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

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ClinicalTrials.gov Identifier: NCT03419494
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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.

Condition or disease Intervention/treatment
Adult Acute Lymphoblastic Leukemia Drug: PLD Drug: DNR

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 : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
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.
Actual Study Start Date : October 10, 2013
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : June 30, 2019


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
Drug: 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
Other Name: pegylated liposomal doxorubicin

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
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
Other Name: Daunorubicin




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This clinical trial will evaluate patients with primary adult ALL who meet the aboving inclusion and exclusion criteria.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419494


Contacts
Contact: jiandong nie, doctor 0311-66575708 niejd@mail.ecspc.com

Locations
China, Guangdong
Affiliated Hospital of Guangdong Medical University Recruiting
Guangdong, Guangdong, China, 524001
Contact: honghua he, doctor    13828229695    192880@qq.com   
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
Principal Investigator: zhigang yang, doctor Affiliated Hospital of Guangdong Medical University

Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03419494     History of Changes
Other Study ID Numbers: 2013ALL-PLD
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Liposomal doxorubicin
Daunorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action