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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vincristine | Drug | acute lymphoblastic leukemia (ALL) -based chemotherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | From the date of diagnosis until the date of death from any cause, | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse free survival (RFS) | From the date of CR until the date of relapse or death | up to 5 years |
| The complete remission (CR) rate | Incidence of complete remission after induction chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Chromosomal abnormalities detected by G-banding | Baseline | |
| Fusion genes detected by polymerase chain reaction | Baseline | |
| Mutations detected by next-generation sequencing |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianxiang Wang, Dr | Contact | 86-22-23909120 | wangjx@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HBDH | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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| daunorubicin |
| Drug |
acute lymphoblastic leukemia (ALL) -based chemotherapy |
|
| cyclophosphamide | Drug | acute lymphoblastic leukemia (ALL) -based chemotherapy |
|
| L-Asparaginase | Drug | acute lymphoblastic leukemia (ALL) -based chemotherapy |
|
| prednisone | Drug | acute lymphoblastic leukemia (ALL) -based chemotherapy |
|
| mercaptopurine | Drug | acute lymphoblastic leukemia (ALL) -based chemotherapy |
|
| methotrexate | Drug | acute lymphoblastic leukemia (ALL) -based chemotherapy |
|
| dexamethasone | Drug | acute lymphoblastic leukemia (ALL) -based chemotherapy |
|
| Tyrosine kinase inhibitor | Drug | acute lymphoblastic leukemia (ALL) -based chemotherapy |
|
| up to 2.5 years |
| Mortality within 60 days | Proportion of patients died within 60 days | up to 60 days |
| Baseline |
| Minimal residual disease(MRD) | The presence of small numbers of leukemic cells detected by the flow cytometry after remission | 1 year |
| ID | Term |
|---|---|
| D015456 | Leukemia, Biphenotypic, Acute |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D014750 | Vincristine |
| D003630 | Daunorubicin |
| D003520 | Cyclophosphamide |
| D001215 | Asparaginase |
| D011241 | Prednisone |
| D015122 | Mercaptopurine |
| D008727 | Methotrexate |
| D003907 | Dexamethasone |
| D000092004 | Tyrosine Kinase Inhibitors |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D011687 | Purines |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D011246 | Pregnadienetriols |
| D013259 | Steroids, Fluorinated |
| D047428 | Protein Kinase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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