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Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis

Primary Purpose

Leukemia, Lymphoma, Myelodysplastic Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cyclophosphamide
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Leukemia focused on measuring 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

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UAB Bone Marrow Transplantation and Cellular Therapy Program

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cyclophosphamide (Cytoxan)

Arm Description

Cyclophosphamide (Cytoxan)

Outcomes

Primary Outcome Measures

Grade II-IV Acute GVHD
To calculate the percentage of patients developing graft versus host disease, grade II-IV, in the first 100 days after transplant

Secondary Outcome Measures

Overall Survival
What percentage of participants were alive at a certain time point after transplant
Disease-free Survival
What percentage of participants did not have relapse of disease after transplant
Regimen Related Toxicity
Number of toxicities experienced by the patients in the study
Relapse Rate
What percentage of participants relapsed

Full Information

First Posted
November 5, 2013
Last Updated
September 15, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT02065154
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 27, 2013 (Actual)
Primary Completion Date
April 2022 (Actual)
Study Completion Date
April 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Myelodysplastic Syndrome, Myelofibrosis, Severe Aplastic Anemia, Allogeneic Transplant
Keywords
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyclophosphamide (Cytoxan)
Arm Type
Experimental
Arm Description
Cyclophosphamide (Cytoxan)
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Primary Outcome Measure Information:
Title
Grade II-IV Acute GVHD
Description
To calculate the percentage of patients developing graft versus host disease, grade II-IV, in the first 100 days after transplant
Time Frame
Till 100 days post transplant
Secondary Outcome Measure Information:
Title
Overall Survival
Description
What percentage of participants were alive at a certain time point after transplant
Time Frame
2 Year Post Transplant
Title
Disease-free Survival
Description
What percentage of participants did not have relapse of disease after transplant
Time Frame
1 Year Post-transplant
Title
Regimen Related Toxicity
Description
Number of toxicities experienced by the patients in the study
Time Frame
100 Days Post Transplant
Title
Relapse Rate
Description
What percentage of participants relapsed
Time Frame
2 years post-transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Racquel D Innis-Shelton, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Bone Marrow Transplantation and Cellular Therapy Program
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34288026
Citation
Jamy O, Innis-Shelton R, Bal S, Paluri R, Salzman D, Di Stasi A, Costa L, Meredith R, Lamb L, Minagawa K, Mineishi S, Saad A. Phase II clinical trial of one dose of post-transplant cyclophosphamide for graft versus host disease prevention following myeloablative, peripheral blood stem cell, matched-unrelated donor transplantation. Am J Hematol. 2021 Oct 1;96(10):E396-E398. doi: 10.1002/ajh.26296. Epub 2021 Jul 31. No abstract available.
Results Reference
derived
Links:
URL
http://www.uab.edu/medicine/bonemarrow/
Description
UAB Bone Marrow Transplantation and Cell Therapy Program

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Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis

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