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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Hematologic Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of GVHD

Outcome Description:

To estimate the incidence of graft-versus-host disease (GVHD) when utilizing post-transplant cyclophosphamide (Cy) and sirolimus for GVHD prophylaxis following reduced intensity allogeneic hematopoietic stem cell transplantation (SCT) in patients with high risk hematologic malignancies.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Scott R Solomon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Blood and Marrow Transplant Group of Georgia

Authority:

United States: Food and Drug Administration

Study ID:

NSH 911

NCT ID:

NCT01244906

Start Date:

December 2010

Completion Date:

March 2014

Related Keywords:

  • Hematologic Neoplasms
  • 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
  • Neoplasms
  • Graft vs Host Disease
  • Hematologic Neoplasms

Name

Location
Northside Hospital Atlanta, Georgia  30342