Induction ChemotherapyPhase 3NCT04446130
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
A Phase 3 study testing Decitabine combined with HAAG Regimen in people with Induction Chemotherapy and Acute T-Lymphocytic Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Induction Chemotherapy, Acute T-Lymphocytic Leukemia, T-cell Lymphoblastic Lymphoma Leukemia
- What is being tested?
- Decitabine combined with HAAG Regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- Age 15-60.
- Eastern Cooperative Oncology Group (ECOG) score: 0-2.
- No history of previous chemotherapy or target therapy.
- Provide informed consent.
Who cannot join
- Patients with another malignant disease.
- Patients has participated in or participating in other clinical trials.
- Patients with uncontrolled active infection.
- Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
- Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL.
- Patients with creatinine clearance rate < 50ml/min.
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- Patients with active hepatitis B or hepatitis C infection.
- Patients with HIV infection.
- Patients with active tuberculosis infection.
- Patients with uncontrolled active bleeding.
- Patients with a history of allergy to experimental drugs.
- Patients with other commodities that the investigators considered not suitable for the enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Xiaowen Tang, Ph.D, (0086)51267781856, xwtang1020@163.com
About this study
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
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.
Read the detailed 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.
- Conditions
- Induction Chemotherapy, Acute T-Lymphocytic Leukemia, T-cell Lymphoblastic Lymphoma Leukemia, T-cell/Myeloid Mixed Phenotype Acute Leukemia
- Being tested
- Decitabine combined with HAAG Regimen
- Keywords
- T-ALL/LBL, T/M-MPAL, Decitabine combined with HAAG
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decitabine combined with HAAG RegimenDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Decitabine combined with HAAG Regimen | Experimental | This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed T-ALL/LBL and T/M-MPAL patients. Receives: Drug: Decitabine combined with HAAG Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28-35 of induction course
Secondary outcomes (4)
Overall survival (OS)
time from randomization to death from any cause
Measured: 4 years
Leukemia-free survival (LFS)
time from randomization to the first relapse or death
Measured: 4 years
Cumulative incidence of relapse(CIR)
time from achievement of a remmission to the first relapse
Measured: 4 years
Number of adverse events
adverse events are evaluated with CTCAE V5.0.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Jan 2019
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction ChemotherapyStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Cancer Hospital, Shandong Provincial Hospital, Shenzhen People's Hospital, The First Affiliated Hospital of Anhui Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Changzhou No.2 People's Hospital, The Second People's Hospital of Huai'an
- Responsible party
- Sponsor
- Investigators
- Xiaowen Tang, Ph.D., Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446130
- Sponsor's protocol ID
- DAC-HAAG-03
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 24 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04446130
- Acronym / sponsor ID
- DAC-HAAG-03
- Conditions
- Induction Chemotherapy, Acute T-Lymphocytic Leukemia, T-cell Lymphoblastic Lymphoma Leukemia, T-cell/Myeloid Mixed Phenotype Acute Leukemia
- Keywords
- T-ALL/LBL, T/M-MPAL, Decitabine combined with HAAG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Henan Cancer Hospital, Shandong Provincial Hospital, Shenzhen People's Hospital, The First Affiliated Hospital of Anhui Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Changzhou No.2 People's Hospital, The Second People's Hospital of Huai'an
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 24 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decitabine combined with HAAG Regimen | Experimental | Drug: Decitabine combined with HAAG RegimenThis cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed T-ALL/LBL and T/M-MPAL patients. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
- Age 15-60.
- Eastern Cooperative Oncology Group (ECOG) score: 0-2.
- No history of previous chemotherapy or target therapy.
- Provide informed consent.
Key exclusion criteria (12 listed)
- Patients with another malignant disease.
- Patients has participated in or participating in other clinical trials.
- Patients with uncontrolled active infection.
- Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
- Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decitabine combined with HAAG RegimenDecitabine :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 | Drug | Decitabine combined with HAAG Regimen |
Primary outcome
Overall Response Rate (ORR)
Time frame: Day 28-35 of induction course
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.
4 secondary outcomes
Overall survival (OS)
Time frame: 4 years
Leukemia-free survival (LFS)
Time frame: 4 years
Cumulative incidence of relapse(CIR)
Time frame: 4 years
Number of adverse events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaowen Tang, Ph.D. principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Decitabine combined with HAAG Regimen in people with Induction Chemotherapy and Acute T-Lymphocytic Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaowen Tang, Ph.D. ((0086)51267781856, xwtang1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Day 28-35 of induction course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.