Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis

NCT02065154 | Completed Phase 2 Results DMC

• 1 other identifier: UAB 1286
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall Survival

  2 Year Post Transplant

• Disease-free Survival

  1 Year Post-transplant

• Regimen Related Toxicity

  100 Days Post Transplant

• Relapse Rate

  2 years post-transplant

Study Arms (1)

Cyclophosphamide (Cytoxan)

EXPERIMENTAL

Cyclophosphamide (Cytoxan)

Drug: Cyclophosphamide

Interventions

Cyclophosphamide DRUG

Also known as: Cytoxan

Cyclophosphamide (Cytoxan)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Bone Marrow Transplantation and Cellular Therapy Program

Birmingham, Alabama, 35249, United States

Location

Related Publications (1)

• 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.

  PMID: 34288026 DERIVED

Related Links

• UAB Bone Marrow Transplantation and Cell Therapy Program

MeSH Terms

Conditions

Leukemia; Lymphoma; Myelodysplastic Syndromes; Primary Myelofibrosis; Anemia, Aplastic; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin; Hodgkin Disease

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Myeloproliferative Disorders; Anemia; Bone Marrow Failure Disorders; Leukemia, Myeloid; Leukemia, Lymphoid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, B-Cell

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Omer Jamy
• Organization: UAB

omerjamy@uabmc.edu

205-934-9294

Study Officials

• Racquel D Innis-Shelton, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: February 17, 2014
• Study Start: August 27, 2013
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: September 30, 2022
• Results First Posted: June 15, 2022

Record last verified: 2022-09

Locations

US (1)