Expired Study
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Memphis, Tennessee 38105


Purpose:

The primary objective is to estimate the overall event-free survival of children at least one year of age at diagnosis who are treated with risk-directed therapy and to monitor the molecular remission induction rate.


Study summary:

These are the following secondary objectives: - To determine if CNS irradiation can be safely omitted in the context of the systemic therapy used in the protocol. - To identify whether prolonged (24 hour) intravenous infusions of HDMTX produce greater methotrexate polyglutamate (MTXPG) accumulation than short (4 hour) infusions 42 hours after 1 gm/m2 of HDMTX, stratified for lineage (T- vs B-lineage) and ploidy (hyperdiploid vs non-hyperdiploid B-lineage). - To determine whether prolonged (24 hour) intravenous infusions of HDMTX produce greater antileukemic effects than short (4 hour) infusions, based on the inhibition of de novo purine synthesis in bone marrow blasts and the decrease in circulating blasts during the 4 day "window" prior to initiation of conventional remission induction therapy. - MRD - Other exploratory objectives Details of Treatment Plan Treatment will consist of three main phases, Remission Induction, Consolidation, and Continuation. Treatment with an Upfront HDMTX Window for research purposes will be optional. All patients will receive IT therapy on day 1, dose is age dependent. Upfront High-Dose Methotrexate Window HDMTX (1 g/m2) as a 4 hour infusion versus as a 24 hour infusion. Leucovorin rescue will be given. Remission Induction Prednisone 40 mg/m2/day PO Days 5 - 32 Vincristine 1.5 mg/m2/week IV Days 5, 12, 19, 26 Daunorubicin 25 mg/m2/week IV Days 5, 12 L-asparaginase 10,000 Unit/m2/dose IM Days 6, 8, 10, 12, 14, 16 (19, 21, 23) Cyclophosphamide 1000 mg/m2/dose IV Day 26 Cytarabine 75 mg/m2/dose IV Days 27-30, 34-37 6-Mercaptopurine 60 mg/m2/dose PO Days 26-39 Imatinib 40 mg/m2 bid for Ph positive patients starting Day 22 of induction. Intrathecal therapy will be administered on day 1 and 19, dose age dependent. Patients with high risk of CNS relapse will receive additional IT treatments on days 8 and 26. Consolidation Treatment High dose methotrexate targeted dose depending on risk status, days 1, 15, 29, and 43 and mercaptopurine 50 mg/m2/day, days 1-56. Reintensification treatment for patients with high risk disease: Patients with high risk disease will be offered the option of hematopoietic stem cell transplant (HSCT) and may receive an additional 1-2 cycles of reintensification treatment prior to maximize the anti-leukemic kill before transplant. Dexamethasone 20 mg/m2 PO days 1-3 Cytarabine 2 g/m2 IV x 4 doses, days 3-5 Etoposide 100 mg/m2 IV x 5 doses, days 3-5 L-asparaginase 25,000 Units/m2 IM day 6 Intrathecal treatment Day 5 Continuation Treatment (lasts 120 weeks for girls and 146 weeks for boys) Treatment will depend on risk classification: low versus standard versus high risk Treatment weeks 1 to 20: Week Standard/High Risk Low Risk 1. DEX + DOX + VCR + 6MP + ASP 6MP + DEX + VCR 2. 6MP + ASP 6MP + MTX 3. 6MP + ASP 6MP + MTX 4. DEX + DOX + VCR + 6MP + ASP 6MP + DEX + VCR 5. 6MP + ASP 6MP + MTX 6. 6MP + ASP 6MP + MTX 7. Reinduction I§ Reinduction I 8. Reinduction I Reinduction I 9. Reinduction I Reinduction I 10. 