Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia - Full Text View

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:

MedlinePlus related topics: Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Dexamethasone Cyclophosphamide Mercaptopurine Methotrexate Vinblastine sulfate Cytarabine Vinblastine Vincristine sulfate Dexamethasone sodium phosphate Asparaginase Methotrexate sodium Teniposide Etoposide Dexamethasone acetate Mitoxantrone Mitoxantrone hydrochloride Etoposide phosphate Pegaspargase

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Lymphosarcoma 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) ] [ 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.

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