Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia

• 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: St. Jude Children's Research Hospital
• Information provided by (Responsible Party): St. Jude Children's Research Hospital

Study Description

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

• 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

Arms and Interventions

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

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

• 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

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:

St. Jude Children's Research Hospital  Clinical Trials Open at St. Jude 

• 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
• 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; Cytarabine; Dexamethasone; Dexamethasone acetate; Cyclophosphamide; Methotrexate; Etoposide; Etoposide phosphate; Vincristine; Mitoxantrone; Asparaginase; Mercaptopurine; Vinblastine; Pegaspargase; Teniposide; BB 1101; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents