Study of Decitabine Combined With HAAG Regimen in Newly Diagnosed ETP-ALL/LBL, T/M-MPAL and ALL/LBL With Myeloid or Stem Cell Markers Patients

Induction Chemotherapy Clinical Trial

Official title:

A Phase 3, Open Label, Single Arm, Multi-Center Study to Evaluate the Efficacy and Safety of Decitabine Combined With HAAG Regimen in Newly Diagnosed ETP-ALL/LBL, T/M-MPAL and ALL/LBL With Myeloid or Stem Cell Markers Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04446130
• Other study ID #: DAC-HAAG-03
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2019
• Est. completion date: January 1, 2024

Study information

• Verified date: June 2020
• Source: The First Affiliated Hospital of Soochow University
• Contact: Xiaowen Tang, Ph.D.
• Phone: (0086)51267781856
• Email: xwtang1020[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of decitabine combined with HAAG regimen in the treatment of newly diagnosed patients with ETP-ALL/LBL, T/M-MPAL and ALL/LBL with myeloid or stem cell markers.

Description:

This is a phase 3, open label, single arm, multi-center study in newly diagnosed ETP-ALL/LBL, T/M-MPAL and ALL/LBL patients who have myeloid or stem cell markers. The patients will receive decitabine combined with HAAG regimen in the induction treatment. The patients who respond to induction chemotherapy will undergo consolidation chemotherapy, and an optional allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment with decitabine according to patient's wishes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Newly diagnosed ETP-ALL/LBL, T/M-MPAL according to the 2016 revision to the WHO classification of myeloid neoplasms and acute leukemia, and T-ALL/LBL with one or more of the myeloid or stem cell markers (CD34, CD117, HLADR, CD13, CD33, CD11b or CD65) on at least 25% of lymphoblasts.

2. Age 15-60.

3. Eastern Cooperative Oncology Group (ECOG) score: 0-2.

4. No history of previous chemotherapy or target therapy.

5. Provide informed consent.

Exclusion Criteria:

1. Patients with another malignant disease.

2. Patients has participated in or participating in other clinical trials.

3. Patients with uncontrolled active infection.

4. Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.

5. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL.

6. Patients with creatinine clearance rate < 50ml/min.

7. Patients with active hepatitis B or hepatitis C infection.

8. Patients with HIV infection.

9. Patients with active tuberculosis infection.

10. Patients with uncontrolled active bleeding.

11. Patients with a history of allergy to experimental drugs.

12. Patients with other commodities that the investigators considered not suitable for the enrollment.

Related Conditions & MeSH terms

• Acute T-Lymphocytic Leukemia
• Induction Chemotherapy
• Leukemia
• Leukemia, T-Cell
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
• T-cell Lymphoblastic Lymphoma Leukemia
• T-cell/Myeloid Mixed Phenotype Acute Leukemia

Intervention

Drug:
• Decitabine combined with HAAG Regimen
Decitabine :20mg/m2/d,d1~5, intravenous infusion; Homoharringtonine :1mg/d,d3~16,intravenous infusion; Aclarubicin :10mg/d, d3~d10, intravenous infusion; Cytarabine :10mg/m2,q12h,d3-16, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300µg/d (when WBC counts are less than 20×10^9/L ),subcutaneous injection

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (8)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University	Changzhou No.2 People's Hospital, Henan Cancer Hospital, Shandong Provincial Hospital, Shenzhen People's Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Anhui Medical University, The Second People's Hospital of Huai'an

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	ORR includes complete remission (CR), CR with incomplete hematologic recovery (CRi) and partial remission (PR). CR was defined as < 5% bone marrow blasts in an aspirate with spicules and independent of transfusions; CRi: was defined as<5% bone marrow blasts, either ANC<1×10^9/L or platelets<100×10^9/L, transfusion independence but with persistence of cytopenia; PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts.	Day 28-35 of induction course
Secondary	Overall survival (OS)	time from randomization to death from any cause	4 years
Secondary	Leukemia-free survival (LFS)	time from randomization to the first relapse or death	4 years
Secondary	Cumulative incidence of relapse(CIR)	time from achievement of a remmission to the first relapse	4 years
Secondary	Number of adverse events	adverse events are evaluated with CTCAE V5.0.	3 years