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Pegylated Liposomal Doxorubicin Versus Daunorubicin to Treat Acute Lymphoblastic Leukemia:

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ClinicalTrials.gov Identifier: NCT02070523
Recruitment Status : Unknown
Verified February 2014 by Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd..
Recruitment status was:  Recruiting
First Posted : February 25, 2014
Last Update Posted : July 8, 2014
Sponsor:
Collaborator:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Information provided by (Responsible Party):
Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd.

Brief Summary:
To determine, compared with Daunorubicin(DNR), whether Pegylated liposomal doxorubicin (PLD) inducing higher complete remission (CR) rate, in untreated primary ALL adult patients with VDCLD regimen induction therapy. Second, to determine, compared with the DNR, whether chemotherapy containing PLD with a higher response rates and greater safety in adult ALL

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: VDCLD regimen Phase 3

Detailed Description:

This is a prospective, multicenter, open, non-intervention clinical study, with estimated enrollment of 200 newly diagnosed adult ALL patients. After the first course of treatment administered with PLD-contained or DNR-contained VDCLD regimen, CR rate and changes of leukemia stem cells in bone marrow, was evaluated; the safety of these chemotherapy was also evaluated.

Study Patients:

Patients included in this study should be untreated with ALL previously, being in line with the inclusion criteria and exclusion criteria.

Dosage and Administration:

PLD-contained VDCLD regimen:PLD 36 mg/m2 ivdrip over 60 minutes( d1、15),VCR 1.4mg/m iv(d1,8,15,22), CTX 800 mg/m2 ivdrip( d1), L-asp 6000u/m2 ivdrip(d19~28),Dex10mg ivdrip (d1~28).

DNR-contained VDCLD regimen:DNR 45 mg/m2 ivdrip over 60 minutes(d1~3),VCR 1.4mg/m2 iv(d1,d8,d15,d22), CTX 800 mg/m2 ivdrip(d1), L-asp 6000u/m2 ivdrip(d19~28),Dex10mg ivdrip(d1~28).

Endpoints:

Primary endpoint: The primary endpoint of the study was complete remission (CR) rates after the first course of regimen. The proportion of patients achieved CR was evaluated, after the first course of induction chemotherapy administered with PLD-contained or DNR-contained VDCLD regimen Secondary endpoint: The change of leukemia stem cells in bone marrow, was evaluated before and after administered with PLD-contained or DNR-contained VDCLD regimen.

Safety Assessment:

In order to adjust the treatment strategy and ensure patients' safety effectively, routine blood test, transaminases, and creatinine was monitored on time during the period, while lung CT and ECG was performed based on clinical need. Possible adverse reactions and tolerability during treatment, such as gastrointestinal reactions, cardiac function, as well as discontinuation ratio due to side effects or tolerability of PLD, was recorded.

Statistical Analysis:

All the calculations were performed with the SPSS statistical software. The continuous variables were performed with T test; categorical variables were performed withχ2 test. After acceptance of various observation records sheets, data were unified processed.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pegylated Liposomal Doxorubicin-contained Versus Daunorubicin-contained VDCLD Regimen in Previously Untreated Adult Patients With Acute Lymphoblastic Leukemia: Complete Remission Rates and Changes of Leukemia Stem Cells
Study Start Date : December 2013
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: PLD-contained VDCLD regimen
PLD 36 mg/m2 ivdrip over 60 minutes( d1、15),VCR 1.4mg/m iv(d1,8,15,22), CTX 800 mg/m2 ivdrip( d1), L-asp 6000u/m2 ivdrip(d19~28),Dex10mg ivdrip (d1~28).
Drug: VDCLD regimen
Active Comparator: DNR-contained VDCLD regimen
DNR 45 mg/m2 ivdrip over 60 minutes(d1~3),VCR 1.4mg/m2 iv(d1,d8,d15,d22), CTX 800 mg/m2 ivdrip(d1), L-asp 6000u/m2 ivdrip(d19~28),Dex10mg ivdrip(d1~28).
Drug: VDCLD regimen



Primary Outcome Measures :
  1. Complete remission (CR) rates after the first course of regimen [ Time Frame: 3 years after the last enrollment ]
    The primary endpoint of the study was complete remission (CR) rates after the first course of regimen. The proportion of patients achieved CR was evaluated, after the first course of induction chemotherapy administered with PLD-contained or DNR-contained VDCLD regimen


Secondary Outcome Measures :
  1. The change of leukemia stem cells in bone marrow [ Time Frame: 3 years after the last enrollment ]
    The change of leukemia stem cells in bone marrow, was evaluated before and after administered with PLD-contained or DNR-contained VDCLD regimen.



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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligible men or women were age over 14,but less than 60 years;

Eastern Cooperative Oncology Group performance status of 0 to2;

Diagnosed with ALL (WHO classification, the primitive cells ≥ 20%);

Previous untreated ALL patients had not received chemotherapy before (excluding dexamethasone, prednisone, and hydroxyurea). History of receiving blood transfusion, hematopoietic growth factors, vitamin, and palliative measures such as leukocyte removal, dexamethasone, prednisone, hydroxyurea (0.5-3g daily, more than three days) is allowed;

The levels of LSCs in bone marrow were measured with flow cytometry before treatment;

Subjects must be able to provide written informed consent.

Exclusion Criteria:

Mixed type of AL patients;

Clinically significant active infections;

Nursing (breastfeeding) or intending to be nursing during the study;

Pregnancy, or intending to become pregnant during the study;

Patients with cardiac dysfunction currently (especially congestive heart failure) or history of congestive heart failure;

Patients with severe liver failure (ALT ≥ 5 times the upper limit of normal (ULN), total bilirubin ≥ 3mg/dL)

Patients with renal insufficiency, creatinine clearance <30ml/min, creatinine clearance rate is calculated as follows: Men: Ccr (ml / min) = (140 - age) × weight (kg) / [0.8136 × serum creatinine (μmol / L )] female: Ccr (ml / min) = (140 - age) × weight (kg) × 0.85 / [0.8136 × serum creatinine (μmol / L)];

Patients did not or will not participate in other trials of drugs 30 days before or 90 days after the beginning of this study,


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): NCT02070523


Contacts
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Contact: Zhi gang Yang +86 13560512702 13560512702@139.com

Locations
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China, Guangdong
Department of Hematology, Affiliated Hospital of Guangdong Medical College Recruiting
Zhanjiang, Guangdong, China, 524000
Contact: Yang Zhi gang    +86 13560512702    13560512702@139.com   
Principal Investigator: Zhi gang Yang         
Sponsors and Collaborators
Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd.
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
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Principal Investigator: Zhigang Yang The Affiliated Hospital of Guangdong Medical College

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Responsible Party: Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd.
ClinicalTrials.gov Identifier: NCT02070523     History of Changes
Other Study ID Numbers: ChangzhouJP
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
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