HLA-mismatched unrelated HCT using PTCy

Phase 2

Recruiting

• Conditions: Hematologic malignancy

• Registration Number: JPRN-jRCTs051220057
• Lead Sponsor: Kuno Masatomo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Patients meet all of the following criteria (1-6) :
1) Age >= 16 and <70 years old
2) ECOG Performance Status 0 or 1
3) Normal function of major organs
4) Major Indication
a) AML
Refractory to 1st induction therapy
Relapse after chemotherapy
Unfavorable chromosome abnormality including del(5q)/-5, -7/del(7q), abn 3q, 9q, 11q, 20q, 21q,
17q, t(6;9), t(9;22) or complex karyotype
Normal karyotype and FLT3-ITD mutation
Intermediate/poor group by JALSG score
AML with MRC
History of relapse after allo-HSCT
CR1 with standard risk or high risk
(b) ALL
Refractory to 1st induction therapy, MRD positive or unevaluable
Relapse after chemotherapy
Any of the following poor prognostic factors
i) t(9;22) or t(4;11)
ii) >= 35 years of age at diagnosis
iii) WBC count of more than 30,000/uL for B-ALL, or more than 100,000/uL for T-ALL at diagnosis
History of relapse after allo-HSCT
History of relapse after CAR-T therapy
(c) Acute leukemias of ambiguous lineage
Refractory to the first induction therapy
Relapse after chemotherapy
Unfavorable chromosome abnormality
History of relapse after allo-HSCT
(d) MDS
EB-1 or 2
IPSS intermediate-2 or high
Transfusion dependent
History of relapse after allo-HSCT
(e) CML
AP or BC: refractory to multiple TKIs
CP beyond 1st CP or AP
History of relapse after allo-HSCT
(f) ATLL
Acute or lymphoma type in the SD or better
(g) ML
Malignant lymphoma which is classified in the WHO classification (revised 4th edition) which relapse
after auto-HCT or CAR-T therapy, or which have no indication for auto-HCT or CAR-T therapy due to
no sensitivity to chemotherapy or poorly controlled disease with conventional chemotherapy
(h) The disease which is approved as an indication of allo-HSCT in our conference
5) Patients who have a HLA 1-2 allele-mismatched unrelated donor and have no HLA matched relate
d or unrelated donor
6) Informed consent has been acquired

Exclusion Criteria

1) Major organ dysfunction
a) Total bilirubin: >= 2.0 mg/dl
b) Serum creatinine: >= 2.0 mg/dl
c) Left ventricular ejection fraction: < 50%
d) Pulmonary function test: %VC < 40%, FEV1.0% <50% or SpO2 <90% on room air
e) AST or ALT >= 3 x UNL
2) Uncontrolled active infection
3) Uncontrolled CNS invasion
4) Poorly controlled insulin-treated diabetes mellitus
5) Poorly controlled hypertension
6) Patients with a severe complication including heart failure, coronary failure, acute myocardial infarction within the last three months, liver cirrhosis and uncontrolled interstitial pneumonia
7) Pregnant, lactating woman or woman of childbearing potential
8) Patients with a severe mental disorder who are likely to be unable to participate in the study
9) HIV antibody positivity
10) A history of hypersensitivity or allergy to cyclophosphamide, tacrolimus or mycophenolate mofetil
11) Plan for administration of ATG for conditining or GVHD prophylaxis
12) The physician in charge determines that there is no indication to perform this intervention
(Note: HBs antigen positivity and HCV antibody positivity is not exclusion criterion. The positivity o
f donor-specific antigen (DSA) is not excluded but DSA with MFI >=5000 should be avoided as much
as possible.)

Study & Design

• Study Type: Interventional
• Study Design: Not specified