Phase 3
Completed N=101
Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention
Source: ClinicalTrials.gov NCT01951885 ↗Enrolled (actual)
101
Serious AEs
15.8%
Results posted
Jan 2023
Primary outcomePrimary: Percentage of Severe (Grade 3-4) Mucositis Graded According to the World Health Organization (WHO) Grading Scale — 81.6; 57.4 percentage of participants — p=0.05
◆ Published Evidence
Emerging
10citations · ~3 / year
Tacrolimus/methotrexate vs tacrolimus/reduced-dose methotrexate/mycophenolate for graft-versus-host disease prevention.
Summary
This randomized clinical trial studies standard GVHD prophylaxis with tacrolimus and methotrexate compared to tacrolimus, mycophenolate mofetil and a reduced-dose methotrexate in patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplant. Both mycophenolate mofetil and reduced-dose methotrexate, in combination with a calcineurin inhibitor, have been shown to be safe and effective in GVHD prevention with less toxicity than standard dose methotrexate. It is not yet known, however, whether this combination of mycophenolate mofetil and reduced-dose methotrexate with tacrolimus is more effective than tacrolimus and standard dose methotrexate in preventing GVHD.
Linked Publications
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Tacrolimus/methotrexate vs tacrolimus/reduced-dose methotrexate/mycophenolate for graft-versus-host disease prevention.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Severe (Grade 3-4) Mucositis Graded According to the World Health Organization (WHO) Grading Scale |
81.6; 57.4 | 0.05 |
| PRIMARY Time to Neutrophil Engraftment |
17; 15 | — |
| PRIMARY Time to Platelet Engraftment |
27; 23 | — |
| PRIMARY Cumulative Incidence of Participants With Acute GVHD |
37; 47; 27; 28; 4; 13 | <0.05 sig |
| SECONDARY Length of Hospitalization |
31; 27 | 0.05 |
| SECONDARY Percentage of Participants Using Total Parenteral Nutrition (TPN) Within 100 Days |
41; 38 | <0.05 sig |
| SECONDARY Overall Survival |
71; 72 | <0.05 sig |
| SECONDARY Progression-free Survival |
59; 68 | <0.05 sig |
| SECONDARY Incidence of Chronic GVHD |
25; 36; 20; 23 | — |
| SECONDARY Incidence of Chronic GVHD |
25; 36; 20; 23 | — |
| SECONDARY Length of Time on Continuous Infusion Narcotics |
10; 9 | <0.05 sig |
| SECONDARY Incidence of Infection |
63; 53 | <0.05 sig |
| SECONDARY Incidence of Hepatotoxicity as Measured by Bilirubin |
1.5; 1.1 | <0.05 sig |
| SECONDARY Incidence of Hepatotoxicity as Measured by Elevated Liver Enzymes |
29; 15; 33; 28; 2; 2 | <0.05 sig |
| SECONDARY Incidence of Hepatotoxicity as Measured by Veno-occlusive Disease (VOD) |
8; 2 | <0.05 sig |
| SECONDARY Incidence of Nephrotoxicity |
12; 4; 27; 2 | — |
| SECONDARY Incidence of Pulmonary Toxicity Measured by Pulmonary Hemorrhage |
2; 2 | <0.05 sig |
| SECONDARY Incidence of Pulmonary Toxicity Measured by Pulmonary Edema |
14; 4 | <0.05 sig |
| SECONDARY Incidence of Pulmonary Toxicity Measured by Respiratory Failure |
9; 6 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Patients must have one of the following documented diseases:
- Chronic myelogenous leukemia
- Chronic lymphocytic leukemia
- Multiple myeloma
- Myelodysplasia
- Myeloproliferative disorder
- Non-Hodgkin's lymphoma
- Hodgkin's disease
- Acute myelogenous leukemia
- Acute lymphoblastic leukemia
- Acute biphenotypic leukemia
- Patients must be undergoing a myeloablative allogeneic hematopoietic cell transplant with one of the following conditioning regimens:
- Busulfan (≥ 12.8 mg/kg IV or PO) and cyclophosphamide (≥ 120 mg/kg)
--- Busulfan dose may be adjusted according to pharmacokinetics targeting a daily AUC of 5000 μmol-min/L, per institution standard of practice.
- Total body irradiation (TBI) (≥ 1200 cGy) and etoposide (60 mg/kg)
- TBI (≥ 1200 cGy) and cyclophosphamide (120 mg/kg)
- Patient must have achieved and be in complete morphologic remission prior to starting conditioning regimen
- Patient's donor must be a related or unrelated human leukocyte antigen (HLA) 8/8 allele-level match (HLA-A, B, C and DRB1)
- Adult patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; pediatric patients must have Lansky score ≥ 60%
- Patients must have a life expectancy of 100 days
- Patients must sign written informed consent
Exclusion Criteria
- Patients who have undergone any prior transplant
- Patients who are seropositive for human immunodeficiency virus (HIV)
- Patients with any medical illness or concurrent psychiatric illness which, in the investigators' opinion, cannot be adequately controlled with appropriate therapy
- Patients who are pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT01951885) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.