Status:
ACTIVE_NOT_RECRUITING
"Phase I / II Study on Infusion of Natural Killer Cells After Haploidentical Transplantation in Pediatric Patients"
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Conditions:
High-risk Leukemias
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
PHASE2
Brief Summary
Phase I / II study on infusion of alloreactive or stimulated Natural Killer cells with IL-15 ex vivo after haploidentical transplantation of hematopoietic progenitors in pediatric patients with hemato...
Detailed Description
Haploidentical hematopoietic stem cell transplantation (haploTPH) constitutes a highly complex but effective procedure for some hematologic malignancies high-risk pediatric patients in the absence of ...
Eligibility Criteria
Inclusion
- Patients of both sexes with age ≤ 21 years.
- Not having an identical HLA donor (family or non-family) available in the time needed for the donation of hematopoietic parents.
- Having a haploidenic donor available
- Diagnosis of high-risk hematological malignancy. This includes:
- i. High risk ALL in first complete remission (RC1);
- ii. ALL in second complete remission (RC2);
- iii. ALL in third complete remission (RC3) or later;
- iv. High risk AML in RC1;
- v. AML in RC2 or later;
- vi. Relapsed AML with \<25% blasts in bone marrow;
- vii. AML related to previous treatments in CR\> 12 months;
- viii. Primary or secondary myelodysplastic syndrome
- ix. NK cell leukemia, biphenotypic or undifferentiated in RC1 or later,
- x. Chronic myeloid leukemia (CML) in accelerated phase, in chronic phase with persistent molecular positivity, or with intolerance to tyrosine kinase inhibitors
- xi. Hodgkin's lymphoma in RC2 or later after failure of autologous TPH, or unable to mobilize hematopoietic progenitors for autologous TPH
- xii. Non-Hodgkin's lymphoma in RC2 or later after failure of autologous TPH, or unable to mobilize hematopoietic progenitors for autologous TPH
- xiii. Myelomonocytic juvenile leukemia.
- Positive pre-transplant evaluation
- i. Left ventricular ejection fraction \> 40% or shortening fraction ≥ 25%;
- ii. Creatinine clearance (ACr) or glomerular filtration rate (TFG) ≥ 50 ml/min/1.73 m2
- iii. Forced Vital Capacity (FVC) ≥ 50% of predicted value or pulse-oximetry ≥ 92% if the patient cannot perform the pulmonary function tests;
- iv. Karnofsky or Lansky Index (depending on the patient's age) ≥ 50;
- v. Bilirubin ≤ 3 times the upper limit of normal for age
- vi. Alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal for age
- vii. Women who are not breastfeeding.
- viii. No uncontrolled bacterial, fungal, or viral infections at the time of inclusion.
- Women of childbearing potential must have a negative serum or urine pregnancy test performed within 14 days prior to trial inclusion and must agree to use highly effective contraceptive methods (diaphragms plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method of contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence, or partner with vasectomy) during study participation and for six months after the last trial visit. In the case of male patients with reproductive capacity, they must commit to using an appropriate barrier method for the duration of the study and for up to 6 months thereafter
Exclusion
- Patients with an active infectious process or other serious underlying medical condition
- Patients who, according to the investigator's criteria, have a history of poor compliance with therapy.
- Patients who after a psycho-social evaluation are advised as not suitable for the procedure:
- i. Social-family situation that makes correct participation in the study impossible.
- ii. Patients with emotional or psychological problems secondary to the illness such as post-traumatic stress disorder, phobias, delusions, psychosis, with the need for support from specialists.
- iii. Evaluation of the involvement of family members in the health of the patient
- Inability to understand the information about the trial
- Received an investigational drug within 30 days prior to the start of therapy or within 5 half-lives of receiving an investigational drug, whichever is longer.
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05304754
Start Date
November 30 2020
End Date
July 1 2026
Last Update
April 6 2025
Active Locations (10)
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1
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
2
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
3
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
4
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007