Salvage therapy with chemotherapy and Natural Killer cells in relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma.

Phase 1

• Conditions: Relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000054-63-ES
• Lead Sponsor: FUNDACION INVESTIGACION BIOMEDICA HOSPITAL NINO JESUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-27
• Last Update Posted: 7 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients betweem 0 and 21 years of age with diagnosis of acute lymphoblastic T leukemia or lymphoma, relapsed or refractary.
2. Lansky index > 60%
3. Left ventricular ejection fraction > 39%
4. Negative HIV serology
Are the trial subjects under 18? yes
Number of subjects for this age range: 6
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with history of bad therapeutical compliance
2. Patients not valid after psycho-social evaluation
3. Severe (4) functional organ disorders (hepatic, renal, respiratory) according to NCI CTCAE v4 criteria
4. Should be considered the contraindications, drug interactions, precautions for use and dose reductions indicated in the corresponding Summary of Product Characteristics (SmPC) (read the SmPC)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified