Modified MRCUKALLⅫ/ECOGE2993 Regimen for ALL

Leukaemia,Lymphoblastic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02660762
• Other study ID #: SYSUCC-ALL-5010
• Status: Recruiting
• Phase: Phase 2
• First received: January 13, 2016
• Last updated: June 16, 2017
• Start date: January 2016
• Est. completion date: January 2019

Study information

• Verified date: June 2017
• Source: Sun Yat-sen University
• Contact: hua wang, MD.
• Phone: 0086-02087342438
• Email: wanghua[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukaemia,Lymphoblastic
• Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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
• Daunorubicin
induction therapy I:60 mg/m2 IV d1, 8, 15, 22; consolidation therapy(Cycle 3):25 mg/m2 IV d1, 8, 15, 22;
• 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
• 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
• Intrathecal Methotrexate
induction therapy I:12.5 mg IT d15 induction therapy II:12.5 mg IT d1, 8, 15, 22
• Cyclophosphamide
induction therapy II:650 mg/m2 IV d1, 15, 29 consolidation therapy(Cycle 3):650 mg/m2 IV,d29
• 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
• 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
• 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.
• Etoposide
consolidation therapy(Cycle 1,2,4):100 mg/m2 intravenously on days 1 to 5
• dexamethasone
consolidation therapy(Cycle 1):10mg/m2 orally on days 1 to 28
• thioguanine
consolidation therapy(Cycle 3): 60 mg/m2 orally on days 29 to 42
• intrathecal cytarabine
50 mg intrathecal cytarabine was given on 4 occasions 3 months apart during maintenance therapy.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

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 lymphobla — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		up to end of follow-up-phase (approximately 3 years)
Secondary	overall survival		up to end of follow-up-phase (approximately 3 years)
Secondary	complete remission rate		every 4 weeks,up to completion of induction treatment(approximately 2months)
Secondary	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.	up to end of follow-up-phase (approximately 3 years)
Secondary	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	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 )