Clinical trial · Interventional
PT-CY With or Without Low-dose ATG for Lymphoid Malignancies Undergoing Allo-HSCT
Post Transplantation Cyclophosphamide With or Without Low-dose ATG for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation
NCT04118075CI-TRIAL-00051939completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GVHD, Acute | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PT-CY-FK +/-ATG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PT-CY-FK +/- ATG
- description
- GVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation.
- interventionNames
- Drug: PT-CY-FK +/-ATG
Primary outcomes (1)
- measure
- grade II-IV acute GVHD
- timeFrame
- Day 100
- description
- cumulated incidence of grade II-IV aGVHD
Secondary outcomes (8)
- measure
- grade III-IV acute GVHD
- timeFrame
- Day 100
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDJiang 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. PMID 33816524