Comparison of Liposomal Doxorubicin and Daunorubicin-containing VDCLD Regimen in the Treatment of Adult ALL Patients

NCT ID: NCT03419494

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-10
• Study Completion Date: 2019-06-30

Brief Summary

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.

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.

Conditions

Adult Acute Lymphoblastic Leukemia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

PLD

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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

Interventions

PLD

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

Intervention Type: DRUG

DNR

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

Intervention Type: DRUG

Other Intervention Names

pegylated liposomal doxorubicin; Daunorubicin

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

zhigang yang, doctor

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Guangdong Medical University

Locations

Affiliated Hospital of Guangdong Medical University

Guangdong, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

jiandong nie, doctor

Role: CONTACT

niejd@mail.ecspc.com

0311-66575708

Facility Contacts

honghua he, doctor

Role: primary

192880@qq.com

13828229695

Other Identifiers

2013ALL-PLD

Identifier Type: -

Identifier Source: org_study_id