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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02409576 |
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Date of registration:
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01/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pilot Study of Expanded , Activated Haploidentical Natural Killer Cell Infusions for Sarcomas
NKEXPSARC |
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Scientific title:
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Pilot Study of Expanded , Activated Haploidentical Natural Killer Cell Infusions for Sarcomas |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02409576 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Dario Campana |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Paediatrics, National University of Singapore |
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Name:
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Bernice Oh |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Paediatrics, National University Hospital |
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Name:
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Bernice Oh Lingzhi, MBBS |
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Address:
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Telephone:
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(65)97739114 |
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Email:
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bernice_lx_oh@nuhs.edu.sg |
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Affiliation:
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Name:
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Bernice Oh |
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Address:
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Telephone:
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(65) 97739114 |
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Email:
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bernice_lx_oh@nuhs.edu.sg |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
A ) NK cell Recipient:
1. Age 0 months to 80 years old.
2. Patients with metastatic, progressive or relapsed EWS, RMS after completing standard
of care therapy who are at high risk of relapse even if they do not have any evidence
of residual disease.
a) For patients without residual disease at the point of study entry, response to NK
cells will be measured by their incidence of relapse as indicated by their 5-year
event free survival. Only patients at high risk of relapse > 70% will be enrolled if
there is no evidence of residual disease.
3. Shortening fraction greater than or equal to 25%. Left ventricular ejection fraction
(LVEF) greater than or equal to 40%
4. Glomerular filtration rate greater than or equal to 60 ml/min/1.73 m2.
5. Pulse oximetry greater than or equal to 92% on room air.
6. Direct bilirubin less than or equal to 3.0 mg/dL (50 mmol/L).
7. Alanine aminotransferase (ALT) is no more than 2 times the upper limit of normal.
8. Aspartate transaminases (AST) is no more than 2 times the upper limit of normal.
9. Karnofsky or Lansky performance score of greater than or equal to 50.
10. Does not have a current pleural or pericardial effusion.
11. Has a suitable adult family member donor available for NK cell donation.
12. Has recovered from all acute NCI Common Terminology Criteria for Adverse Events
(CTCAE) grade II-IV non-hematologic acute toxicities resulting from prior therapy per
the judgment of the PI.
13. At least two weeks since receipt of any biological therapy, systemic chemotherapy,
and/or radiation therapy.
14. Is not receiving more than the equivalent of prednisone 10 mg daily.
15. Not pregnant (negative serum or urine pregnancy test to be conducted within 7 days
prior to enrollment).
16. Not lactating.
B) NK cell Donor:
1. First and second degree relative acceptable.
2. 18 years of age or above.
3. Not lactating.
4. Greater than or equal to 3 of 6 HLA match to recipient.
5. Meets eligibility and suitability criteria for hematopoietic cells donation as per
institutional guidelines.
6. Not pregnant (negative serum or urine pregnancy test to be conducted within 7 days
prior to enrollment).
7. HIV negative. Negative results must be within 60 days prior to enrolment.
Exclusion Criteria:
Failure to meet any of the inclusion criteria.
Age minimum:
N/A
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rhabdomyosarcoma
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Ewing Sarcoma
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Intervention(s)
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Biological: Expanded , Activated NK cells
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Primary Outcome(s)
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Disease response after expanded activated NK cell infusion
[Time Frame: 1 month post-NK cell infusion (and at regular intervals thereafter till a year post-NK cell infusion)]
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Secondary Outcome(s)
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Acute and Chronic GVHD
[Time Frame: Initiation of conditioning until 1 month ( 30 days) post- last dose of IL-2]
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Performance status will be assessed by age-dependent Performances Scores ( Lansky scale or Karnofsky performance scale)
[Time Frame: Initiation of conditioning till 30 days post-NK cell infusion]
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Persistence and phenotype of expanded NK cells in research participants with EWS, RMS and OS.
[Time Frame: 1 month ( 30 days) post- NK cell infusion]
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Toxicity of NK cells infusion (NCI toxicity criteria CTC version 4.0)
[Time Frame: 1 month ( 30 days) post- NK cell infusion]
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Secondary ID(s)
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DSRB 2014/00452
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CTC1400413 (NUH)
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CTC1400412 (KKWCH)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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