Modified MRCUKALLⅫ/ECOGE2993 Regimen for ALL

Summary

This prospective study was conducted to evaluate the efficacy and safety profiles of Modified MRCUKALLⅫ/ECOGE2993 Regimen in young adults with newly diagnosed, low-risk, Philadelphia chromosome negative acute lymphoblastic leukaemia.

Conditions

• Leukaemia,Lymphoblastic

Interventions

DRUG

Vincristine

induction therapy I：1.4 mg/m2 IV d1, 8, 15, 22； consolidation therapy(Cycle 1)：1.4 mg/m2 IV d1, 8, 15, 22； Maintenance therapy: 1.4 mg/m2 intravenously every 3 months for a total of 2.5 years

DRUG

Daunorubicin

induction therapy I：60 mg/m2 IV d1, 8, 15, 22； consolidation therapy(Cycle 3)：25 mg/m2 IV d1, 8, 15, 22；

DRUG

Pegaspargase

induction therapy I: 2500U/m2,im,d8,22 Intensification therapy:2500U/m2 im, d2,23 consolidation therapy(Cycle 2，4)：2500U/m2 im, d1

DRUG

Prednisone

induction therapy I：60 mg/m2 PO d1-28; Maintenance therapy:prednisone 60 mg/m2 orally for 5 days every 3 months for a total of 2.5 years

DRUG

Intrathecal Methotrexate

induction therapy I：12.5 mg IT d15 induction therapy II：12.5 mg IT d1, 8, 15, 22

DRUG

Cyclophosphamide

induction therapy II:650 mg/m2 IV d1, 15, 29 consolidation therapy(Cycle 3)：650 mg/m2 IV，d29

DRUG

Cytarabine

induction therapy II:75 mg/m2 IV d1-4, 8-11, 15-18, 22-25 consolidation therapy(Cycle 1，2，4)：75 mg/m2 intravenously on days 1 to 5 consolidation therapy(Cycle 3):75 mg/m2 intravenously on days 31 to 34 and 38 to 41

DRUG

6-Mercaptopurine

induction therapy II:60 mg/m2 PO d1-28 Maintenance therapy:75 mg/m2 orally each day for a total of 2.5 years

DRUG

Methotrexate

Intensification therapy:3 g/m2 intravenously given on days 1, 8, and 22 Maintenance therapy:20 mg/m2 orally or intravenously once a week for a total of 2.5 years.

DRUG

Etoposide

consolidation therapy(Cycle 1，2，4)：100 mg/m2 intravenously on days 1 to 5

DRUG

dexamethasone

consolidation therapy(Cycle 1)：10mg/m2 orally on days 1 to 28

DRUG

thioguanine

consolidation therapy(Cycle 3): 60 mg/m2 orally on days 29 to 42

DRUG

intrathecal cytarabine

50 mg intrathecal cytarabine was given on 4 occasions 3 months apart during maintenance therapy.

Sponsors & Collaborators

• Sun Yat-sen University

  lead OTHER

Principal Investigators

• yue lu, MD. · Department of Hematological Oncology, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2019-01-31

Completion

2019-01-31

Countries

• China

Study Locations