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

NCT03419494 | Unknown

• 1 other identifier: 2013ALL-PLD
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• CR

  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 Outcomes (1)

• changes of myeloid leukemia stem cells

  From date of randomization until the date of first course of chemotherapy treatment completed, assessed up to 4 weeks.

Study Arms (2)

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

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

Interventions

PLD 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

Also known as: pegylated liposomal doxorubicin

VDCLD regimen containing PLD

DNR 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

Also known as: Daunorubicin

VDCLD regimen containing DNR

Eligibility Criteria

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

Study Population

This clinical trial will evaluate patients with primary adult ALL who meet the aboving inclusion and exclusion criteria.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Affiliated Hospital of Guangdong Medical University

Guangdong, Guangdong, 524001, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

1-dodecylpyridoxal; liposomal doxorubicin; Daunorubicin

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

Intervention Hierarchy (Ancestors)

Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• zhigang yang, doctor

  Affiliated Hospital of Guangdong Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jiandong nie, doctor

CONTACT

0311-66575708; niejd@mail.ecspc.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: February 5, 2018
• Study Start: October 10, 2013
• Primary Completion: January 31, 2019
• Study Completion: June 30, 2019
• Last Updated: February 5, 2018

Record last verified: 2018-01

Locations

CN (1)