Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma (HNJ-NKAES-2012)

December 19, 2016 updated by: Antonio Perez-Martinez, Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma.

To determine safety profile of immunotherapy with natural killer cells and activated expanded (NKAEs) after salvage chemotherapy in relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Pediatric Hematology-Oncology; Hospital Infantil Universitario La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged between 0 and 21 years with relapsed or refractary acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
  • Lansky Index > 60%.
  • Left ventricular ejection fraction > 39%.
  • Negative HIV serology.
  • Provide informed consent in accordance with current legislation.

Exclusion Criteria:

  • Patients with a history of poor compliance.
  • Patients not valid after psycho-social evaluation
  • Severe (4) functional organ disorders (hepatic, renal, respiratory) according to NCI CTCAE v3 criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Activated natural killer cells
Biological: Expanded haploidentical natural killer cells (NKAEs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety profile (number of AEs per patient)
Time Frame: Two months
Two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections
Time Frame: During 14 months
During 14 months
time to hematological recovery (days)
Time Frame: 2 months
hematological recovery: neutrophils >500/mm3, lymphocytes >250/mm3 and platelets >50.000/mm3)
2 months
days of hospitalization in each cycle
Time Frame: 2 months
2 months
Objective response rate
Time Frame: 2 months
Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR)
2 months
days of isolation
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Investigators

  • Principal Investigator: Antonio Pérez-Martínez, MD, PhD, Service of Pediatric Hematology-Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 13, 2013

First Submitted That Met QC Criteria

September 13, 2013

First Posted (Estimate)

September 18, 2013

Study Record Updates

Last Update Posted (Estimate)

December 20, 2016

Last Update Submitted That Met QC Criteria

December 19, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNJ-NKAES-2012
  • 2012-000054-63 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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