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NCT Number: NCT05849207

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

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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Key information

Conditions

Hematologic Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Akil Merchant, MD

SUB_INVESTIGATOR

Alan Kwan, MD

SUB_INVESTIGATOR

Arash Asher, MD

SUB_INVESTIGATOR

Clinical Trial Recruitment Navigator

CONTACT

[email protected]

13104232133

Hannah Lee, MD

SUB_INVESTIGATOR

John Chute, MD

SUB_INVESTIGATOR

Joshua Sasine, MD, PhD

SUB_INVESTIGATOR

Justin Darrah, MD

SUB_INVESTIGATOR

Noah Merin, MD, PhD

SUB_INVESTIGATOR

Philip Chang, MD

SUB_INVESTIGATOR

Robert Vescio, MD

SUB_INVESTIGATOR

Stephen Shiao, MD, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 100 days post-transplant

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

Secondary outcomes

  1. Time to neutrophil and platelet engraftment

    Time frame: 60 days post-transplant

    Days to neutrophil and platelet engraftment since transplant

  2. Non-Relapse mortality

    Time frame: 100 days post-transplant

    Rate of treatment-related mortality

  3. Chronic Graft Versus Host Disease (GVHD) at 1 year

    Time frame: 1-year post-transplant

    • 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.

  4. Relapse

    Time frame: 1-year post-transplant

    Percentage of patients who relapse by year 1

  5. Overall Survival (OS)

    Time frame: 1-year post-transplant

    Overall survival at 1 year

  6. Graft Versus Host Disease (GVHD)-free and Relapse Free Survival

    Time frame: 1-year post- transplant

    Percentage of patients without relapse or GVHD at 1 year

  7. Change in cardiac function

    Time frame: From 60 days prior to transplant to 365 days post-transplant

    Change in cardiac (heart) injury defined by any of an increase in T1 time > 500 ms from pre-transplant imaging, T2 time > 5 ms from pre-transplant imaging, or a decrease in left ventricular ejection fraction > 10% of the original measurement to below 53% from post-transplant imaging.

  8. Change in active daily living

    Time frame: From 60 days prior to transplant to 365 days post-transplant

    Change in function over time as determined by Lawton Activities of Daily Living questionnaire.

    • Patients will choose either 0 or 1 to rate their level of function with 1 being the highest level of function.

  9. Change in function

    Time frame: From 60 days prior to transplant to 365 days post-transplant

    Change in function over time as determined by the Patient-Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief 3-Dimensional Profile.

    • Patients will rate their physical condition and fatigue using an inverse 5-item likert scale where 5 represents the highest level of function or the greatest amount of impact on function.

  10. Change in pain

    Time frame: From 60 days prior to transplant to 365 days post-transplant

    Change in pain over time as determined by the Patient-Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief 3-Dimensional Profile.

    • Patients will rate their level of pain using a scale from 0 to 10 with 10 being the highest level of pain.

  11. Change in physical function

    Time frame: From 60 days prior to transplant to 365 days post-transplant

    Change in lower limb functioning over time as evaluated by the Short Physical performance Battery. (SPPB).

    • Patients will complete a series of tests evaluating balance, speed and standing capabilities. Patients will be rated using a scale of 0 to 12 where a score of less than 10 indicates mobility limitations.

  12. Change in grip strength

    Time frame: From 60 days prior to transplant to 365 days post-transplant

    Change in grip strength as measured using the Jamar dynamometer (device used to measure grip)

  13. Change in cognitive function

    Time frame: From 60 days prior to transplant to 365 days post-transplant

    Change in cognitive function over time using the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognition questionnaire.

    -Patients will rate their cognitive ability on a scale of 1 to 5 with 5 representing the least amount of difficulty.

  14. Change in mental health

    Time frame: From 60 days prior to transplant to 365 days post-transplant

    Change in mental health over time using the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Depression Questionnaire.

    • Patients will rate their level of depression on a scale of 1 to 5 with 5 representing the greatest level of depression.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Navigator

CONTACT

[email protected]

310-423-3713

Sponsors and collaborators

Lead sponsor

Ronald Paquette

Other

Registry information

Official study 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

Acronym: GeriBMT

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 8, 2023
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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