- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03419494
Comparison of Liposomal Doxorubicin and Daunorubicin-containing VDCLD Regimen in the Treatment of Adult ALL Patients
Comparison of Remission Rate and Leukemic Stem Cell Changes Among Patients With Newly Diagnosed Adult ALL With Liposomal Doxorubicin and Daunorubicin-containing VDCLD Regimen.
Study Overview
Status
Conditions
Detailed Description
Subjects will receive one of two treatment regimens:
Group A: intravenous drip of liposomal doxorubicin 36 mg/m2, d1、d15,1h; VCR 1.4mg/m2.d d1,d8,d15,d22 iv,CTX 800mg/m2.d d1 ivdrip,L-asp 6000u/m2.d d19~28 ivdrip,Dex10mg.d d1~28 ivdrip,once every 28days.
Group B: intravenous drip of DNR45mg/m2,d d1~3,1h;VCR 1.4mg/m2.d d1,d8,d15,d22 iv,CTX 800mg/m2.d d1 ivdrip,L-asp 6000u/m2.d d19~28 ivdrip,Dex10mg.d d1~28 ivdrip,once every 28days. The primary endpoint is complete remission after the first course treatment of induced remission chemotherapy, to evaluated the ratio of CR patients after the first course of chemotherapy with PLD and DNR VDCLD regimens.The secondary endpoint is to evaluate the changes of myeloid leukemia stem cells in patients before and after induction of VDCLD with PLD and DNR respectively.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Guangdong
-
Guangdong, Guangdong, China, 524001
- Recruiting
- Affiliated Hospital of Guangdong Medical University
-
Contact:
- honghua he, doctor
- Phone Number: 13828229695
- Email: 192880@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
VDCLD regimen containing PLD
PLD 36mg/㎡.d
d1、d15,ivdrip,1h,VCR 1.4mg/㎡.d
d1,d8,d15,d22 iv,CTX 800mg/㎡.d
d1 ivdrip,L-asp 6000u/㎡.d
d19~28 ivdrip,Dex10mg.d
d1~28 ivdrip
|
PLD36mg/m2.d d1、d15,ivdrip,1h,VCR 1.4mg/m2.d
d1,d8,d15,d22 iv,CTX 800mg/m2.d
d1 ivdrip,L-asp 6000u/m2.d
d19~28 ivdrip,Dex10mg.d
d1~28 ivdrip
Other Names:
|
VDCLD regimen containing DNR
DNR 45mg/㎡.d
d1~3,ivdrip,1h,VCR 1.4mg/㎡.d
d1,d8,d15,d22 iv,CTX 800mg/㎡.d
d1 ivdrip,L-asp 6000u/㎡.d
d19~28 ivdrip,Dex10mg.d
d1~28 ivdrip
|
DNR 45mg/m2.d
d1~3,ivdrip,1h,VCR 1.4mg/m2.d
d1,d8,d15,d22 iv,CTX 800mg/m2.d
d1 ivdrip,L-asp 6000u/m2.d
d19~28 ivdrip,Dex10mg.d
d1~28 ivdrip
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CR
Time Frame: From date of randomization until the date of first course of chemotherapy treatment completed, assessed up to 4 weeks.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes of myeloid leukemia stem cells
Time Frame: From date of randomization until the date of first course of chemotherapy treatment completed, assessed up to 4 weeks.
|
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.
|
Collaborators and Investigators
Investigators
- Principal Investigator: zhigang yang, doctor, The Affiliated Hospital of Guangdong Medical College
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, Lymphoid
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Doxorubicin
- Liposomal doxorubicin
- Daunorubicin
Other Study ID Numbers
- 2013ALL-PLD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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