Phase 2
N=39
Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis
Leukemia · Lymphoma · Myelodysplastic Syndrome · Myelofibrosis · Severe Aplastic Anemia
Bottom Line
View on ClinicalTrials.gov: NCT02065154 ↗Enrolled (actual)
39
Serious AEs
20.5%
Results posted
Jun 2022
Primary outcome: Primary: Grade II-IV Acute GVHD — 30 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cyclophosphamide (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Grade II-IV Acute GVHD |
30 | — |
| SECONDARY Overall Survival |
51 | — |
| SECONDARY Disease-free Survival |
46.15 | — |
| SECONDARY Regimen Related Toxicity |
6 | — |
| SECONDARY Relapse Rate |
21 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02065154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.