Clinical trial NCT04118075: PT-CY With or Without Low-dose ATG for Lymphoid Malignancies Undergoing Allo-HSCT
Official title: Post Transplantation Cyclophosphamide With or Without Low-dose ATG for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: GVHD, Acute
Keywords: aGVHD, cGVHD, PT-CY
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 23
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: All patients received Flu-BU-VP16 as myeloablative conditioning followed by cyclophosphamide (D+3 and +4) and subsequent tacrolimus. For patients with unrelated or haplo-donor received low-dose ATG at Day +15.

Detailed description: For patients with high-risk lymphoid malignancies, patients will undergo allo-HSCT from HLA matched sibling, unrelated (9\~10/10) donor or hallo-identical donors. For all patients will receive myeloablative conditioning with 5-day fludarabine, 2-day VP-16 and 3-day busulifan. For prophylaxis graft versus host disease (GVHD), patients will receive cyclophosphamide 50mg/kg daily on D+3 and +4 with subsequent tacrolimus starting at D+5. For patients receiving HSCT from unrelated or haplo-donor, low-dose ATG 2.5mg/kg will be given on Day +15.

Eligibility criteria: Inclusion Criteria:

* patients with lymphoid malignancies: CR1 or CR2 for acute lymphoblastic leukemia; T cell lymphoma (any CR/PR); B cell lymphoma (PR1 or CR2), hodgkin's disease (CR2 or beyond), Sezary syndrome
* patients with HLA matched sibling, unrelated (HLA 9\~10/10 matched) or haplo-identical donor

Exclusion Criteria:

* patients with active infection
* patients with abnormal liver function damage: ALT/AST above 2X normal range
* patients with abnormal renal function damage Scr\>160µmol/L;
* patients with insufficient pulmonary function (FEV1，FVC，DLCO\<50%）and heart failure or with EF \<50%)
* patients with mental instability
* unwilling to give inform consent

Primary outcomes:
measure: grade II-IV acute GVHD
timeFrame: Day 100
Secondary outcomes:
measure: grade III-IV acute GVHD
timeFrame: Day 100
measure: Non relapse mortality (NRM)
timeFrame: Day 100
measure: chronic GVHD (cGVHD)
timeFrame: 1 year
measure: moderate to sever chronic GVHD
timeFrame: 1 year
measure: relapse rate
timeFrame: 1 year
measure: non relapse mortality
timeFrame: 1 year
measure: overall survival
timeFrame: 1 year
measure: GVHD-free relapse free survival (GRFS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Rui Jin Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Jiong Hu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jiang JL, Gao WH, Wang LN, Wan M, Wang L, Hu J. Post-transplantation Cyclophosphamide, Tacrolimus and Low-Dose ATG as GVHD Prophylaxis for Allogeneic Peripheral Stem Cell Transplantation for Adult Patients With Lymphoid Malignancies: A Single Arm Phase II Study. Front Med (Lausanne). 2021 Mar 18;8:630160. doi: 10.3389/fmed.2021.630160. eCollection 2021.