Post-Transplant Cyclophosphamide in Patients Aged >/= 65 Years Undergoing Haploidentical Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cyclophosphamide.
- Who it may be relevant to
- Registry conditions: Hematologic Malignancies. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
IIT2022-03-Paquette-GeriBMT: A Phase I Study of De-Escalation of Post-Transplant Cyclophosphamide Dosing in Patients Aged >/= 65 Years Undergoing Conditioning With Fludarabine and Total Body Irradiation 800 cGy
Overview
The purpose of this phase 1 study is to determine the optimal dose of the immune suppressive drug, cyclophosphamide, following standard allogeneic stem cell transplant in patients aged \>/= 65 years with hematologic malignancies.
Detailed description
The patients will receive a standard dose, or a reduced amount of the immune suppressive drug, cyclophosphamide, that is routinely administered after the transplant procedure. The following procedures will be performed: cardiac MRI scans and/or transthoracic echocardiogram (TTE); laboratory tests, geriatric assessments and tests to measure strength and stability.
Participation in the study is expected to last up to one year with follow-up visits occurring on Day +30, Day +100, Day +180 and Day +365 following allogenic stem cell transplant.
Interventions
- Drug Cyclophosphamide
Cyclophosphamide will be administered at 50, 40, 32, or 25 mg/k/d intravenous infusion (IV) continuously for two days starting 60-72 hours after transplant.
Primary outcome measures
- Maximum grade acute GVHD by day +100 by Modified Keystone Criteria [Time frame: 100 days post-transplant]
Secondary outcome measures (12)
- Time to neutrophil and platelet engraftment [Time frame: 60 days post-transplant]
- Non-Relapse mortality [Time frame: 100 days post-transplant]
- Chronic Graft Versus Host Disease (GVHD) at 1 year [Time frame: 1-year post-transplant]
- Relapse [Time frame: 1-year post-transplant]
- Overall Survival (OS) [Time frame: 1-year post-transplant]
- Graft Versus Host Disease (GVHD)-free and Relapse Free Survival [Time frame: 1-year post- transplant]
- Change in cardiac function [Time frame: From 60 days prior to transplant to 365 days post-transplant]
- Change in active daily living [Time frame: From 60 days prior to transplant to 365 days post-transplant]
- Change in function [Time frame: From 60 days prior to transplant to 365 days post-transplant]
- Change in pain [Time frame: From 60 days prior to transplant to 365 days post-transplant]
- Change in physical function [Time frame: From 60 days prior to transplant to 365 days post-transplant]
- Change in grip strength [Time frame: From 60 days prior to transplant to 365 days post-transplant]
Eligibility criteria
Inclusion criteria
- Patient age >/= 65 years
- Patient and related Donor (if applicable) sign the Informed Consent Form for the study. If donor is unrelated, donor does not sign Informed Consent Form and this will not affect recipient study eligibility.
- Patient meets standard criteria for allogeneic stem cell transplant
- Patient is deemed suitable to receive Flu/TBI 800 conditioning regimen as standard of care transplant
- Donor is willing to donate peripheral blood stem cells
Exclusion criteria
- Patient has a diagnosis of myelofibrosis
- Patient has high titer antibodies (>10,000 mean fluorescent intensity) against one or more donor HLA antigens
- Patient has undergone prior autologous or allogeneic stem cell transplant
- Requiring sedation for cardiac MRIs.
- Prohibited Implants and/or Devices:
- Mechanical, magnetic or electrical activated implants (i.e. cardiac pacemakers, neurostimulators and infusion pumps)
- Ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial, aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged.
- Subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cedars-Sinai Medical Center — Los Angeles
Identifiers
NCT: NCT05849207 · IIT2022-03-PAQUETTE-GERIBMT