Clinical trial NCT01244906: Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant
Official title: A Phase II Trial of Post-Transplant Cyclophosphamide and Sirolimus for Graft-versus-host Disease (GVHD) Prophylaxis Following Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hematologic Neoplasms
Keywords: 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
Lead sponsor: Northside Hospital, Inc.
Sponsor class: OTHER
Collaborators: name: Blood and Marrow Transplant Group of Georgia
First posted: 2010-11-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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 \<40%)
* Poor pulmonary function (FEV1 and FVC \<50% predicted)
* Poor liver function (bilirubin \>/= 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

Primary outcomes:
measure: Incidence of GVHD
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of Absolute Neutrophil Count (ANC)/Platelet Engraftment
timeFrame: Approximately Day 30
measure: Number of Participants With Non-Relapse Mortality
timeFrame: 1 year
measure: Number of Patients With Disease Free Survival at 2 Years
timeFrame: 2 years
measure: Number of Patients to Achieve Full Donor Chimerism
timeFrame: 1 year
measure: Number of Patients With Overall Survival at 2 Years.
timeFrame: 2 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
Study officials:
affiliation: Blood and Marrow Transplant Group of Georgia
name: Scott R Solomon, MD
role: PRINCIPAL_INVESTIGATOR
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