ph-negative acute lymphoblastic leukemia
Conditions
Interventions
experimental group:The modified GRAALL-2003 protocol
Sponsors
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-45 years old, regardless of gender or race; 2. The patients who are in accordance with the diagnosis mode of MICM (morphology, immunology, cytogenetics and molecular); 3. Patients with Karnofsky score >= 60% and ECoG score 0-2; 4. In the first two weeks, the serum total bilirubin was less than 1.5 times of the upper limit of normal value (in the same age group); ALT and AST were less than 3 times of the upper limit of normal value (in the same age group); creatinine was less than 2 times of the upper limit of normal value (in the same age group); myocardial enzyme was less than 2 times of the upper limit of normal value (in the same age group); 5. Patients with negative anti HIV test; 6. Each subject must sign the informed consent form (ICF) to show that he / she understands the purpose and procedure of the study and is willing to participate in the study; considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the legal representative shall sign the ICF.
Exclusion criteria
Exclusion criteria: 1. Unresponsive or relapsed patients who have been treated with other schemes before; 2. Patients with Ph chromosome positive or BCR / abl fusion gene positive; 3. Patients with mixed cell leukemia; 4. Patients with severe organ dysfunction or disease, such as heart, liver, kidney, pancreas and other serious diseases and dysfunction; 5. Pregnant patients; 6. The researcher believes that it can damage the safety of the subjects and make the research results face unnecessary risks; 7. Patients with any life-threatening disease, physical condition or organ system dysfunction; drug addicts; subjects with uncontrolled mental disease; patients with cognitive dysfunction; 8. Patients who participated in other clinical studies in the past 3 months; 9. Patients that the researchers think are not suitable for the group (such as patients who are expected to be unable to adhere to the treatment due to funding and other issues).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First induction complete remission rate;Two-year survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Two-year relapse rate;adverse event; | — |
Countries
China
Contacts
Public ContactZhang Lei
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Outcome results
None listed