6MP + ASP 6MP + MTX 11. DOX + VCR + 6MP + ASP 6MP + MTX 12. 6MP + ASP 6MP + MTX 13. 6MP + ASP 6MP + MTX 14. DEX + DOX + VCR + 6MP + ASP 6MP + DEX + VCR 15. 6MP + ASP 6MP + MTX 16. 6MP + ASP 6MP + MTX 17. Reinduction II Reinduction II 18. Reinduction II Reinduction II 19. Reinduction II Reinduction II 20. No chemotherapy 6MP + MTX Dexamethasone 12 mg/m2 (std/high risk) or 8 mg/m2 (low risk) PO daily (tid) x 5 days, Days 1-5 Doxorubicin 30 mg/m2 IV, Day 1 Vincristine 2.0 mg/m2 IV push (max. 2 mg), Day 1 Mercaptopurine 50 mg/m2 PO daily x 7 days (std/high risk), Days 1-7 75 mg/m2 PO daily x 7 days (low risk), Days 1-7 L-asparaginase 25,000 Unit/m2 IM, Day 1 Methotrexate 40 mg/m2 IV or IM, Day 1 Reinduction I and II This phase of treatment will be started at weeks 7 and 17 after bone marrow examination confirms complete remission. Reinduction treatment will be given twice: weeks 7 to 9 and weeks 17 to 19 for all patients. Reinduction I for Standard/High Risk ALL: Dexamethasone 8 mg/m2/day PO (t.i.d.) Days 1-8, 15, 21, Vincristine 1.5 mg/m2/week IV (max 2 mg) Days 1, 8, 15, Doxorubicin 30 mg/m2 Days 1, 8, L-asparaginase 25,000 Unit/m2 IM Days 1, 8, 15, Intrathecal chemotherapy, dose age dependent Day 1. Reinduction II for Standard/High Risk ALL: Dexamethasone 8 mg/m2/day PO (t.i.d.) Days 1-8, 15-21, Vincristine 1.5 mg/m2/week IV (max 2 mg) Days 1, 8, 15, L-asparaginase 25,000 Unit/m2, weekly IM Days 1, 8, 17, Intrathecal chemotherapy, dose age dependent Day 1 High-dose cytarabine 2 gm/m2 IV q 12 Days 15, 16 Reinduction I and II for Low Risk ALL Dexamethasone 8 mg/m2/day PO (t.i.d.) Days 1-8, 15-21 Vincristine 1.5 mg/m2/week IV (max 2 mg), Days 1, 8, 15 L-asparaginase 10,000 Unit/m2/thrice weekly IM Days 2, 4, 6, 8, 10, 12, 15, 17, 19 Doxorubicin 30 mg/m2/week IV Day 1 Intrathecal chemotherapy, dose age dependent on Day 1 Treatment Weeks 21 to end of therapy Week Standard/High Risk Low Risk 21. 6MP + MTX 6MP + MTX 22. 6MP + MTX 6MP + MTX 23. Cyclo + Ara-C 6MP + MTX 24. DEX + VCR 6MP + DEX + VCR 25. 6MP + MTX 6MP + MTX 26. 6MP + MTX 6MP + MTX 27. Cyclo + Ara-C 6MP + MTX 28. DEX + VCR 6MP + DEX + VCR Mercaptopurine 75 mg/m2 PO, daily x 7 days, Days 1-7 Methotrexate 40 mg/m2 IV or IM, Day 1 Cyclophosphamide 300 mg/m2 IV, Day 1 Cytarabine 300 mg/m2 IV, Day 1 Dexamethasone 12 mg/m2 (std/high risk) or 8 mg/m2 (low risk) PO daily (tid) x 5, Day 1-5 Vincristine 2.0 mg/m2 IV push (max. 2 mg), Day 1 The same treatment (weeks 21-28) will be repeated for a total of 6 times (until week 68). After week 68, all patients will receive daily 6MP and weekly MTX with pulses of dexamethasone and vincristine every 4 weeks until week 100, after which only 6MP and methotrexate will be given. Intrathecal treatment will be given every 8 weeks only to patients at high risk of CNS relapse after week 48 and will be discontinued after week 96. Continuation therapy will be discontinued after 120 weeks in girls and after 146 weeks in boys Patients who meet the criteria of high-risk ALL are candidates for allogeneic hematopoietic stem cell transplantation. However, if the option is declined by the patients or guardians, or the procedure is deemed unsuitable by the attending physician and the principal investigator, the patient will remain on study and continue to receive chemotherapy


