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Modified MRCUKALLⅫ/ECOGE2993 Regimen for ALL

Primary Purpose

Leukaemia,Lymphoblastic

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Vincristine
Daunorubicin
Pegaspargase
Prednisone
Intrathecal Methotrexate
Cyclophosphamide
Cytarabine
6-Mercaptopurine
Methotrexate
Etoposide
dexamethasone
thioguanine
intrathecal cytarabine
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukaemia,Lymphoblastic

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Modified MRCUKALLⅫ/ECOGE2993 Regimen

Arm 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.

Outcomes

Primary Outcome Measures

progression free survival

Secondary Outcome Measures

overall survival
complete remission rate
Incidence of Treatment-Emergent Adverse Events classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
including hematological safety and non-hematological safety.
Minimal Residual Disease (MRD) monitoring
Minimal residual disease is measured in bone marrow using an multiparameter flow cytometry.For the patients who achieved complete remission after induction therapy, if two consecutive tests for MRD were positive,we will define it as MRD positive

Full Information

First Posted
January 13, 2016
Last Updated
June 16, 2017
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02660762
Brief Title
Modified MRCUKALLⅫ/ECOGE2993 Regimen for ALL
Official Title
A Prospective Phase II Trial of Modified MRC UKALL Ⅻ/ECOG E2993 Regimen in the Treatment of Low Risk Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia for Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukaemia,Lymphoblastic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified MRCUKALLⅫ/ECOGE2993 Regimen
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Other Intervention Name(s)
Vincasar
Intervention Description
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
Intervention Name(s)
Daunorubicin
Other Intervention Name(s)
Cerubidine
Intervention Description
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
Intervention Name(s)
Pegaspargase
Other Intervention Name(s)
Oncaspar
Intervention Description
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
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Prednisone acetate
Intervention Description
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
Intervention Name(s)
Intrathecal Methotrexate
Other Intervention Name(s)
Rheumatrex
Intervention Description
induction therapy I：12.5 mg IT d15 induction therapy II：12.5 mg IT d1, 8, 15, 22
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
induction therapy II:650 mg/m2 IV d1, 15, 29 consolidation therapy(Cycle 3)：650 mg/m2 IV，d29
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
Cytosar-U
Intervention Description
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
Intervention Name(s)
6-Mercaptopurine
Other Intervention Name(s)
Purinethol
Intervention Description
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
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
Rheumatrex
Intervention Description
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
Intervention Name(s)
Etoposide
Other Intervention Name(s)
VePesid
Intervention Description
consolidation therapy(Cycle 1，2，4)：100 mg/m2 intravenously on days 1 to 5
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
Dexamethasone Sodium
Intervention Description
consolidation therapy(Cycle 1)：10mg/m2 orally on days 1 to 28
Intervention Type
Drug
Intervention Name(s)
thioguanine
Other Intervention Name(s)
6-TG
Intervention Description
consolidation therapy(Cycle 3): 60 mg/m2 orally on days 29 to 42
Intervention Type
Drug
Intervention Name(s)
intrathecal cytarabine
Other Intervention Name(s)
Cytosar-U
Intervention Description
50 mg intrathecal cytarabine was given on 4 occasions 3 months apart during maintenance therapy.
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
up to end of follow-up-phase (approximately 3 years)
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
up to end of follow-up-phase (approximately 3 years)
Title
complete remission rate
Time Frame
every 4 weeks,up to completion of induction treatment(approximately 2months)
Title
Incidence of Treatment-Emergent Adverse Events classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Description
including hematological safety and non-hematological safety.
Time Frame
up to end of follow-up-phase (approximately 3 years)
Title
Minimal Residual Disease (MRD) monitoring
Description
Minimal residual disease is measured in bone marrow using an multiparameter flow cytometry.For the patients who achieved complete remission after induction therapy, if two consecutive tests for MRD were positive,we will define it as MRD positive
Time Frame
During treatment at time point 4, 8, 12, 16,20,24, 28 weeks（every 4 weeks,up to completion of consolidation therapy）and 40，52，64，76，88，100，112，124 weeks( every 12 weeks during maintenance therapy,up to the end of treatment )

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hua wang, MD.
Phone
0086-02087342438
Email
wanghua@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yue lu, MD.
Organizational Affiliation
Department of Hematological Oncology, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yue lu, MD.
Phone
0086-02087342438
Email
dr_luyue@sina.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
16105981
Citation
Rowe JM, Buck G, Burnett AK, Chopra R, Wiernik PH, Richards SM, Lazarus HM, Franklin IM, Litzow MR, Ciobanu N, Prentice HG, Durrant J, Tallman MS, Goldstone AH; ECOG; MRC/NCRI Adult Leukemia Working Party. Induction therapy for adults with acute lymphoblastic leukemia: results of more than 1500 patients from the international ALL trial: MRC UKALL XII/ECOG E2993. Blood. 2005 Dec 1;106(12):3760-7. doi: 10.1182/blood-2005-04-1623. Epub 2005 Aug 16.
Results Reference
result

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Modified MRCUKALLⅫ/ECOGE2993 Regimen for ALL

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