Modified MRCUKALLⅫ/ECOGE2993 Regimen for ALL

NCT02660762 | Unknown Phase 2 DMC

• 1 other identifier: SYSUCC-ALL-5010
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukaemia,Lymphoblastic

Outcome Measures

Primary Outcomes (1)

• progression free survival

  up to end of follow-up-phase (approximately 3 years)

Secondary Outcomes (4)

• overall survival

  up to end of follow-up-phase (approximately 3 years)

• complete remission rate

  every 4 weeks,up to completion of induction treatment(approximately 2months)

• Incidence of Treatment-Emergent Adverse Events classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

  up to end of follow-up-phase (approximately 3 years)

• Minimal Residual Disease (MRD) monitoring

  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 )

Study Arms (1)

Modified MRCUKALLⅫ/ECOGE2993 Regimen

EXPERIMENTAL

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.

Drug: Vincristine; Drug: Daunorubicin; Drug: Pegaspargase; Drug: Prednisone; Drug: Intrathecal Methotrexate; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: 6-Mercaptopurine; Drug: Methotrexate; Drug: Etoposide; Drug: dexamethasone; Drug: thioguanine; Drug: intrathecal cytarabine

Interventions

Vincristine 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

Also known as: Vincasar

Modified MRCUKALLⅫ/ECOGE2993 Regimen

Daunorubicin DRUG

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

Also known as: Cerubidine

Modified MRCUKALLⅫ/ECOGE2993 Regimen

Pegaspargase 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

Also known as: Oncaspar

Modified MRCUKALLⅫ/ECOGE2993 Regimen

Prednisone 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

Also known as: Prednisone acetate

Modified MRCUKALLⅫ/ECOGE2993 Regimen

Intrathecal Methotrexate DRUG

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

Also known as: Rheumatrex

Modified MRCUKALLⅫ/ECOGE2993 Regimen

Cyclophosphamide DRUG

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

Also known as: Cytoxan

Modified MRCUKALLⅫ/ECOGE2993 Regimen

Cytarabine 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

Also known as: Cytosar-U

Modified MRCUKALLⅫ/ECOGE2993 Regimen

6-Mercaptopurine 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

Also known as: Purinethol

Modified MRCUKALLⅫ/ECOGE2993 Regimen

Methotrexate 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.

Also known as: Rheumatrex

Modified MRCUKALLⅫ/ECOGE2993 Regimen

Etoposide DRUG

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

Also known as: VePesid

Modified MRCUKALLⅫ/ECOGE2993 Regimen

dexamethasone DRUG

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

Also known as: Dexamethasone Sodium

Modified MRCUKALLⅫ/ECOGE2993 Regimen

thioguanine DRUG

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

Also known as: 6-TG

Modified MRCUKALLⅫ/ECOGE2993 Regimen

intrathecal cytarabine DRUG

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

Also known as: Cytosar-U

Modified MRCUKALLⅫ/ECOGE2993 Regimen

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related 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 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.

  PMID: 16105981 RESULT

MeSH Terms

Conditions

Leukemia

Interventions

Vincristine; Daunorubicin; pegaspargase; Prednisone; Methotrexate; Cyclophosphamide; Cytarabine; Mercaptopurine; Etoposide; Dexamethasone; Thioguanine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Aminopterin; Pterins; Pteridines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Sulfhydryl Compounds; Sulfur Compounds; Purines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Pregnadienetriols; Steroids, Fluorinated

Study Officials

• yue lu, MD.

  Department of Hematological Oncology, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hua wang, MD.

CONTACT

0086-02087342438; wanghua@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 21, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: June 19, 2017

Record last verified: 2017-06

Locations

CN (1)