PTCy and tacrolimus for GVHD prevention after allo-HCT from HLA matched donor

JRCT ID: jRCTs051180143

Registered date:20/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hematological malignancy
• Date of first enrollment: 20/10/2016
• Target sample size: 39
• Study type: Interventional
• Intervention(s): Cy is intravenously administered at 50mg/kg/day on days 3 and 4. Continuous intravenous infusion of Tac is started at 0.03mg/kg/day from day 5. Unless GVHD developed, Tac was tapered from day 60-100 and stopped until day 180.

Outcome(s)

• Primary Outcome: 1 year chronic GVHD cumulative incidence

Secondary Outcome

1) Overall survival, relapse rate
2) Non-relapse mortality
3) GVHD and relapse-free survival: GRFS
4) Incidence of primary and secondary engraftment failure
5) Time to hematopoietic recovery, time to complete donor chimerism
6) Incidence and severity of acute and chronic GVHD
7) Regimen related toxicity
8) Incidence of bacterial, fungal and viral infections
9) Immune reconstruction

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: < 70age old
• Gender: Both

Include criteria

(1) Disease
(a) AML
(b) ALL
(c) Acute leukemias of ambiguous lineage
(d) MDS
1. IPSS int-2 or high, or IPSS-R intermediate, poor or very poor
2. Transfusion dependent MDS (more than 2 unit RBC or 10 unit platelet weekly transfusion)
(e) CML
1. CP beyond 1st CP
2. TKI failure in 1st CP
(f) malignant lymphoma
1. Indolent lymphoma after 1st relapse/progression
2. Aggressive lymphoma
*Chemo-refractory lymphoma after 1st relapse, or
*Lymphoma after 2nd relapse, or
*relapsed Lymphoma after auto-HCT
(g) Other, hematological malignancy that was judged as necessity of allo-HCT in our conference

(2) Age >=15 and < 70 years old
(3) ECOG PS 0 or 1
(4) Normal function of major organs
(5) donor: presence of available sibling or unrelated donor with HLA-A, B, C, and DRB1 allele 8/8 match in GVH direction
(Note: no limitation for conditioning regimen intensity)

Exclude criteria

1) Major organ dysfunction
a) Total bilirubin:>= 2.0mg/dl
b) Serum creatinine: >= 2.0mg/dl
c) Ejection fraction: < 50 %
d) Pulmonary function test: %VC <40%, FEV1.0% <50% or SaO2 <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, liver failure, acute myocardial infarction within the last three months, liver cirrhosis and interstitial pneumonia
7) Pregnant, lactating or possible fertile women who may become pregnant
8) Patients with a severe mental who are likely to be unable to participate in the study

9) A history of hypersensitivity or allergy to any drugs in the conditioning regimen of this transplant
10) HIV antibody positivity
11) The administration of ATG is scheduled in conditioning regimen.
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.)

Related Information

• Primary Sponsor: Nakamae Hirohisa
• Secondary Sponsor: Hino Masayuki
• Secondary ID(s): UMIN 000023890