Phase 2
Completed N=48
Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant
Source: ClinicalTrials.gov NCT00691015 ↗Enrolled (actual)
48
Serious AEs
93.6%
Results posted
Jun 2017
Primary outcomePrimary: Incidence of Acute Graft-versus-host Disease (GVHD) — 44.7 percentage of participants
Summary
RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, and antithymocyte globulin before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects of giving sirolimus together with tacrolimus and antithymocyte globulin and to see how well it works in preventing graft-versus-host disease in patients with hematologic cancer who are undergoing donor stem cell transplant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Acute Graft-versus-host Disease (GVHD) |
44.7 | — |
| PRIMARY Severity of Acute Graft-versus-host Disease (GVHD) |
33.3 | — |
| PRIMARY Safety, as Defined by Serious Adverse Events and Adverse Events Related to Study Treatment. |
93.62 | — |
| SECONDARY Incidence of Chronic GVHD. |
44.68 | — |
| SECONDARY Time to Engraftment (i.e., Absolute Neutrophil Recovery [ANC > 500/mm³] ) |
11 | — |
| SECONDARY Overall Survival. |
57.4 | — |
| SECONDARY Incidence of Infections, Including Bacterial, Fungal, and Viral Infections (i.e., CMV and EBV Reactivation, Including Post-transplant Lymphoproliferative Disorders) |
80.85 | — |
| SECONDARY Karnofsky Performance Status Performance Status |
80 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of a hematological malignancy, including any of the following:
- Non-Hodgkin lymphoma in complete remission (CR) or partial remission (PR)
- Hodgkin lymphoma in CR or PR
- Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) meeting either of the following criteria:
- In CR
- Not in CR and meets the following criteria:
- Bone marrow blast 50 mL/min
- Bilirubin 50%
- FVC, FEV\_1, or DLCO > 50% predicted
- Patients on home oxygen not allowed
- Able to cooperate with oral medication intake
- HIV negative
- No active hepatitis B or hepatitis C
- No known contraindication to sirolimus, tacrolimus, or anti-thymocyte globulin
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Data sourced from ClinicalTrials.gov (NCT00691015). 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.