Clinical trial · Interventional
Methotrexate and Glucocorticoids in Treating Patients With Newly Diagnosed Acute Graft-Versus-Host Disease After Donor Stem Cell Transplant
A Phase II Study to Evaluate Efficacy and Tolerability of Methotrexate in Combination With Glucocorticoids for the Treatment of Newly Diagnosed Acute Graft-Versus-Host Disease After Nonmyeloablative Hematopoietic Cell Transplantation
- 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)
RATIONALE: Methotrexate and glucocorticoid therapy, such as prednisone or methylprednisolone, may be an effective treatment for acute graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This phase II trial is studying how well giving methotrexate together with glucocorticoids works in treating patients with newly diagnosed acute graft-versus-host disease after donor stem cell transplant.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| methotrexate | Drug | Methotrexate | ALIAS |
| methylprednisolone | Drug | — | UNRESOLVED |
| prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion of patients treated with a methylprednisolone-equivalent glucocorticoid dose ≤ 0.75 mg/kg on day 28 after initiation of systemic glucocorticoid therapy for acute graft-versus-host disease (GVHD)
Secondary outcomes (9)
- measure
- Proportion of patients in whom methotrexate (MTX) had to be discontinued because of toxicity
- measure
- Incidence of severe acute GVHD (grades III or IV)
- measure
- Incidence of extensive chronic GVHD
- measure
- Incidence of secondary systemic immunosuppressive therapy
- measure
- Cumulative corticosteroid use over 1 year
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Newly diagnosed acute graft-versus-host disease (GVHD)
* Has undergone nonmyeloablative allogeneic hematopoietic stem cell transplantation (HSCT) from an HLA-matched related or unrelated donor ≥ 14 days ago
* Treatment of GVHD with glucocorticoids indicated by 1 of the following criteria:
* Initial treatment with prednisone or methylprednisolone at 2 mg/kg indicated (in the judgement of attending physician) by any of the following:
* Severity of GVHD requires hospitalization
* GVHD manifestations include symptoms other than anorexia, nausea, and vomiting
* GVHD begins within 2-3 weeks after HSCT
* GVHD manifestations progress rapidly from 1 day to the next before treatment
* Initial treatment with prednisone or methylprednisolone at 1 mg/kg did not produce adequate clinical improvement within the first 4 days (in the judgement of attending physician)
* No pleural effusion or ascites (i.e., free-flowing fluid by lateral decubitus views)
* Mere blunting of costo-phrenic angles on a posterior anterior chest x-ray is not sufficient
* No GVHD after donor lymphocyte infusion
* No hallmarks of chronic GVHD
* No bronchiolitis obliterans
PATIENT CHARACTERISTICS:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 12 months after completion of study treatment
* No severe mucositis (grade 3 or 4) indicated by erythema, edema, or ulcerations requiring hydration, parenteral nutritional support, or intubation or resulting in aspiration pneumonia
* Absolute neutrophil count ≥ 1,500/mm\^3
* Bilirubin ≤ 2 times upper limit of normal (ULN) (unless abnormality attributable to GVHD)
* AST and ALT ≤ 2 times ULN (unless abnormality attributable to GVHD)
* Creatinine clearance ≥ 50 mL/min
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior prednisone or methylprednisolone at 2 mg/kg for \> 72 hours or at 1 mg/kg for \> 96 hours
* Concurrent topical therapy, including psoralen and ultraviolet A irradiation (PUVA), glucocorticoid creams, oral beclomethasone dipropionate, topical azathioprine, or ophthalmic glucocorticoids allowed
* No other concurrent treatment for GVHDReferences
Publications (0)
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