Post-Transplant Cyclophosphamide in Patients Aged >/= 65 Years Undergoing Haploidentical Transplant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-24

Study Completion Date

2028-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hematologic Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Open-label trial

De-escalation of post-transplant cyclophosphamide dosing

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Arm

All patients will receive cyclophosphamide on Day +3 and Day +4 following transplant.

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No