Phase I/IIa clinical trial on the safety and preliminary efficacy of donor-derived anti-leukemia cytotoxic T lymphocytes for the prevention of leukemia relapse in children given haploidentical hematopoietic stem cell transplantatio

Phase 1

• Conditions: eukemia relapse prevention given haploidentical hematopoietic stem cell transplantation; MedDRA version: 21.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003362-41-IT
• Lead Sponsor: FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-07
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1) Age inferior or equal to 18 years and superior or equal to 1 months
2) Life expectancy > 12 weeks
3) Patients affected by life-threatening acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) with high risk of relapse after HSCT, namely:
Patients affected by ALL:
- in first morphological remission but with a positive minimal residual disease = 1 x 10-3 before HSCT;
- in second morphological remission after a high-risk relapse (patients belonging to the S3-S4 BFM risk group), independently of the level of minimal residual disease;
- in second morphological remission with any positivity of minimal residual disease before HSCT;
- in third or subsequent morphological remission, independently of the level of minimal residual disease;
- patients not in morphological remission at time of HSCT.
Patients affected by AML:
- in first morphological remission and with a flow cytometry MRD at the end of induction therapy = 0.1%;
- in first morphological remission and with high-risk disease according to cytogenetics aberrations;
- in first morphological remission after a primary induction failure;
- in second morphological remission;
- in third or subsequent morphological remission;
- patients not in morphological remission at time of HSCT.
4) Pre-HSCT Lansky / Karnofsky score = 40%.
5) HIV negativity.
6) Written informed consent signed by the parents or legal guardians (in case of patients < 18 years) or by the patients (in the case of patients = 18 years).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Ongoing active superior or equal to grade II acute GvHD or chronic extensive GvHD due to a previous allograft
2) Current clinically active infectious disease (including positive HIV serology or viral RNA)
3) Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction <40%)
4) Liver dysfunction (AST/ALT superior or equal to 3 times institutional upper limit normal value –ULN- or bilirubine > 3 times ULN)
5) Renal dysfunction: serum creatinine > 1.5 times ULN or calculated creatinine clearance < 60 ml/min/1.73 m2
6) End stage irreversible multi-system organ failure.
7) Other active malignancy.
8) Pregnant or breast feeding female patient
9) Lack of parents’/guardian’s written informed consent for minors or lack of written informed consent for patients aged 18 y.

Study & Design

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