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Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Blood and Marrow Transplant Group of Georgia
Information provided by (Responsible Party):
Northside Hospital, Inc.
ClinicalTrials.gov Identifier:
NCT01244906
First received: November 18, 2010
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hematologic Neoplasms
 Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northside Hospital, Inc.:

Primary Outcome Measures:
  • Incidence of GVHD [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Incidence of Absolute Neutrophil Count (ANC)/Platelet engraftment [ Time Frame: Approximately Day 30 ] [ Designated as safety issue: Yes ]
    To estimate the incidence of neutrophil and platelet engraftment

  • Study outcomes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    To obtain estimates of overall survival (OS), relapse, non-relapse mortality (NRM) and event-free survival (EFS)

  • Assessment of toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Characterize additional hematologic and non-hematologic toxicities associated with this transplant regimen

  • Chimerism [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Characterize rate of achievement of full donor chimerism


Estimated Enrollment: 26
Study Start Date: December 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reduced Intensity Allogeneic Stem Cell Transplantation
All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
 Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244906

Locations
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Northside Hospital, Inc.
Blood and Marrow Transplant Group of Georgia
Investigators
Principal Investigator: Scott R Solomon, MD Blood and Marrow Transplant Group of Georgia
  More Information

Publications:

Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT01244906     History of Changes
Other Study ID Numbers: NSH 911
Study First Received: November 18, 2010
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Northside Hospital, Inc.:
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

Additional relevant MeSH terms:
Neoplasms
Graft vs Host Disease
Hematologic Neoplasms
Immune System Diseases
Neoplasms by Site
Hematologic Diseases
Cyclophosphamide
Mycophenolate mofetil
Sirolimus
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 22, 2013