Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00186875
First received: September 1, 2005
Last updated: April 17, 2014
Last verified: October 2013
  Purpose

The main purpose of this study is to find out how well participants with relapsed or refractory ALL respond to treatment with an etoposide- and teniposide-based induction chemotherapy regimen and what the side effects are.

Primary Objectives:

  • To estimate the response rate for patients with refractory or relapsed ALL.
  • To estimate the survival rate of patients with refractory or relapsed ALL treated with risk-directed therapy.

Condition Intervention Phase
Acute Lymphoblastic Leukemia
Lymphoma, Lymphoblastic
Drug: Etoposide, cytarabine, vincristine, dexamethasone
Drug: methotrexate, teniposide, PEG-asparaginase
Drug: mitoxantrone, cyclophosphamide, mercaptopurine, vinblastine
Drug: L-asparaginase, erwinia asparaginase
Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy
Procedure: Hematopoietic Stem Cell Transplant
Procedure: Natural Killer (NK) Cell Transplant
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response Rate [ Time Frame: End of re-induction Block C (approximately 1 month after the start of therapy) ] [ Designated as safety issue: No ]
    The "response rate" is defined as the proportion of participants who attain morphological complete remission after the re-induction Block C, inclusive of all patients who begin re-induction. Morphological complete remission was defined as <5% blasts in bone marrow by morphology.

  • Overall Survival (OS) [ Time Frame: 2 years after last patient completes therapy (approximately 4 years after enrollment) ] [ Designated as safety issue: No ]
    OS is measured from the start of on-study to the date of death or to the last date of follow-up. Measurement is determined by Kaplan-Meyer estimate.


Enrollment: 47
Study Start Date: November 2003
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment
Participants receive chemotherapy, intrathecal chemotherapy, steroid therapy, hematopoietic stem cell transplant, and natural killer cell transplant as outlined in the Interventions section, including etoposide, cytarabine, vincristine, dexamethasone, methotrexate, teniposide, PEG-asparaginase, mitoxantrone, cyclophosphamide, mercaptopurine, vinblastine, L-asparaginase, erwinia asparaginase.
Drug: Etoposide, cytarabine, vincristine, dexamethasone
See Detailed Description section for details of treatment interventions.
Other Names:
  • etoposide: VP-16, Vepesid(R)
  • cytarabine: Ara-C, Cytosar-U(R)
  • vincristine: Oncovin(R)
  • dexamethasone: Decadron(R)
Drug: methotrexate, teniposide, PEG-asparaginase
See Detailed Description section for details of treatment interventions.
Other Names:
  • methotrexate: MTX
  • teniposide: VM-26, Vumon(R)
  • PEG-asparaginase: Peg-L-Asparaginase, pegaspargase, Oncaspar(R)
Drug: mitoxantrone, cyclophosphamide, mercaptopurine, vinblastine
See Detailed Description section for details of treatment interventions.
Other Names:
  • mitoxantrone: Novantrone(R)
  • cyclophosphamide: Cytoxan(R)
  • mercaptopurine: 6-MP, Purinethol(R)
  • vinblastine: Velban(R)
Drug: L-asparaginase, erwinia asparaginase
See Detailed Description section for details of treatment interventions.
Other Names:
  • L-asparaginase: Elspar(R)
  • erwinia asparaginase: Erwinase(R)
Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy
See Detailed Description section for details of treatment interventions.
Procedure: Hematopoietic Stem Cell Transplant
See Detailed Description section for details of treatment interventions.
Procedure: Natural Killer (NK) Cell Transplant
See Detailed Description section for details of treatment interventions.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Childhood ALL in first relapse OR in first hematological relapse after an extramedullary relapse, OR not attaining a complete remission with frontline therapies, OR lymphoblastic leukemia in first relapse.
  • Patients must be 21 years of age or younger
  • Informed consent explained to and signed by parent/legal guardian.

Exclusion Criteria

  • Life expectancy less than 8 weeks
  • Patients with mature B cell ALL
  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: NCT00186875

Locations
United States, California
Rady Children's Hospital and Health Center
San Diego, California, United States, 92123
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: Deepa Bhojwani, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00186875     History of Changes
Other Study ID Numbers: ALLR17
Study First Received: September 1, 2005
Results First Received: October 25, 2013
Last Updated: April 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:
Leukemia
Lymphoblastic
Acute
Lymphoma
Non-Hodgkin's

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Cytarabine
Methotrexate
Cyclophosphamide
Teniposide
Etoposide phosphate
Pegaspargase
Asparaginase
Dexamethasone
Etoposide
Mitoxantrone
Vinblastine
Vincristine
BB 1101
Dexamethasone acetate
Dexamethasone 21-phosphate
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on July 20, 2014