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

ConditionHematologic Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age65+
SponsorRonald Paquette

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Cyclophosphamide

    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.

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: Open ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum grade acute GVHD by day +100 by Modified Keystone Criteria

Evaluate the frequency of grade III/IV acute GVHD using Modified Keystone Criteria

Time frame
100 days post-transplant

Secondary outcomes

1

Time to neutrophil and platelet engraftment

Days to neutrophil and platelet engraftment since transplant

Time frame
60 days post-transplant
2

Non-Relapse mortality

Rate of treatment-related mortality

Time frame
100 days post-transplant
3

Chronic Graft Versus Host Disease (GVHD) at 1 year

* Rate and severity of patients with chronic GVHD at day 365 post-transplantation. * Chronic GVHD is when the donated stem cells attack the body after 100 days post-transplant. Chronic GVHD is defined by NIH Consensus Criteria for chronic GVHD.

Time frame
1-year post-transplant
4

Relapse

Percentage of patients who relapse by year 1

Time frame
1-year post-transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ronald Paquette

Lead sponsor

Cedars-Sinai Medical Center

Sponsor institution

Source ClinicalTrials.gov
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