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Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00186875
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : December 16, 2013
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment 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

  Show Detailed Description

Study Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia
Study Start Date : November 2003
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Response Rate [ Time Frame: End of re-induction Block C (approximately 1 month after the start of therapy) ]
    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.

  2. Overall Survival (OS) [ Time Frame: 2 years after last patient completes therapy (approximately 4 years after enrollment) ]
    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. The probability of survival at 5 years after diagnosis is given.


Other Outcome Measures:
  1. Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111) [ Time Frame: End of Block Block C therapy (Day 46) ]
    The prevalence of MRD in children undergoing treatment for relapsed ALL and to compare the results to those obtained in children with newly diagnosed ALL. MRD is considered as positive (i.e., prevalent) if its level is >=0.01%. The prevalence of MRD after Block C is defined as the proportion of MRD positives.

  2. Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111) [ Time Frame: End of Block B therapy (Day 19) ]
    The prevalence of MRD in children undergoing treatment for relapsed ALL and to compare the results to those obtained in children with newly diagnosed ALL. MRD is considered as positive (i.e., prevalent) if its level is >=0.01%. The prevalence of MRD after Block B is defined as the proportion of MRD positives.


Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Sima Jeha, MD St. Jude Children's Research Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
St. Jude Children's Research Hospital  This link exits the ClinicalTrials.gov site
Clinical Trials Open at St. Jude  This link exits the ClinicalTrials.gov site

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00186875     History of Changes
Other Study ID Numbers: ALLR17
NCI-2011-01256 ( Registry Identifier: NCI Clinical Trial Registration Program )
First Posted: September 16, 2005    Key Record Dates
Results First Posted: December 16, 2013
Last Update Posted: July 28, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Etoposide phosphate
Pegaspargase
Cyclophosphamide
Methotrexate
 Etoposide
Cytarabine
Vincristine
Mitoxantrone
Asparaginase
6-Mercaptopurine
Vinblastine
Teniposide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents