Recruiting PHASE1 Hematologic Malignancies

New treatment option for Hematologic Malignancies

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

ClinicalTrials.gov ID: NCT05849207

What this study is testing

What is Cyclophosphamide?

Cyclophosphamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hematologic malignancies.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 65 and older

You may be able to join if

  • 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...
  • 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

You likely can't join if

  • 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)
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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.
  • people with claustrophobia, problems being in enclosed spaces, or inability to lie supine.

The study team makes the final eligibility decision.

Where it's taking place

  • Los Angeles, California, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.