Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03419494
Other study ID # 2013ALL-PLD
Secondary ID
Status Recruiting
Phase N/A
First received January 11, 2018
Last updated January 26, 2018
Start date October 10, 2013
Est. completion date June 30, 2019

Study information

Verified date January 2018
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact jiandong nie, doctor
Phone 0311-66575708
Email niejd@mail.ecspc.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 30, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers No
Gender All
Age group 14 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Adult Acute Lymphoblastic Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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
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

Locations

Country Name City State
China Affiliated Hospital of Guangdong Medical University Guangdong Guangdong

Sponsors (1)

Lead Sponsor Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 changes of myeloid leukemia stem cells to evaluate the changes of myeloid leukemia stem cells in patients before and after induction of VDCLD with PLD and DNR respectively. From date of randomization until the date of first course of chemotherapy treatment completed, assessed up to 4 weeks.
See also
  Status Clinical Trial Phase
Recruiting NCT00188084 - Description and Prognostic Evaluation of Four Biological Parameters of Blast Cells in Adult Acute Lymphoblastic Leukemia N/A
Recruiting NCT02072785 - Phase III Study of Vincristine Sulfate Liposome For Injection In Adults With Naïve Acute Lymphoblastic Leukemia Phase 3
Completed NCT01484015 - Prolonged or Standard Infusion of Cefepime Hydrochloride in Treating Patients With Febrile Neutropenia Phase 1
Recruiting NCT03564704 - Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult T-LBL/ALL Phase 2/Phase 3
Completed NCT00537030 - Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia N/A
Active, not recruiting NCT02159495 - Genetically Modified T-cell Immunotherapy in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia and Persistent/Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm Phase 1
Completed NCT01251575 - Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant Phase 2