Stem cells transplant from matched donor in patients with chronic myeloid leukemia who do not improve with TKI therapy

Phase 1

• Conditions: Chronic Myeloid Leukemia; MedDRA version: 18.0Level: LLTClassification code 10054352Term: Chronic phase chronic myeloid leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003126-40-IT
• Lead Sponsor: IVERSITà DEGLI STUDI MILANO BICOCCA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-13
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

-1.Chronic Myeloid Leukaemia -CML- in chronic phase (CP)
2.Failure to achieve at least a Major Cytogenetic Response (MCyR) after a minimum of 18 months of TKIs treatment
3.Inability to tolerate 3 months of uninterrupted full dose TKIs therapy due to hematological toxicity
4.A minimum of three treatment interruptions due to hematological toxicity Availability of a HLA-identical related donor (Matched Related Donor, MRD)
5.Availability of unrelated donor (Matched Unrelated Donor, MUD) satisfying the criteria of a 10/10 antigen match at HLA-A, -B, -C and - DRB1, -DQB1 at high resolution typing, or 9/10 with a permissive – DP disparity according to Fleischhauer model (Crocchiolo et al, Blood 2009)
6.Target graft size (bone marrow):
7.bone marrow: > 3 x 106 CD34+ cells/kg BW recipient
or > 3 x 108 nucleated cells/kg BW

8.Karnofsky Index = 80 %
9.Age =18 and =70 years
10.Adequate contraception in female patients of child-bearing
potential
11.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 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

•1.Secondary malignancies
2.A hematopoietic cell transplantation-specific comorbidity index (Sorror et al Appendix C) > 4
3.Known and manifested malignant involvement of the CNS
4.Active infectious disease
5.Active HIV, HBV or HCV infection
6.Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper normal limit)
7.Impaired renal function (Creatinine-clearance < 60 ml/min; Serum Creatinine > 1.5 x upper normal limit).
8.Pleural effusion or ascites > 1.0 L
9.Pregnancy or lactation
10.Known hypersensitivity to Busilvex and/or fludarabine
11Non-co-operative behaviour or non-compliance
12 Psychiatric diseases or conditions that might impair the ability to give informed consent

Study & Design

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