Patients with biphenotypic acute leukemia and subjects with normal bone marrow
Conditions
Interventions
BAL group vs normal bone marrow group:Nil
Sponsors
Beijing Tsinghua Changgung Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria of subjects with normal bone marrow: 1) The subjects aged 18 to 30 years; 2) Fever symptoms were found in 6 months, and the cause is needed to be confirmed; 3) The bone marrow is normal and health through bone marrow morphological detection; 4) The body weight >=45 kg, and the body mass index is between 18 and 28 kg / m2 (including boundary value), BMI = body weight (kg) / height (m) 2; 5) Subjects agree to take effective physical contraception measures from 2 weeks before enrollment to the end of follow-up period; 6) The female subjects are not in pregnancy or lactation; 7) The results of tests including vital signs, 12 lead ECG, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen and kidney), clinical laboratory tests (coagulation function, blood biochemistry, blood routine, urine routine, blood pregnancy, etc.) were not abnormal or slightly abnormal, but were not clinically significant judged by investigator; 8)Voluntarily participate in this clinical trial, understand the research procedures and can sign informed consent in writing. Inclusion criteria of BAL patients: 1) Patients aged 18-55 years (including 18 and 55 years old) with dualphenotype acute leukemia; 2) Weight >= 45 kg; 3) The results of tests including vital signs, 12 lead ECG, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen and kidney), clinical laboratory tests (coagulation function, blood biochemistry, urine routine, blood pregnancy, etc.) were not abnormal or slightly abnormal, but were not clinically significant judged by investigator; 4) Voluntarily participated in the clinical trial, understand the research procedures and can sign the informed consent in writing.
Exclusion criteria
Exclusion criteria: The exclusion criteria of subjects with normal bone marrow: 1) Subjects with the history of hypothalamus or pituitary diseases which was clinically significant diagnosed by investigator, and subjects with the history of thrombosis or have the thrombotic diseases in present; 2) Subjects who have used any prescription medicine or therapeutic drugs within one week before operation; 3) Subjects who drank alcohol frequently within 6 months before screening, those who drank alcohol 24 hours before bone marrow puncture, or whose result of alcohol breath test is greater than 0.0 mg / 100 ml; 4) Drug abusers (e.g. morphine, methamphetamine, ketamine, MDMA, THC, cocaine, etc.) or subjects whose drug screening test is positive; 5) Subjects who received blood transfusion or used blood products within 3 months; 6) Subjects who are allergic to lidocaine or other narcotic drugs; 7) Patients with blood-related hemorrhagic disease; 8) Subjects with abnormal blood glucose; 9) Any of the results of novel coronavirus, HAV, HBV, HCV, HIV, HSV- I, HSV- II, EBV, CMV, HTLV- I, HTLV- II and syphilis is positive. 10) Subjects who have participated in other clinical trial within one month, or who have received the study drug but is not more than 5 half-lives, or who plan to participate in other trials at any time during this trial period; 11) The investigator thinks who is not suitable for enrollment. Exclusion criteria of BAL patients: 1) Drug abusers (e.g. morphine, methamphetamine, ketamine, MDMA, THC, cocaine, etc.) or subjects whose drug screening test is positive; 2) Subjects who are allergic to lidocaine or other narcotic drugs; 3) Patients with blood-related hemorrhagic disease; 4) Diabetics; 5) Any of the results of novel coronavirus, HAV, HBV, HCV, HIV, HSV- I, HSV- II, EBV, CMV, HTLV- I, HTLV- II and syphilis is positive . 6) Subjects who have participated in other clinical trial within one month; 7) The investigater think who is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum immunological test;Serum pathogenic microbiology test;flow cytometry test;Next Generation sequencing;bone marrow cell morphology test;giemsa-banding; | — |
Countries
China
Contacts
Public ContactHongli Li
BeijingTsinghua Changgung Hospital
Outcome results
None listed