A Study of Children With Refractory or Relapsed ALL

NCT00187083 | Completed Phase 3

• 1 other identifier: ALLR16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to find out which form of asparaginase (the native E. coli/Erwinia) or PEG-asparaginase) is more effective during induction treatment for children with acute lymphoblastic leukemia that has come back after treatment (relapsed) or is resistant to treatment (refractory)

Conditions

Acute Lymphoblastic Leukemia

Keywords

Leukemia; Acute Lymphoblastic Leukemia; Refractory Acute Lymphoblastic Leukemia; Relapsed Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• To compare in a randomized trial the depletion of asparagine in patients who receive the native form of asparaginase or PEG-asparaginase during induction therapy.

  December 2003

Study Arms (2)

1

EXPERIMENTAL

Native asparaginase

Drug: Topotecan, dexamethasone, vincristine; Drug: E. coli Asparaginase, PEG-L-asparaginase; Drug: erwinia asparaginase; Drug: fludarabine, methotrexate, mercaptopurine; Drug: idarubicin, etoposide, cytarbine, teniposide; Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy

2

EXPERIMENTAL

PEG-asparaginase

Drug: Topotecan, dexamethasone, vincristine; Drug: E. coli Asparaginase, PEG-L-asparaginase; Drug: erwinia asparaginase; Drug: fludarabine, methotrexate, mercaptopurine; Drug: idarubicin, etoposide, cytarbine, teniposide; Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy

Interventions

Topotecan, dexamethasone, vincristine DRUG

See Detailed Description section for details of treatment interventions.

1; 2

E. coli Asparaginase, PEG-L-asparaginase DRUG

See Detailed Description section for details of treatment interventions.

1; 2

erwinia asparaginase DRUG

See Detailed Description section for details of treatment interventions.

1; 2

fludarabine, methotrexate, mercaptopurine DRUG

See Detailed Description section for details of treatment interventions.

1; 2

idarubicin, etoposide, cytarbine, teniposide DRUG

See Detailed Description section for details of treatment interventions.

1; 2

chemotherapy, intrathecal chemotherapy, steroid therapy PROCEDURE

See Detailed Description section for details of treatment interventions.

1; 2

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• For patients treated on frontline protocols at St. Jude:
• ALL in isolated bone marrow relapse, or combined marrow and extramedullary relapse, during or after treatment with multi-agent chemotherapy (TOTAL XI, XII, XIIIA, XIIIB), or isolated extramedullary relapse after treatment on TOTXII.
• Patients with recurrent T-Cell non-Hodgkin's lymphoma who relapse in the bone marrow with \>25% blasts
• For patients not treated on front-line St. Jude protocols:
• ALL in isolated bone marrow relapse, or isolated extramedullary relapse, or combined marrow and extramedullary relapse.
• All patients:
• First relapse after receiving primary therapy or during primary therapy
• Life expectance of at least 8 weeks

You may not qualify if:

• Life expectancy \< 8 weeks

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia

Interventions

Topotecan; Dexamethasone; Vincristine; pegaspargase; asparaginase erwinia chrysanthemi recombinant; fludarabine; Methotrexate; Mercaptopurine; Idarubicin; Etoposide; Teniposide; Drug Therapy

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Aminopterin; Pterins; Pteridines; Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Purines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Therapeutics

Study Officials

• Sima Jeha, MD

  St. Jude Children's Research Hospital

  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 12, 2005
• First Posted: September 16, 2005
• Study Start: February 1, 1997
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2003
• Last Updated: June 4, 2008

Record last verified: 2008-06

Locations

US (1)