Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis

NCT ID: NCT02065154

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-27
• Study Completion Date: 2022-04-30

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.

Conditions

Leukemia; Lymphoma; Myelodysplastic Syndrome; Myelofibrosis; Severe Aplastic Anemia; Allogeneic Transplant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cyclophosphamide (Cytoxan)

Cyclophosphamide (Cytoxan)

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

Interventions

Cyclophosphamide

Intervention Type: DRUG

Other Intervention Names

Cytoxan

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Omer Jamy

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Racquel D Innis-Shelton, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB Bone Marrow Transplantation and Cellular Therapy Program

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34288026 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://www.uab.edu/medicine/bonemarrow/

UAB Bone Marrow Transplantation and Cell Therapy Program

Other Identifiers

UAB 1286

Identifier Type: -

Identifier Source: org_study_id