PT-CY With or Without Low-dose ATG for Lymphoid Malignancies Undergoing Allo-HSCT

S

Shanghai Jiao Tong University School of Medicine

Status and phase

Completed
Phase 2

Conditions

GVHD, Acute

Treatments

Drug: PT-CY-FK +/-ATG

Study type

Interventional

Funder types

Other

Identifiers

NCT04118075
RJH-Lym-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 patients

Sex

All

Ages

16 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 1 patient group

PT-CY-FK +/- ATG
Experimental group
Description:
GVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation.
Treatment:
Drug: PT-CY-FK +/-ATG

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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