Criteria:

Inclusion Criteria: - Diagnosis of non-B-cell ALL by immunophenotyping, as determined by the reactivity pattern to a panel of monoclonal antibodies with flow cytometry as well as morphology and cytochemical staining. - Age range: 1 to 18 years (inclusive). Exclusion Criteria: • Previously treated with chemotherapy for one week or longer.


Study is Available At:


Original ID:

TOTXV


NCT ID:

NCT00137111


Secondary ID:

R37CA036401


Study Acronym:


Brief Title:

Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia


Official Title:

Total XV - Total Therapy Study XV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

12 Months


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

St. Jude Children's Research Hospital


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

501


Enrollment Type:

Actual


Overall Contact Information

Official Name:Ching-Hon Pui, M.D.
Principal Investigator
St. Jude Children's Research Hospital

Study Dates

Start Date:July 8, 2000
Completion Date:April 2014
Completion Type:Actual
Primary Completion Date:November 2010
Primary Completion Type:Actual
Verification Date:August 2019
Last Changed Date:August 19, 2019
First Received Date:August 25, 2005
First Results Date:February 28, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Overall Event-free Survival (EFS)
Time Frame:Median follow-up time (range) 5.6 (1.3 to 8.9) years
Safety Issues:False
Description:EFS was measured from the start of on-study to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Failure to enter remission was considered an event at time zero. Measur
Outcome Type:Primary Outcome
Measure:Continuous Complete Remission Since Week 56 Therapy.
Time Frame:Median follow up time (range) 4.5 (1 to 7.8) years
Safety Issues:False
Description:CCR was measured from end of week 56 therapy to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Measurement was determined by Kaplan-Meyer estimate.
Outcome Type:Secondary Outcome
Measure:Minimal Residual Disease (MRD)
Time Frame:End of Induction (Day 46 MRD measurement)
Safety Issues:False
Description:Detection of MRD at end of induction where positive MRD was defined as one or more leukemic cell per 10,000 mononuclear bone-marrow cells (>=0.01%).
Outcome Type:Secondary Outcome
Measure:Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours)
Time Frame:Immediately before the methotrexate infusion and three days after subsequent infusion
Safety Issues:False
Description:White blood cell (leukocytes) counts in peripheral blood by Complete Blood Count Measurement: Percentage change of leukemia cells from baseline
Outcome Type:Secondary Outcome
Measure:Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours).
Time Frame:42 hours after start of high dose methotrexate infusion (HDMTX)
Safety Issues:False
Description:Children were randomly assigned to receive initial single-agent treatment with HDMTX (1g/m^2) as either a 24-hour infusion or a 4-hour infusion and the outcome measure was the accumulation of MTXPG in leukemia cells.

Study Interventions

Intervention Type:Drug
Name:Prednisone, Dexamethasone, Vincristine, Daunorubic
Description:See Detailed Description sections for details on treatment interventions.
Arm Name:1
Intervention Type:Drug
Name:Doxorubicin, L-asparaginase, PEG-L-asparaginase, E
Description:See Detailed Description sections for details on treatment interventions.
Arm Name:1
Intervention Type:Drug
Name:Methotrexate, Cyclophosphamide, Cytarabine, Etopos
Description:See Detailed Description sections for details on treatment interventions.
Arm Name:1
Intervention Type:Drug
Name:Mercaptopurine, Imatinib
Description:See Detailed Description sections for details on treatment interventions.
Arm Name:1
Intervention Type:Procedure
Name:chemotherapy, intrathecal chemotherapy
Description:See Detailed Description sections for details on treatment interventions.
Arm Name:1
Intervention Type:Procedure
Name:steroid therapy, hematopoietic stem cell transplan
Description:See Detailed Description sections for details on treatment interventions.
Arm Name:1

Study Arms

Study Arm Type:Other
Arm Name:1
Study Arm Type:Other
Arm Name:2

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:St. Jude Children's Research Hospital
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

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Reference Type:Reference
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PMID:16041371
Reference Type:Reference
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PMID:16407512
Reference Type:Reference
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PMID:16537802
Reference Type:Reference
Citation:Flotho C, Coustan-Smith E, Pei D, Iwamoto S, Song G, Cheng C, Pui CH, Downing JR, Campana D. Genes contributing to minimal residual disease in childhood acute lymphoblastic leukemia: prognostic significance of CASP8AP2. Blood. 2006 Aug 1;108(3):1050-7. Epub 2006 Apr 20.
PMID:16627760
Reference Type:Reference
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PMID:16423956
Reference Type:Reference
Citation:Cheng Q, Cheng C, Crews KR, Ribeiro RC, Pui CH, Relling MV, Evans WE. Epigenetic regulation of human gamma-glutamyl hydrolase activity in acute lymphoblastic leukemia cells. Am J Hum Genet. 2006 Aug;79(2):264-74. Epub 2006 Jun 6. Erratum in: Am J Hum Genet. 2010 Jul 9;87(1):161.
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Reference Type:Reference
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Reference Type:Reference
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PMID:17510579
Reference Type:Reference
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PMID:17442995
Reference Type:Reference
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PMID:17456722
Reference Type:Reference
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PMID:17926333
Reference Type:Reference
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PMID:18202079
Reference Type:Reference
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PMID:18358930
Reference Type:Reference
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PMID:18416598
Reference Type:Reference
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PMID:26858334
Reference Type:Reference
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PMID:26893509
Reference Type:Reference
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PMID:26856247
Reference Type:Reference
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PMID:26755523
Reference Type:Reference
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PMID:27001572
Reference Type:Reference
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