Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis

Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065154
• Other study ID #: UAB 1286
• Status: Completed
• Phase: Phase 2
• Start date: August 27, 2013
• Est. completion date: April 2022

Study information

• Verified date: September 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allogeneic Transplant
• Anemia, Aplastic
• Leukemia
• Lymphoma
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Myelofibrosis
• Preleukemia
• Primary Myelofibrosis
• Severe Aplastic Anemia

Intervention

Drug:
• Cyclophosphamide

Locations

Country	Name	City	State
United States	UAB Bone Marrow Transplantation and Cellular Therapy Program	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Till 100 days post transplant
Secondary	Overall Survival	What percentage of participants were alive at a certain time point after transplant	2 Year Post Transplant
Secondary	Disease-free Survival	What percentage of participants did not have relapse of disease after transplant	1 Year Post-transplant
Secondary	Regimen Related Toxicity	Number of toxicities experienced by the patients in the study	100 Days Post Transplant
Secondary	Relapse Rate	What percentage of participants relapsed	2 years post-transplant

External Links

•   UAB Bone Marrow Transplantation and Cell Therapy Program