Adult Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Comparison of Remission Rate and Leukemic Stem Cell Changes Among Patients With Newly Diagnosed Adult ALL With Liposomal Doxorubicin and Daunorubicin-containing VDCLD Regimen.
This trial is a multicenter prospective, open, non-intervention clinical study. 200 patients with newly diagnosed adult ALL who underwent induction remission with the VDCLD regimen containing PLD and DNR, respectively,were plan to enrolled in this study to evaluate the CR rate and the level of myeloid leukemia stem cells in the first course of chemotherapy with two regimens; and to evaluate the safety of the two induction chemotherapy regimens.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 30, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 1.Male or female, age:14-60 years old; 2.ECOG score 0-2; 3.Subjects had confirmed ALL (WHO classification, primitive cells = 20%); 4.Patients with newly diagnosed ALL who have not previously received chemotherapy (except for dexamethasone, prednisone, hydroxyurea).Blood transfusion, use of hematopoietic growth factors or vitamins are allowed. Some temporary measures such as leukocyte removal, dexamethasone, prednisone, hydroxyurea (0.5-3g daily, over 3 days) are allowed; 5.Flow cytometry was used to detect leukemic stem cells in bone marrow samples before treatment; 6.Informed consent (all studies must be signed patient informed consent). Exclusion Criteria: - 1.Mixed AL patients; 2.Active systemic infection; 3.Lactating women, fertile women with positive pregnancy tests for urine or pregnant women who are unwilling to adopt appropriate methods of contraception (such as the use of birth control pills, intrauterine devices, diaphragms, abstinence, condom use) during the study ; 4. Patients currently have a history of cardiac insufficiency (especially congestive heart failure) or previous history of congestive heart failure; 5. Patients with severe liver failure (=5 times upper limit of normal transaminase, total bilirubin =3 mg/dL); 6. Patients had renal insufficiency with creatinine clearance <30 ml/min and creatinine clearance calculated as follows: Male: Ccr (ml / min) = (140-age) × body weight (kg) / [0.8136 × serum creatinine (µmol/L)] women: Ccr (ml/min) = (140-age) × body weight (kg) × 0.85 / [0.8136 × serum creatinine (µmol/L)]; 7. Patient is involved in other drugs experimental study within 30 days prior to the trial or within 90 days of the start of the trial; 8. Researchers think it is not suitable for enrolling. |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Hospital of Guangdong Medical University | Guangdong | Guangdong |
Lead Sponsor | Collaborator |
---|---|
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CR | complete remission after the first course treatment of induced remission chemotherapy | From date of randomization until the date of first course of chemotherapy treatment completed, assessed up to 4 weeks. | |
Secondary | changes of myeloid leukemia stem cells | to evaluate the changes of myeloid leukemia stem cells in patients before and after induction of VDCLD with PLD and DNR respectively. | From date of randomization until the date of first course of chemotherapy treatment completed, assessed up to 4 weeks. |
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