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CompletedNCT00165178Updated Apr 25, 2013

Treatment of Acute Lymphoblastic Leukemia in Children

A Phase 3 interventional study of prednisone and dexamethasone in Acute Lymphoblastic Leukemia, sponsored by Dana-Farber Cancer Institute. Completed at 1 site in United States. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2013-04-25.

Sponsored by Dana-Farber Cancer Institute · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
498
Allocation
Randomized
Ages
1 Year to 18 Years
Sex
All
01

Study summary

The purpose of this study is to reduce the side-effects from anti-leukemia therapy. The therapy in this study is based upon treatment information learned from prior clinical research programs as well as from laboratory research.

Read the detailed description
  • Children with acute lymphoblastic leukemia are treated somewhat differently depending on the relative risk of the leukemia recurring. Patients will be separated into "Standard Risk" and "High Risk".
  • The treatment program for both groups is separated into 4 phases. The phases of treatment are induction, central nervous system (CNS) therapy, intensification and continuation.
  • The induction phase of therapy lasts for about one month and its purpose is to kill all detectable leukemia cells. Patients in both groups will receive the following medication: prednisone, vincristine, doxorubicin, methotrexate, leucovorin, asparaginase, cytarabine (ARA-C), and hydrocortisone. Patients in the "Hight Risk" group will also receive dexrazoxane.
  • Patients whose leukemia is found to have a specific genetic abnormality involving a gene on chromosome 11 (known as MLL gene) will have a MLL intensification phase which begins after complete remission and lasts about 1 month. The drugs involved in MLL intensification are: vincristine, methotrexate, leucovorin, hydrocortisone, cytarabine and L-asparaginase.
  • CNS therapy begins immediately after the end of induction therapy, after remission is documented. This phase of treatment should last 3 weeks and includes a series of spinal taps with the instillation of anti-leukemia drugs. Four spinal taps will be performed over a two-week period. Both groups will receive vincristine, 6-mercaptopurine and methotrexate/cytarabine/hydrocortisone. Patients in the "High Risk" group will also receive doxorubicin with dexrazoxane.
  • Radiation therapy will also be delivered to patients in the "High Risk" group during the CNS therapy phase. Radiation will be given in 8 daily treatments. The total dose of radiation used during this study is lower than what has been used in the past to help reduce side effects without increasing the risk of relapse.
  • The intensification phase begins after the CNS therapy ends and lasts for 30 weeks. This phase is intended to further reduce the number of leukemia cells in the body and consists of cycles of chemotherapy repeated every three weeks with weekly shots of asparaginase. The drugs administered to both groups during this phase are: prednisone or dexamethasone, vincristine,6-mercaptopurine, methotrexate, E. coli asparaginase and cytarabine. Patients in the "High Risk" group will also receive doxorubicin and dexrazoxane.
  • The continuation phase begins after the completion of the intensification phase and the goal is to eradicate all leukemia from the body. It consists of cycles of chemotherapy repeated every 3 weeks and is continued until the patient has been in remission for 2 years. The drugs administered during this phase are vincristine, prednisone or dexamethasone, 6-mercaptopurine, methotrexate and cytarabine.
  • During this trial there are two randomizations, each is between the "standard" treatment and the "investigational" treatment. One randomization involves the drug E. coli L-asparaginase and two ways of dosing this drug. One way is to give the same standard dose of the drug that has been administered for years. The other way is to start with a lower dose and measure the amount of the drug in the blood every 3 weeks adjusting the dose as necessary. The goal of doing this is to maintain adequate drug levels with lower doses in the hope the it may reduce some side effects of the drug.
  • The second randomization involves the drugs prednisone and dexamethasone. Both drugs have been used in the past to help treat ALL but it is not known if there is a difference between the two drugs, especially in terms of side effects. Patients will be randomized to either receive dexamethasone or prednisone.
  • Throughout the study blood tests, urine tests, spinal taps, and bone marrow tests will be performed to monitor the disease status, side effects from medications and other complications from therapy.
  • Quality of life questionnaires will also be performed by the patient (if older than 8), parent and patient's clinician.
02

Conditions studied

  • Acute Lymphoblastic Leukemia

Keywords

  • Acute lymphoblastic leukemia in children
  • High Risk ALL
  • Standard Risk ALL
  • E. coli asparaginase
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 498 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Acute lymphoblastic leukemia excluding known mature B-cell ALL by the presence of any of the following: surface immunoglobulin, L3 morphology, t(8;14) (q24;q32), t(8;22) or t(2;8)
  • Age > 12 months but less than 18 years

Exclusion criteria

Exclusion Criteria:

  • Prior therapy except, 1 week of steroids, or emergent radiation therapy to the mediastinum
  • Known HIV positive
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
498 participants (actual)

Study arms

  • Experimental
    Individualized ASP dose

    Drug: doxorubicin · Drug: E. coli asparaginase · Drug: vincristine · Drug: methotrexate · Drug: Leucovorin · Drug: cytarabine · Drug: Methotrexate/Hydrocortisone

  • Active comparator
    Fixed dose ASP

    Drug: doxorubicin · Drug: E. coli asparaginase · Drug: vincristine · Drug: methotrexate · Drug: Leucovorin · Drug: cytarabine · Drug: Methotrexate/Hydrocortisone

  • Experimental
    Dexamethasone

    Drug: dexamethasone · Drug: doxorubicin · Drug: vincristine · Drug: methotrexate · Drug: Leucovorin · Drug: Asparaginase · Drug: cytarabine · Drug: Methotrexate/Hydrocortisone

  • Active comparator
    Prednisone

    Drug: prednisone · Drug: doxorubicin · Drug: vincristine · Drug: methotrexate · Drug: Leucovorin · Drug: Asparaginase · Drug: cytarabine · Drug: Methotrexate/Hydrocortisone

Interventions

  • Drugprednisone

    Induction Phase: Given orally or intravenously Days 0-28 Intensification Phase: Given orally Days 1-5 of each cycle Continuation Phase: Given orally Days 1-5 of each cycle

  • Drugdexamethasone

    Intensification Phase: Given orally days 1-5 of each cycle Continuation Phase: Given orally days 1-5 pf each cycle

  • Drugdoxorubicin

    Induction Phase: Intravenously on Days 0,1 Intensification Phase: Intravenously on Day 1 of each cycle

    Also known as: dexrazoxane

  • DrugE. coli asparaginase

    Intensification Phase: In the muscle weekly. Dose will vary

  • Drugvincristine

    Induction: Intravenously on days 0, 7, 14, 21 MLL Intensification Phase: Intravenously on Days 1, 8, 15, 22 CNS Therapy: Intravenously on Day 1 Intensification Phase: Intravenously on day 1 of each cycle Continuation Phase: Intravenously on Day 1 of each cycle

  • Drugmethotrexate

    Induction: Intravenously on Day 2 MLL Intensification: Intravenously on Days 1, 8 Intensification: (when doxorubicin completed) Intravenously or into the muscle weekly Continuation: Intravenously or into the muscle weekly

  • DrugLeucovorin

    Induction Phase: Intravenously or orally begins 36 hours after methotrexate MLL Intensification: Intravenously or orally begins 36 hours after methotrexate

  • DrugAsparaginase

    Induction: Into the muscle on Day 4 MLL Intensification: Into the muscle on Days 16, 23

  • Drugcytarabine

    Induction: Intrathecal on Days 0, 14, 28 MLL Intensification: Intravenously on Days 15, 16, 22, 23

    Also known as: ARA-C

  • DrugMethotrexate/Hydrocortisone

    Induction: Intrathecal on Days 14, 28 MLL Intensification: Intrathecal on Days 2,9

06

What researchers measure

Primary outcomes

  1. To optimize dosing of E. coli L-asparaginase during the intensification period

    Time frame: 5 years

  2. To determine the side effects of prednisone versus dexamethasone.

    Time frame: 5 years

Secondary outcomes

  1. To compare randomized treatment groups using health-related, quality-of-life analysis

    Time frame: 5 years

07

Study locations

1 site
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
08

References and documents

Publications

  • Silverman LB, Gelber RD, Dalton VK, Asselin BL, Barr RD, Clavell LA, Hurwitz CA, Moghrabi A, Samson Y, Schorin MA, Arkin S, Declerck L, Cohen HJ, Sallan SE. Improved outcome for children with acute lymphoblastic leukemia: results of Dana-Farber Consortium Protocol 91-01. Blood. 2001 Mar 1;97(5):1211-8. doi: 10.1182/blood.v97.5.1211. PubMed 11222362 ↗
  • Silverman LB, Declerck L, Gelber RD, Dalton VK, Asselin BL, Barr RD, Clavell LA, Hurwitz CA, Moghrabi A, Samson Y, Schorin MA, Lipton JM, Cohen HJ, Sallan SE. Results of Dana-Farber Cancer Institute Consortium protocols for children with newly diagnosed acute lymphoblastic leukemia (1981-1995). Leukemia. 2000 Dec;14(12):2247-56. doi: 10.1038/sj.leu.2401980. PubMed 11187916 ↗
  • Goldberg JM, Silverman LB, Levy DE, Dalton VK, Gelber RD, Lehmann L, Cohen HJ, Sallan SE, Asselin BL. Childhood T-cell acute lymphoblastic leukemia: the Dana-Farber Cancer Institute acute lymphoblastic leukemia consortium experience. J Clin Oncol. 2003 Oct 1;21(19):3616-22. doi: 10.1200/JCO.2003.10.116. PubMed 14512392 ↗
  • Lipshultz SE, Rifai N, Dalton VM, Levy DE, Silverman LB, Lipsitz SR, Colan SD, Asselin BL, Barr RD, Clavell LA, Hurwitz CA, Moghrabi A, Samson Y, Schorin MA, Gelber RD, Sallan SE. The effect of dexrazoxane on myocardial injury in doxorubicin-treated children with acute lymphoblastic leukemia. N Engl J Med. 2004 Jul 8;351(2):145-53. doi: 10.1056/NEJMoa035153. PubMed 15247354 ↗
  • Vrooman LM, Stevenson KE, Supko JG, O'Brien J, Dahlberg SE, Asselin BL, Athale UH, Clavell LA, Kelly KM, Kutok JL, Laverdiere C, Lipshultz SE, Michon B, Schorin M, Relling MV, Cohen HJ, Neuberg DS, Sallan SE, Silverman LB. Postinduction dexamethasone and individualized dosing of Escherichia Coli L-asparaginase each improve outcome of children and adolescents with newly diagnosed acute lymphoblastic leukemia: results from a randomized study--Dana-Farber Cancer Institute ALL Consortium Protocol 00-01. J Clin Oncol. 2013 Mar 20;31(9):1202-10. doi: 10.1200/JCO.2012.43.2070. Epub 2013 Jan 28. PubMed 23358966 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00165178
Lead sponsor
Dana-Farber Cancer Institute
Collaborators
Boston Children's Hospital, University of Rochester, McMaster University, San Jorge Children's Hospital (Puerto Rico), St. Justine's Hospital, Maine Children's Cancer Program, Ochsner Health System, Tulane University School of Medicine, Laval University, Columbia University
Responsible party
Lewis B. Silverman, M.D. (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
Sep 14, 2005
Start date
Sep 2000
Primary completion
Dec 2004
Completion
May 2011
Last update
Apr 25, 2013

Study contacts

Lewis Silverman, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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