NCT00165087

Brief Summary

The purpose of this study is to reduce the side-effects and discomfort of anti-leukemia therapy, to attain long-term control of the disease and to hopefully eradicate it.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
491

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 1996

Longer than P75 for phase_3

Geographic Reach
3 countries

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

Enrollment Period

10.7 years

First QC Date

September 9, 2005

Last Update Submit

December 20, 2007

Conditions

Acute Lymphoblastic Leukemia

Keywords

childhood ALLstandard riskhigh riskinfant/high risk

Outcome Measures

Primary Outcomes (4)

  • -To evaluate the efficacy and safety of doxorubicin with or without dexrazoxane

  • -To determine the efficacy of hyperfractionated radiation plus standard intrathecal chemotherapy compared with intensive intrathecal chemotherapy alone in standard risk patients.

  • -To compare the relative efficacy and toxicity of E.coli and Erwinia asparaginase

  • -To compare the relative efficacy and toxicity of cranial radiation delivered in once-daily versus twice-daily fractions in high risk patinets.

Secondary Outcomes (1)

  • -To compare randomized treatment groups using health-related quality of life analyses.

Interventions

asparaginase (E. Coli)DRUG
asparaginase (Erwina)DRUG
dexrazoxaneDRUG
doxorubicinDRUG
cranial radiation (once daily fractionation)PROCEDURE
cranial radiation (twice-daily fractionation)PROCEDURE
Intrathecal chemotherapy without radiationPROCEDURE

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Acute lymphoblastic leukemia, excluding known mature B-cell ALL
  • \< 18 years of age
  • Patients who are leukopheresed or exchanged are eligible for study only after completion of the pheresis or exchange transfusion
  • Absence of a t(8,14) (q24; q32), t (8,22), t(2,8)
  • Total bilirubin \< 1.4mg/dl

You may not qualify if:

  • Known HIV positive
  • Prior steroid therapy within 30 days of diagnosis
  • Septic shock
  • Ongoing intracranial hemorrhage
  • Clinical evidence of CNS or lung leukostasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Ochsner Clinic

New Orleans, Louisiana, 70121, United States

Location

Maine Medical Center

Lewiston, Maine, 04240, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Mt. Sinai Medical Center

New York, New York, 10029, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

McMaster University

Hamilton, Ontario, Canada

Location

Laval University

Montreal, Quebec, Canada

Location

Sainte Justine Hosptial

Montreal, Quebec, Canada

Location

San Jorge Children's Hospital

Santurce, 00912, Puerto Rico

Location

Related Publications (7)

  • 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.

    PMID: 11187916BACKGROUND

  • 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.

    PMID: 11222362BACKGROUND

  • 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.

    PMID: 14512392BACKGROUND

  • 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.

    PMID: 15247354RESULT

  • Waber DP, Silverman LB, Catania L, Mautz W, Rue M, Gelber RD, Levy DE, Goldwasser MA, Adams H, Dufresne A, Metzger V, Romero I, Tarbell NJ, Dalton VK, Sallan SE. Outcomes of a randomized trial of hyperfractionated cranial radiation therapy for treatment of high-risk acute lymphoblastic leukemia: therapeutic efficacy and neurotoxicity. J Clin Oncol. 2004 Jul 1;22(13):2701-7. doi: 10.1200/JCO.2004.10.173.

    PMID: 15226337RESULT

  • Burns MA, Place AE, Stevenson KE, Gutierrez A, Forrest S, Pikman Y, Vrooman LM, Harris MH, Hunt SK, O'Brien JE, Asselin BL, Athale UH, Clavell LA, Cole PD, Gennarini LM, Kahn JM, Kelly KM, Laverdiere C, Leclerc JM, Michon B, Schorin MA, Sulis ML, Welch JJG, Neuberg DS, Sallan SE, Silverman LB. Identification of prognostic factors in childhood T-cell acute lymphoblastic leukemia: Results from DFCI ALL Consortium Protocols 05-001 and 11-001. Pediatr Blood Cancer. 2021 Jan;68(1):e28719. doi: 10.1002/pbc.28719. Epub 2020 Oct 7.

    PMID: 33026184DERIVED

  • Lipshultz SE, Scully RE, Lipsitz SR, Sallan SE, Silverman LB, Miller TL, Barry EV, Asselin BL, Athale U, Clavell LA, Larsen E, Moghrabi A, Samson Y, Michon B, Schorin MA, Cohen HJ, Neuberg DS, Orav EJ, Colan SD. Assessment of dexrazoxane as a cardioprotectant in doxorubicin-treated children with high-risk acute lymphoblastic leukaemia: long-term follow-up of a prospective, randomised, multicentre trial. Lancet Oncol. 2010 Oct;11(10):950-61. doi: 10.1016/S1470-2045(10)70204-7. Epub 2010 Sep 16.

    PMID: 20850381DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

AsparaginaseDexrazoxaneDoxorubicinRadiation

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AmidohydrolasesHydrolasesEnzymesEnzymes and CoenzymesRazoxaneDiketopiperazinesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhysical Phenomena

Study Officials

  • Stephen E. Sallan, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

January 1, 1996

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

PR(1)US(6)CA(3)