Pegylated Liposomal Doxorubicin Versus Daunorubicin to Treat Acute Lymphoblastic Leukemia:

NCT02070523 | Unknown Phase 3 DMC

• 1 other identifier: ChangzhouJP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Complete remission (CR) rates after the first course of regimen

  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

  3 years after the last enrollment

Secondary Outcomes (1)

• The change of leukemia stem cells in bone marrow

  3 years after the last enrollment

Study Arms (2)

PLD-contained VDCLD regimen

EXPERIMENTAL

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

DNR-contained VDCLD regimen

ACTIVE COMPARATOR

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

Interventions

VDCLD regimen DRUG

DNR-contained VDCLD regimen; PLD-contained VDCLD regimen

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd.: lead
• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: collaborator

Study Sites (1)

Department of Hematology, Affiliated Hospital of Guangdong Medical College

Zhanjiang, Guangdong, 524000, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Zhigang Yang

  Affiliated Hospital of Guangdong Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi gang Yang

CONTACT

+86 13560512702; 13560512702@139.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 25, 2014
• Study Start: December 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 8, 2014

Record last verified: 2014-02

Locations

CN (1)