Brief Title
Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis
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)
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.
Detailed Description
he 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Grade II-IV Acute GVHD
Secondary Outcome
Overall Survival
Condition
Leukemia
Intervention
Cyclophosphamide
Study Arms / Comparison Groups
Cyclophosphamide (Cytoxan)
Description: Cyclophosphamide (Cytoxan)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
39
Start Date
August 27, 2013
Completion Date
April 2022
Primary Completion Date
April 2022
Eligibility 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.
Gender
All
Ages
19 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Racquel D Innis-Shelton, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02065154
Organization ID
UAB 1286
Responsible Party
Principal Investigator
Study Sponsor
University of Alabama at Birmingham
Study Sponsor
Racquel D Innis-Shelton, MD, Principal Investigator, University of Alabama at Birmingham
Verification Date
September 2022