CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
dexamethasone +18 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01700946
NCT01700946Phase 2Completed
CompareCT.gov

A Phase II Study of Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma

St. Jude Children's Research Hospital·interventional·Posted Oct 4, 2012·Updated Sep 28, 2022

In Brief

A Phase 2 clinical trial evaluating dexamethasone, vincristine sulfate, and 17 other interventions for Recurrent B-Cell Childhood Acute Lymphoblastic Leukemia and Recurrent Childhood B-Lymphoblastic Lymphoma. Completed, enrolled 80 participants across 3 sites.

Detailed Summary

The overall objective of this protocol is to improve the cure rate of relapsed precursor B-cell acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma. This phase II trial is studying risk-directed therapy for B-lymphoblastic leukemia or lymphoma in first relapse. Standard risk (SR) and high risk (HR) participants will receive different therapy. Treatment will consist of chemotherapy for SR participants, and chemotherapy followed by hematopoietic stem cell transplant (HSCT) for HR in first relapse. Induction therapy consists of three blocks of chemotherapy. The first block is a novel immunotherapy regimen that includes chemotherapy, rituximab and infusion of haploidentical natural killer (NK) cells. SR participants will continue to receive chemotherapy for a total duration of approximately 2 years. HR participants will be candidates for HSCT and will proceed to transplant once a suitable donor is found and their minimal residual disease (MRD) is negative.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent B-Cell Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood B-Lymphoblastic Lymphoma
CountriesUnited States
CollaboratorsCookies for Kids' Cancer, Assisi Foundation

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 4, 2012
Enrollment StartApr 15, 2013
Primary CompletionJul 24, 2021
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 13.7 years ago

Interventions

dexamethasonedrug

given intravenously or orally

vincristine sulfatedrug

given intravenously

rituximabbiological

given intravenously

clofarabinedrug

given intravenously

cyclophosphamidedrug

given intravenously

etoposidedrug

given intravenously

aldesleukinbiological

given subcutaneously

pegaspargasedrug

given intravenously

methotrexatedrug

given intrathecally or intravenously

mercaptopurinedrug

given orally

cytarabinedrug

given intrathecally or intravenously

mitoxantronedrug

given intravenously

teniposidedrug

given intravenously

vinblastinedrug

given intravenously

natural killer cell infusionbiological

undergo allogeneic natural killer cell infusion

laboratory biomarker analysisother

correlative studies

therapeutic hydrocortisonedrug

given intrathecally

allogeneic hematopoietic stem cell transplantationprocedure

undergo allogeneic HSCT

CliniMACSdevice

The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.