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NCT Number: NCT01244906

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

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.

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Key information

Conditions

Hematologic Neoplasms Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Prolymphocytic Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northside Hospital

Atlanta, Georgia, 30342, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

allogeneic hematopoietic stem cell transplantation

Procedure

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.

Primary outcomes

  1. Incidence of GVHD

    Time frame: 1 year

    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 outcomes

  1. Incidence of Absolute Neutrophil Count (ANC)/Platelet Engraftment

    Time frame: Approximately Day 30

    To estimate the incidence of neutrophil and platelet engraftment

  2. Number of Participants With Non-Relapse Mortality

    Time frame: 1 year

  3. Number of Patients With Disease Free Survival at 2 Years

    Time frame: 2 years

  4. Number of Patients to Achieve Full Donor Chimerism

    Time frame: 1 year

    Characterize rate of achievement of full donor chimerism

  5. Number of Patients With Overall Survival at 2 Years.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Northside Hospital, Inc.

Other

Collaborators

  • Blood and Marrow Transplant Group of Georgia

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 19, 2010
Registry last updated
May 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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