Phase 2
Completed N=26
Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant
Hematologic Neoplasms
Source: ClinicalTrials.gov NCT01244906 ↗
Enrolled (actual)
26
Serious AEs
38.5%
Results posted
Mar 2015
Primary outcomePrimary: Incidence of GVHD — 12 participants
Summary
This trial will evaluate the safety and efficacy of post-transplant Cy and sirolimus following reduced intensity allogeneic SCT. It is hoped that the combination of a reduced intensity preparative regimen with a calcineurin-free GVHD prophylaxis regimen will decrease the risk of acute and chronic GVHD, by both limiting mucosal toxicity and augmenting immune reconstitution, thereby improving the safety of the procedure. The past experience with post-transplant Cy suggests that SCT recipients will attain rapid donor T cell chimerism, which the investigators hope will translate into improved disease control through the well documented graft-versus-malignancy effects of donor T cells.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of GVHD |
12 | — |
| SECONDARY Incidence of Absolute Neutrophil Count (ANC)/Platelet Engraftment |
26 | — |
| SECONDARY Number of Participants With Non-Relapse Mortality |
1 | — |
| SECONDARY Number of Patients With Disease Free Survival at 2 Years |
17 | — |
| SECONDARY Number of Patients to Achieve Full Donor Chimerism |
26 | — |
| SECONDARY Number of Patients With Overall Survival at 2 Years. |
19 | — |
Eligibility Criteria
Inclusion Criteria
- Availability of a 7/8 or 8/8 (HLA-A, B, C, DR) related or unrelated donor
- Age 18-75
- One of the following high-risk malignancies
- Chronic Myelogenous Leukemia
- Acute Myelogenous Leukemia
- Myelodysplastic Syndrome
- Myelofibrosis
- Acute Lymphocytic Leukemia
- Acute Lymphoblastic Lymphoma
- Chronic Lymphocytic Leukemia
- Prolymphocytic Leukemia
- Low-grade non-Hodgkin's Lymphoma
- Mantle Cell Lymphoma
- Hodgkin Lymphoma
- Myeloma
Exclusion Criteria
- Poor cardiac function (EF /= 2 mg/dl not due to hemolysis, Gilbert's or primary malignancy)
- Poor renal function (creatinine >/= 2 mg/dl or creatinine clearance <40mL/min)
- Karnofsky status <70%
- HIV positive
Data sourced from ClinicalTrials.gov (NCT01244906). 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.