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Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis

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ClinicalTrials.gov Identifier: NCT02065154
Recruitment Status : Active, not recruiting
First Posted : February 17, 2014
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Racquel Innis-Shelton, MD, University of Alabama at Birmingham

Brief Summary:
The main purpose of this study is to assess the effects of cyclophosphamide (cytoxan) in the post transplant setting to prevent onset of acute graft-versus-host disease (GVHD). The primary objective is to determine the incidence of grade II-IV acute GVHD following Allogeneic (allo) Hematopoeitic Cell Transplant (HCT) using post-transplant cyclophosphamide (cytoxan) for patients with human leukocyte antigen (HLA) matched unrelated (MUD) and mismatched unrelated (MMUD) donors. Other objectives for this study will be the determination of disease-free survival (DFS) and overall survival (OS) following allo HCT and assess the safety of post-transplant cyclophosphamide (cytoxan) for MUD and MMUD transplantation. Disease recurrence and time to recurrence in patients receiving post-transplant cyclophosphamide compared to historical control without post-transplant cyclophosphamide (cytoxan) will also be evaluated. Other objectives will be to determine the time of onset, severity, responsiveness to treatment, organs involved of acute and chronic GVHD as well as observation of Immune Reconstitution over time.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Myelodysplastic Syndrome Myelofibrosis Severe Aplastic Anemia Allogeneic Transplant Drug: Cyclophosphamide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase II Clinical Trial of the Use of Post-Transplant Cyclophosphamide for Graft Versus Host Disease (GvHD) Prophylaxis Following Matched Unrelated Donor (MUD) and Mismatched Unrelated Donor (MMUD)Hematopoietic Stem Cell Transplant (HSCT)
Actual Study Start Date : August 27, 2013
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021


Arm Intervention/treatment
Experimental: Treatment
Cyclophosphamide (Cytoxan)
Drug: Cyclophosphamide
Other Name: Cytoxan




Primary Outcome Measures :
  1. Grade II-IV acute GVHD [ Time Frame: Assessed 1 time per week until 100 days post transplant. Then assessed 1 time per month until 1 year post transplant. ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 1 Year Post Transplant ]
  2. Disease-free Survival [ Time Frame: 1 Year Post-transplant ]
  3. Regimen Related Toxicity [ Time Frame: 100 Days Post Transplant ]
    Regimen Related Toxicity will be assessed for incidence within the first 100 days of transplant.

  4. Immune Reconstitution [ Time Frame: Days +30, +100, +18-, +365. And as clinically indicated. ]
    The rate and pattern of recovery of total lymphocytes, T cell subsets, B cells, and NK calls are evaluated by flow cytometry and are quantified and reported as percentages of total cell counts.

  5. Relapse Rate [ Time Frame: 2 years post-transplant ]
    Relapse rate will be assessed at 2 years post-transplant



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Disease Criteria: patients must meet diagnostic criteria of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma (HL), myelodysplastic syndrome (MDS), myelofibrosis, or severe aplastic anemia. Patients will be allowed on study if they are deemed eligible for allo HCT regardless of remission status.
  • Age Criteria: 19 to 65 years in age.
  • Organ Function Criteria: All organ function testing should be done within 28 days of study registration.
  • Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram.
  • Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (diffusing capacity of the lung for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted.
  • Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula:

CrCl=(140-age) x weight(kg) x 0.85 (if female)/72 x serum creatinine (mg/dL)

  • Hepatic:

    • Serum bilirubin 1.5 upper limit of normal (ULN)
    • Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN
    • Alkaline phosphatase 2.5 ULN
  • Performance status: Karnofsky ≥ 70%.,
  • Patient must be informed of the investigational nature of this study in accordance with institutional and federal guidelines and have the ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the study.
  • Patient has a suitable and willing HLA-8/8 matched or 6/8 mismatched (at one allele) unrelated donor identified.

Exclusion Criteria:

  • Non-compliant to medications.
  • No appropriate caregivers identified.
  • HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive
  • Uncontrolled medical or psychiatric disorders.
  • Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration.
  • Active central nervous system (CNS) leukemia.
  • Preceding allogeneic HSCT.
  • Pregnancy or Breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065154


Locations
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United States, Alabama
UAB Bone Marrow Transplantation and Cellular Therapy Program
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Racquel D Innis-Shelton, MD University of Alabama at Birmingham

Additional Information:
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Responsible Party: Racquel Innis-Shelton, MD, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02065154     History of Changes
Other Study ID Numbers: UAB 1286
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Keywords provided by Racquel Innis-Shelton, MD, University of Alabama at Birmingham:
acute myeloid leukemia
AML
acute lymphoblastic leukemia
ALL
chronic myeloid leukemia
CML
chronic lymphocytic leukemia
CLL
non-Hodgkin lymphoma
NHL
Hodgkin lymphoma
HL
myelodysplastic syndrome
MDS
myelofibrosis
severe aplastic anemia
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Preleukemia
Myelodysplastic Syndromes
Primary Myelofibrosis
Anemia, Aplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Anemia
Hematologic Diseases
Bone Marrow Diseases
Precancerous Conditions
Myeloproliferative Disorders
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists