Acute Leukemia of Ambiguous LineagePhase 2NCT04440267
Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage
A Phase 2 study testing vincristine, daunorubicin and cyclophosphamide in people with Acute Leukemia of Ambiguous Lineage, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
In this prospective, single arm, open label, clinical trial, a total of 50 acute leukemia of ambiguous lineage patients will be enrolled. Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) after CR . Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Acute Leukemia of Ambiguous Lineage
- What is being tested?
- vincristine, daunorubicin and cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2020to 20 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged above 14 years with acute leukemia of ambiguous lineage .
- Eastern Cooperative Oncology Group (ECOG) Performance status 2.
- Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); serum glutamic-oxaloacetic transaminase(SGOT) and serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; Patients must have adequate cardiac function (ejection fraction ≥ 45 % on Multiple Gated Acquisition (MUGA) scan).
- Patients must have the following laboratory values (≥ lower limit of normal (LLN) or corrected to within normal limits with supplements prior to the first dose of study medication.): Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN
- Patients should sign informed consent form.
Who cannot join
- Impaired cardiac function:
- Long QT syndrome or a known family history of long QT syndrome; clinically significant resting brachycardia (<50 beats per minute); ejection fraction < 45 % on MUGA scan. Corrected QT (QTc) interval > 450 msec on baseline ECG (using the QTcF formula). If QTcF interval>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc. Myocardial infarction within 12 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).
- Other concurrent severe and/or uncontrolled medical conditions:
- Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.
- Patients who are: (a) pregnant and (b) breast feeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
HBDH
Tianjin, Tianjin Municipality, 300020
Hui Wei
About this study
Official title: A Prospective, Single Arm, Open Label, Clinical Trial to Evaluate the Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage
In this prospective, single arm, open label, clinical trial, a total of 50 acute leukemia of ambiguous lineage patients will be enrolled. Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) after CR . Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors. The purpose of current study is to evaluate the clinical efficacy of ALL-based chemotherapy，effect of genetic abnormality and minimal residual disease (MRD) on prognosis in patients with acute leukemia of ambiguous lineage.
- Conditions
- Acute Leukemia of Ambiguous Lineage
- Being tested
- vincristine, daunorubicin, cyclophosphamide, L-Asparaginase, prednisone
- Medical subject headings
- Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vincristineDrug
acute lymphoblastic leukemia (ALL) -based chemotherapy
daunorubicinDrug
acute lymphoblastic leukemia (ALL) -based chemotherapy
cyclophosphamideDrug
acute lymphoblastic leukemia (ALL) -based chemotherapy
L-AsparaginaseDrug
acute lymphoblastic leukemia (ALL) -based chemotherapy
prednisoneDrug
acute lymphoblastic leukemia (ALL) -based chemotherapy
mercaptopurineDrug
acute lymphoblastic leukemia (ALL) -based chemotherapy
methotrexateDrug
acute lymphoblastic leukemia (ALL) -based chemotherapy
dexamethasoneDrug
acute lymphoblastic leukemia (ALL) -based chemotherapy
Tyrosine kinase inhibitorDrug
acute lymphoblastic leukemia (ALL) -based chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) in CR. Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors. Receives: Drug: vincristine; Drug: daunorubicin; Drug: cyclophosphamide; Drug: L-Asparaginase; Drug: prednisone; Drug: mercaptopurine; Drug: methotrexate; Drug: dexamethasone; Drug: Tyrosine kinase inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
From the date of diagnosis until the date of death from any cause,
Measured: up to 5 years
Secondary outcomes (3)
Relapse free survival (RFS)
From the date of CR until the date of relapse or death
Measured: up to 5 years
The complete remission (CR) rate
Incidence of complete remission after induction chemotherapy
Measured: up to 2.5 years
Mortality within 60 days
Proportion of patients died within 60 days
Measured: up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start8 Jul 2020
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Leukemia of Ambiguous LineageStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440267
- Sponsor's protocol ID
- IIT2020009
- Status last verified
- Aug 2025
- First submitted
- 11 Jun 2020
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Open Label, Clinical Trial to Evaluate the Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage
- ClinicalTrials.gov ID
- NCT04440267
- Acronym / sponsor ID
- IIT2020009
- Conditions
- Acute Leukemia of Ambiguous Lineage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 19 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.
In this prospective, single arm, open label, clinical trial, a total of 50 acute leukemia of ambiguous lineage patients will be enrolled. Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) after CR . Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors. The purpose of current study is to evaluate the clinical efficacy of ALL-based chemotherapy，effect of genetic abnormality and minimal residual disease (MRD) on prognosis in patients with acute leukemia of ambiguous lineage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: vincristine, Drug: daunorubicin, Drug: cyclophosphamide, Drug: L-Asparaginase, Drug: prednisone, Drug: mercaptopurine, Drug: methotrexate, Drug: dexamethasone, Drug: Tyrosine kinase inhibitorPatients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) in CR. Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged above 14 years with acute leukemia of ambiguous lineage .
- Eastern Cooperative Oncology Group (ECOG) Performance status 2.
- Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); serum glutamic-oxaloacetic transaminase(SGOT) and serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; Patients must have adequate cardiac function (ejection fraction ≥ 45 % on Multiple Gated Acquisition (MUGA) scan).
- Patients must have the following laboratory values (≥ lower limit of normal (LLN) or corrected to within normal limits with supplements prior to the first dose of study medication.): Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN
- Patients should sign informed consent form.
Key exclusion criteria (5 listed)
- Impaired cardiac function:
- Long QT syndrome or a known family history of long QT syndrome; clinically significant resting brachycardia (<50 beats per minute); ejection fraction < 45 % on MUGA scan. Corrected QT (QTc) interval > 450 msec on baseline ECG (using the QTcF formula). If QTcF interval>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc. Myocardial infarction within 12 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).
- Other concurrent severe and/or uncontrolled medical conditions:
- Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.
- Patients who are: (a) pregnant and (b) breast feeding.
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 |
|---|---|---|
| vincristineacute lymphoblastic leukemia (ALL) -based chemotherapy | Drug | single arm |
| daunorubicinacute lymphoblastic leukemia (ALL) -based chemotherapy | Drug | single arm |
| cyclophosphamideacute lymphoblastic leukemia (ALL) -based chemotherapy | Drug | single arm |
| L-Asparaginaseacute lymphoblastic leukemia (ALL) -based chemotherapy | Drug | single arm |
| prednisoneacute lymphoblastic leukemia (ALL) -based chemotherapy | Drug | single arm |
| mercaptopurineacute lymphoblastic leukemia (ALL) -based chemotherapy | Drug | single arm |
| methotrexateacute lymphoblastic leukemia (ALL) -based chemotherapy | Drug | single arm |
| dexamethasoneacute lymphoblastic leukemia (ALL) -based chemotherapy | Drug | single arm |
| Tyrosine kinase inhibitoracute lymphoblastic leukemia (ALL) -based chemotherapy | Drug | single arm |
Primary outcome
Overall survival (OS)
Time frame: up to 5 years
From the date of diagnosis until the date of death from any cause,
3 secondary outcomes
Relapse free survival (RFS)
Time frame: up to 5 years
The complete remission (CR) rate
Time frame: up to 2.5 years
Mortality within 60 days
Time frame: up to 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vincristine, daunorubicin and cyclophosphamide in people with Acute Leukemia of Ambiguous Lineage, run by Institute of Hematology & Blood Diseases Hospital, China 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 5 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: looking for participants now, as of the sponsor's last update on 6 Aug 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianxiang Wang, Dr (86-22-23909120, wangjx@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: up to 5 years). 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 6 Aug 2025.