Modified MRCUKALLⅫ/ECOGE2993 Regimen for ALL

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Leukaemia,Lymphoblastic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Modified MRCUKALLⅫ/ECOGE2993 Regimen

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.

Group Type EXPERIMENTAL

Vincristine

Intervention Type DRUG

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

Daunorubicin

Intervention Type DRUG

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

Pegaspargase

Intervention Type DRUG

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

Prednisone

Intervention Type DRUG

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

Intrathecal Methotrexate

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

6-Mercaptopurine

Intervention Type DRUG

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

Methotrexate

Intervention Type DRUG

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.

Etoposide

Intervention Type DRUG

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

dexamethasone

Intervention Type DRUG

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

thioguanine

Intervention Type DRUG

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

intrathecal cytarabine

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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；

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Intrathecal Methotrexate

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

Intervention Type DRUG

Cyclophosphamide

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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Intervention Type DRUG

Etoposide

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

Intervention Type DRUG

dexamethasone

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

Intervention Type DRUG

thioguanine

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

Intervention Type DRUG

intrathecal cytarabine

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

Intervention Type DRUG

Other Intervention Names

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Vincasar Cerubidine Oncaspar Prednisone acetate Rheumatrex Cytoxan Cytosar-U Purinethol Rheumatrex VePesid Dexamethasone Sodium 6-TG Cytosar-U

Eligibility Criteria

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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)

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No