rate. VEN window response is associated with BH3 dependence and end of cycle 1 response rates. Targeting BCL-XL or FLT3 may improve response to combination therapy...
Secondary therapy:
cytarabine; cytarabine
DOI:
https://doi.org/10.1182/blood-2019-127716
Evidence Level:
Sensitive: C3 – Early Trials
New
Source:
Title:

Response to Venetoclax in Combination with Low Intensity Therapy (LDAC or HMA) in Untreated Patients with Acute Myeloid Leukemia Patients with IDH, FLT3 and Other Mutations and Correlations with BCL2 Family Expression

Excerpt:
The CR/CRi rates were 83.7% for pts with IDH1/IDH2 mutations, 84.6% for pts with NPM1 mutations, 59.5% for pts with TP53 mutations, and 53.3% for pts with FLT3 mutations (Table 2)….VEN + HMA or LDAC has efficacy across multiple molecular markers in AML
Secondary therapy:
cytarabine
DOI:
https://doi.org/10.1182/blood-2019-128373