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A Study of Children With Refractory or Relapsed ALL

This study has been completed.
Sponsor:
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00187083
First received: September 12, 2005
Last updated: June 3, 2008
Last verified: June 2008
  Purpose

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)


Condition Intervention Phase
Acute Lymphoblastic Leukemia
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Children With Refractory or Relapsed Acute Lymphoblastic Leukemia (ALLR16)

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: December 2003 ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: February 1997
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Native asparaginase
Drug: Topotecan, dexamethasone, vincristine
See Detailed Description section for details of treatment interventions.
Drug: E. coli Asparaginase, PEG-L-asparaginase
See Detailed Description section for details of treatment interventions.
Drug: erwinia asparaginase
See Detailed Description section for details of treatment interventions.
Drug: fludarabine, methotrexate, mercaptopurine
See Detailed Description section for details of treatment interventions.
Drug: idarubicin, etoposide, cytarbine, teniposide
See Detailed Description section for details of treatment interventions.
Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy
See Detailed Description section for details of treatment interventions.
Experimental: 2
PEG-asparaginase
Drug: Topotecan, dexamethasone, vincristine
See Detailed Description section for details of treatment interventions.
Drug: E. coli Asparaginase, PEG-L-asparaginase
See Detailed Description section for details of treatment interventions.
Drug: erwinia asparaginase
See Detailed Description section for details of treatment interventions.
Drug: fludarabine, methotrexate, mercaptopurine
See Detailed Description section for details of treatment interventions.
Drug: idarubicin, etoposide, cytarbine, teniposide
See Detailed Description section for details of treatment interventions.
Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy
See Detailed Description section for details of treatment interventions.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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
  • ECOG score 0-2 Exclusion criteria
  • Life expectancy < 8 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187083

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Sima Jeha, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Name/Official Title: Sima Jeha, MD / Principal Investigator, St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00187083     History of Changes
Other Study ID Numbers: ALLR16
Study First Received: September 12, 2005
Last Updated: June 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:
Leukemia
Acute Lymphoblastic Leukemia
Refractory Acute Lymphoblastic Leukemia
Relapsed Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Asparaginase
Dexamethasone
Methotrexate
Pegaspargase
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Inflammatory Agents
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on November 25, 2014