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NCT05382390

Dual Growth Factor (rhTPO + G-CSF) and Chemotherapy Combination Regimen in Acute Myeloid Leukemia: Study Protocol for a Randomized Controlled Trial

Status unknown Phase 3 Last updated 19 May 2022
What this trial tests

Phase 3 trial testing rhTPO in Acute Myeloid Leukemia in 130 participants. Status unknown.

Timeline
21 January 2022
Primary endpoint
21 January 2024
21 January 2026

Quick facts

Lead sponsorHuihan Wang
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment130
Start date21 January 2022
Primary completion21 January 2024
Estimated completion21 January 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Huihan Wang

Who can join

60 and older, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute myeloid leukemia (AML) is a disease affecting older adults, although optimal strategies for treating such patients remain unclear. This prospective phase II, openlabel, multicenter study was designed to assess the efficacy and safety of two hematologic growth factors, recombinant human thrombopoietin (rhTPO) and granulocyte colonystimulating factor (G-CSF), in combination with decitabine, cytarabine, and aclarubicin (D-CTAG regimen) to treat older adults with newly diagnosed AML (Identifier: NCT04168138). The above agents were administered as follows: decitabine (15 mg/m2 daily, days 1-5); low-dose cytarabine (10 mg/m2 q12 h, days 3-9); rhTPO (15,000U daily, days 2, 4, 6, 8, 10-24 or until \>50×109/L platelets); aclarubicin (14 mg/m2 daily, days 3-6); and G-CSF (300 μg daily, days 2-9). We concurrently monitored historic controls treated with decitabine followed by cytarabine, aclarubicin, and G-CSF (D-CAG) only. After the first D-CTAG cycle, the overall response rate (ORR) was 84.2% (16/19), including 13 (73.7%) complete remissions (CRs) and three (15.8%) partial remissions. This CR rate surpassed that of the D-CAG treatment (p \< 0.05). Median overall survival (OS) time in the D-CTAG group was 20.2 months (range, 4-31 months), compared with 14 months in the D-CAG group, and 1-year OS was 78%. The proportion of those experiencing grade III-IV thrombocytopenia was significantly lower for D-CTAG (57.9%) than for D-CAG (88.4%; p \< 0.05). Ultimately, the curative effect of adding rhTPO was not inferior to that of D-CAG, and D-CTAG proved safer for elderly patients, especially in terms of hematologic toxicity. A prospective phase III randomized study is warranted to confirm these observations.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Acute Myeloid Leukemia in Older Patients: From New Biological Insights to Targeted Therapies.
    Niscola P, Gianfelici V, Catalano G, Giovannini M, et al · · 2024 · cited 10× · PMID 39590121 · DOI 10.3390/curroncol31110490

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