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Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia
This study has been completed.
Sponsor:
St. Jude Children's Research Hospital
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00186875
First received: September 1, 2005
Last updated: July 26, 2017
Last verified: June 2017
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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: | 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 |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Lymphosarcoma
Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
U.S. FDA Resources
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) ]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.
Other Outcome Measures:
- 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.
| Enrollment: | 47 |
| Study Start Date: | November 2003 |
| Study Completion Date: | August 2016 |
| 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:
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.
|
Show Detailed Description
Eligibility| 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
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
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: | Sima Jeha, MD | St. Jude Children's Research Hospital |
More Information
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 ) |
| Study First Received: | September 1, 2005 |
| Results First Received: | October 25, 2013 |
| Last Updated: | July 26, 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 |
ClinicalTrials.gov processed this record on September 19, 2017