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
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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 |

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 |

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.
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Drug: Etoposide, cytarabine, vincristine, dexamethasone
See Detailed Description section for details of treatment interventions.
Other Names:
Drug: methotrexate, teniposide, PEG-asparaginase
See Detailed Description section for details of treatment interventions.
Other Names:
Drug: mitoxantrone, cyclophosphamide, mercaptopurine, vinblastine
See Detailed Description section for details of treatment interventions.
Other Names:
Drug: L-asparaginase, erwinia asparaginase
See Detailed Description section for details of treatment interventions.
Other Names:
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.
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- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | up to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Sima Jeha, MD | St. Jude Children's Research Hospital |
Additional Information:
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 |