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

NCT05382390 | Unknown Phase 3 DMC

• 1 other identifier: hhhWang
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• overall survival (OS)

  overall survival

  2 years after the end of treatment of the last patient enrolled

Study Arms (2)

lderly Patients With Acute Myeloid Leukemia DCTAG

EXPERIMENTAL

decitabine (15 mg/m2 daily, days 1-5); low-dose cytarabine (10 mg/m2 q12 h, days 3-9); rhTPO (15,000 U daily, days 2, 4, 6, 8, and 10-24 or until a platelet count \> 50 × 109/L was observed); aclarubicin (14 mg/m2 daily, days 3-6); and G-CSF (300 μg daily, days 2-9).

Drug: rhTPO; Drug: Decitabine

lderly Patients With Acute Myeloid Leukemia

OTHER

decitabine (15 mg/m2 daily, days 1-5); low-dose cytarabine (10 mg/m2 q12 h, days 3-9); aclarubicin (14 mg/m2 daily, days 3-6); and G-CSF (300 μg daily, days 2-9).

Drug: Decitabine

Interventions

rhTPO DRUG

decitabine (15 mg/m2 daily, days 1-5); low-dose cytarabine (10 mg/m2 q12 h, days 3-9); rhTPO (15,000 U daily, days 2, 4, 6, 8, and 10-24 or until a platelet count \> 50 × 109/L was observed); aclarubicin (14 mg/m2 daily, days 3-6); and G-CSF (300 μg daily, days 2-9).

Also known as: Decitabine, Aclarubicin, G-CSF, Cytarabine

lderly Patients With Acute Myeloid Leukemia DCTAG

Decitabine DRUG

decitabine (15 mg/m2 daily, days 1-5); low-dose cytarabine (10 mg/m2 q12 h, days 3-9); aclarubicin (14 mg/m2 daily, days 3-6); and G-CSF (300 μg daily, days 2-9).

Also known as: Aclarubicin, G-CSF, Cytarabine

lderly Patients With Acute Myeloid Leukemia; lderly Patients With Acute Myeloid Leukemia DCTAG

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 or above, male or female; Acute Myeloid Leukemia (non-M3) diagnosed according to the 2008 World Health Organization (WHO) diagnostic criteria for myeloid malignancies; Newly diagnosed, no treatment for anti-leukemia; The Eastern Cooperative Oncology Group（ECOG） status score is 0 to 3 points; Expected survival time ≥ 3 months; No serious heart, lung, liver or kidney disease; History of no thromboembolism Ability to understand and be willing to sign the informed consent form of this trial.

You may not qualify if:

• used to be allergic to the drugs contained in the protocol or to drugs similar in chemical structure to the test drugs; serious active infections; Patients with extramedullary lesions; Patients who use drugs and long-term alcohol abuse to influence the evaluation of test results; Inability to obtain informed consent and cannot complete the trial treatment and examination procedures because of mental illness or other conditions Patients with clinically significant corrected QT interval (QTc) prolongation (male \> 450ms, female \> 470ms), Ventricular Tachycardia (VT), Atrial Fibrillation (AF), grade II or higher heart block, Myocardial Infarction (MI) within 1 year, Congestive Heart Failure (CHF), coronary heart disease with symptoms who need medical treatment; Abnormal liver function (total bilirubin \> 1.5 times the upper limit of normal value, Alanine aminotransferase(ALT) / Aspartate aminotransferase (AST) \>2.5 times the upper limit of normal value or ALT / AST in patients with liver invasion \> 5 times the upper limit of normal value of normal), abnormal renal function (serum Creatinine \> 1.5 times the upper limit of normal); The investigator determine that the participants are not suitable

Sponsors & Collaborators

• Huihan Wang: lead

Study Sites (1)

ShengJing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Decitabine; Aclarubicin; Granulocyte Colony-Stimulating Factor; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Arabinonucleosides

Central Study Contacts

Huihan Wang, Doctor

CONTACT

+86 18940256966; wanghh24115@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To compensate for the need for an open-label design, the primary outcome data are collected with blinding. The staff responsible for data monitoring and statistician will also be blinded to the treatment groups until the statistical analysis was finalized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: January 21, 2022
• Primary Completion: January 21, 2024
• Study Completion: January 21, 2026
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)