Individualized dosing of fludarabine during innate allo SCT: A randomized phase II study (TARGET Study)

Phase 1

• Conditions: AML, MDS, ALL, CML, CLL, NHL, HL, or a myeloproliferative disease (MPD); MedDRA version: 21.0Level: LLTClassification code 10000835Term: Acute leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10008948Term: Chronic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10068361Term: MDSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.0Level: HLGTClassification code 10025321Term: Lymphomas non-Hodgkin's T-cellSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.0Level: PTClassification code 10077465Term: Myeloproliferative neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-000356-18-NL
• Lead Sponsor: niversity Medical Center utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-23
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

1.Adults (> 18 years)
2.AML, MDS, ALL, CML, CLL, NHL, HL, or a myeloproliferative disease (MPD)
3.Indication for allo-SCT according to the policy of the local center
4.WHO performance status = 2
5.Written informed consent

Are the trial subjects under 18? no
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 98
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 98

Exclusion Criteria

1.Relapse of disease within 5 months after previous allo-SCT
2.Bilirubin and/or transaminases > 2.5 x normal value*
3.Creatinine clearance < 40 ml/min*
4.Cardiac dysfunction as defined by:
-Unstable angina or unstable cardiac arrhythmias
-NYHA classification > II (Appendix B)
-Cardiac symptoms and/or history of cardiac disease AND a cardiac ejection fraction < 45%
5.Active, uncontrolled infection

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective is to address whether the individualized fludarabine conditioning reduces the incidence of severe viral infections at day 100 within the context of an aßTCR / CD19 depleted transplantation regimen. ;Secondary Objective: Secundary objective is to address whether the individualized fludarabine conditioning affects other clinical transplantation-related parameters, variations in individual fludarabine exposures and immunological reconstitution after an alpha/beta TCR/CD19 depleted stem cell transplantation.;Primary end point(s): Cumulative incidence of severe viral infections (> grade 2) until day 100;Timepoint(s) of evaluation of this end point: 100 days post alloSCT