NCT00995137

Brief Summary

This study will determine the maximum tolerated dose of genetically modified natural killer (NK) cells in research participants with relapsed or refractory B-lineage acute lymphoblastic leukemia (ALL).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

April 26, 2017

Status Verified

February 1, 2015

Enrollment Period

3.6 years

First QC Date

October 14, 2009

Last Update Submit

April 24, 2017

Conditions

Lymphoblastic Leukemia, Acute

Keywords

Relapsed or refractory B-Lineage ALL

Outcome Measures

Primary Outcomes (1)

  • This study will determine the maximum tolerated dose of genetically modified NK cells in research participants with relapsed or refractory B-lineage ALL

    30 days after the enrollment of the last patient

Secondary Outcomes (2)

  • This study will determine the persistence and phenotype of genetically modified NK cells in research participants with relapsed or refractory B-lineage ALL.

    30 days after the enrollment of the last patient

  • This study will explore the efficacy of genetically modified NK cells in research participants with relapsed or refractory B-lineage ALL.

    30 days after the enrollment of the last patient

Study Arms (1)

relapse B-Lineage ALL

EXPERIMENTAL

All patients meeting the eligibility criteria. Intervention: NK Cell Infusion

Biological: NK Cell Infusion

Interventions

NK Cell InfusionBIOLOGICAL

Infusing genetically modified NK cells into research participants who have chemotherapy refractory or relapse B-lineage ALL.

relapse B-Lineage ALL

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age: less than or equal to 18 years of age. May be greater than 18 years of age if currently a St. Jude patient.
  • Patients with relapsed or refractory B-lineage ALL who are not eligible for hematopoietic stem cell transplantation (HSCT) because their leukemia is not in remission (\>5% blasts in bone marrow as evidenced either by morphology or by flow cytometry).
  • Shortening fraction greater than or equal to 25%.
  • Glomerular filtration rate greater than or equal to 50 cc/min/1.73 m2.
  • Pulse oximetry greater than or equal to 92% on room air.
  • Direct bilirubin less than or equal to 3.0 mg/dL.
  • Alanine aminotransferase (ALT) is no more than 2 times the upper limit of normal.
  • Aspartate transaminases (AST) is no more than 2 times the upper limit of normal.
  • Karnofsky or Lansky performance score of greater than or equal to 50.
  • No known allergy to murine products or HAMA testing results within normal limits.
  • No prior receipt of a gene-transfer agent (e.g. retroviral, adenoviral, lentiviral vector).
  • Does not have a current pleural or pericardial effusion.
  • Has a suitable adult family member donor available for NK cell donation.
  • Has recovered from all acute NCI Common Toxicity Criteria grade II-IV non-hematologic acute toxicities resulting from previous therapy as per the judgment of the principal investigator.
  • At least two weeks since receipt of any biological therapy, systemic chemotherapy, and/or radiation therapy.
  • +1 more criteria

You may not qualify if:

  • Pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment)
  • Breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Jude Children's Research Hospital

Memphis, Tennessee, 38105-3678, United States

Location

Related Publications (1)

  • Del Zotto G, Marcenaro E, Vacca P, Sivori S, Pende D, Della Chiesa M, Moretta F, Ingegnere T, Mingari MC, Moretta A, Moretta L. Markers and function of human NK cells in normal and pathological conditions. Cytometry B Clin Cytom. 2017 Mar;92(2):100-114. doi: 10.1002/cyto.b.21508. Epub 2017 Feb 12.

    PMID: 28054442DERIVED

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaRecurrence

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Shook, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2009

First Posted

October 15, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2014

Last Updated

April 26, 2017

Record last verified: 2015-02

Locations

US(1)