Modified MRCUKALLⅫ/ECOGE2993 Regimen for ALL

Sun Yat-sen University

Status and phase

Unknown

Phase 2

Conditions

Leukaemia,Lymphoblastic

Treatments

Drug: Etoposide

Drug: Methotrexate

Drug: Cytarabine

Drug: Prednisone

Drug: Cyclophosphamide

Drug: 6-Mercaptopurine

Drug: Intrathecal Methotrexate

Drug: intrathecal cytarabine

Drug: thioguanine

Drug: Daunorubicin

Drug: dexamethasone

Drug: Pegaspargase

Drug: Vincristine

Study type

Interventional

Funder types

Other

Identifiers

NCT02660762

SYSUCC-ALL-5010

Details and patient eligibility

About

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.

Full description

All patients received a modified BFM regimen which was derived from the MRCUKALLⅫ/ECOGE2993 Regimen.The differences were as follows:(1) cranial prophylactic radiotherapy was omitted (2) Pegaspargase was used instead of L- asparaginase for patient.(3)Two additional Pegaspargase treatments were added into consolidation therapy.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

newly diagnosed ALL
age:18-35years
WBC count below 30×109/L(B lineage)；WBC count below 100×109/L(T lineage)
absence of t(9;22), t(1;19), t(4;11) or any other 11q23 rearrangements
receive no chemotherapy or radiotherapy before
Adequate renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

Exclusion criteria

mismatch the inclusion criteria
systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Modified MRCUKALLⅫ/ECOGE2993 Regimen

Experimental group

Description:

All patients received phase 1 of induction therapy, which consisted of daunorubicin,vincristine,Pegaspargase,prednisone and methotrexate (intrathecally).Patients went on to phase 2 at the end of phase 1.Phase 2 therapy consisted of cyclophosphamide,cytarabine,6-Mercaptopurine and methotrexate intrathecally. After Induction therapy, all patients received intensification therapy with high-dose methotrexate followed by Pegaspargase. After intensification therapy,patients received consolidation(cytarabine, etoposide,Pegaspargase,dexamethasone,vincristine,cyclophosphamide,daunorubicin,thioguanine)and maintenance therapy(vincristine,6-mercaptopurine,methotrexate ,prednisone). Intrathecal methotrexate and intrathecal cytarabine were given as CNS prophylaxis.

Treatment: