Tocilizumab for the Prevention of Graft Versus Host Disease After Cord Blood Transplantation
Acute Myeloid Leukemia · Acute Lymphoblastic Leukemia · Acute Leukemia · Myelodysplastic Syndromes · Myelodysplastic-Myeloproliferative Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03434730 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Total Body Irradiation (Radiation); Cyclosporine (Drug); Mycophenolate Mofetil (Drug); Tocilizumab (Drug); Filgrastim (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Time in Days to Onset of Grade II-IV aGVHD by Day 100 After Study Treatment |
34 | — |
Summary
Eligibility Criteria
Inclusion Criteria
I. Acute myelogenous leukemia (AML)
- Complete first remission (CR1) at high risk for relapse such as any of the following:
- Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder
- Therapy-related AML
- White cell count at presentation > 100,000
- Presence of extramedullary leukemia at diagnosis
- Any unfavorable subtype by FAB or WHO classification
- High-risk cytogenetics (e.g. those associated with MDS, abnormalities of 5, 7, 8, complex karyotype) or high risk molecular abnormalities
- Requirement for 2 or more induction to achieve CR1
- Any patient with newly diagnosed AML with intermediate risk cytogenetics who elects allograft with curative intent over consolidation chemotherapy
- Any patient unable to tolerate consolidation chemotherapy as would have been deemed appropriate by the treating physician
- Other high risk features not defined above
- Complete second remission (CR2)
- Primary refractory or relapsed AML with less than 10% blasts before transplant. Persistent/relapsed AML with cytogenetic, flow cytometric, or molecular aberrations in >/= 10% of cells are eligible
II. Acute lymphoblastic leukemia (ALL)
- Complete first remission (CR1) at high risk for relapse such as any of the following:
- White cell count at presentation > 30,000 for B-cell lineage and > 100,00 for T-cell lineage
- Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality
- Failure to achieve complete remission after four weeks of induction therapy
- Persistence or recurrence of minimal residual disease on therapy
- Any patient with newly diagnosed ALL >/= 50 years-old
- Any patient unable to tolerate consolidation and/or maintenance chemotherapy as would have been deemed appropriate by the treating physician
- Other high risk features not defined above
- Complete second remission (CR2)
- Primary refractory or relapsed ALL with less than 5% blasts before transplant. Persistent/relapsed ALL with cytogenetic, flow cytometric or molecular aberrations in >/=5% of cells are eligible.
III. Other acute leukemias: leukemias of ambiguous lineage or of other types e.g. blastic plasmacytoid dendritic cell neoplasm with less than 5% blasts. Persistent/relapsed disease with cytogenetic, flow cytometric or molecular aberrations in >/=5% of cells are eligible
IV. Myelodysplastic Syndrome (MDS)/ Myeloproliferative Disorders (MPD) other than myelofibrosis:
- International prognostic scoring system (IPSS) risk score of INT-2 or high risk at the time of diagnosis
- Any IPSS risk category if life-threatening cytopenia(s) exists
- Any IPSS risk category with karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia
- MDS/ myeloproliferative disorder overlap syndromes without myelofibrosis
- MDS/ MPD patients must have less than 10% bone marrow myeloblasts and ANC >/= 0.2 (growth factor supported if necessary) at transplant work-up
V. Non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) at high-risk of relapse or progression if not in remission:
- Eligible patients with aggressive histologies (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell histologies) in CR
- Eligible patients with indolent B cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2nd or subsequent progression with stable disease/CR/PR with no single lesion equal to or more than 5 cm.
- Eligible patients with HL will be without progression of disease (POD) after salvage chemotherapy with no single lesion equal to or more than 5cm.
Organ Function and Performance Status Criteria:
- Karnofsky score >/= 70% (inpatient Leukemia service transfers without discharge are acceptable provided patient has equivalent KPS as if were outpatient)
- Calculated creatinine clearance >/= 60 ml/min
- Bilirubin /= 50% predicted
- Left ventricular eje
Data sourced from ClinicalTrials.gov (NCT03434730). 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.