Hematologic MalignanciesPhase 1GeriBMTNCT05849207
Post-Transplant Cyclophosphamide in Patients Aged >/= 65 Years Undergoing Haploidentical Transplant
A Phase 1 study testing Cyclophosphamide in people with Hematologic Malignancies, run by Ronald Paquette at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2023to 1 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Clinical Trial Recruitment Navigator, 310-423-5842, GroupCancerTrialInformation@cshs.org
John Chute, MD
About this study
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
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.
Read the 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.
- Conditions
- Hematologic Malignancies
- Being tested
- Cyclophosphamide
- Keywords
- Allogeneic Transplantation
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Open Arm | Experimental | All patients will receive cyclophosphamide on Day +3 and Day +4 following transplant. Receives: Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum grade acute GVHD by day +100 by Modified Keystone Criteria
Evaluate the frequency of grade III/IV acute GVHD using Modified Keystone Criteria
Measured: 100 days post-transplant
Secondary outcomes (14)
Time to neutrophil and platelet engraftment
Days to neutrophil and platelet engraftment since transplant
Measured: 60 days post-transplant
Non-Relapse mortality
Rate of treatment-related mortality
Measured: 100 days post-transplant
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.
Measured: 1-year post-transplant
Relapse
Percentage of patients who relapse by year 1
Measured: 1-year post-transplant
Overall Survival (OS)
Overall survival at 1 year
Measured: 1-year post-transplant
Graft Versus Host Disease (GVHD)-free and Relapse Free Survival
Percentage of patients without relapse or GVHD at 1 year
Measured: 1-year post- transplant
Change in cardiac function
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.
Measured: From 60 days prior to transplant to 365 days post-transplant
Change in active daily living
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.
Measured: From 60 days prior to transplant to 365 days post-transplant
Change in function
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.
Measured: From 60 days prior to transplant to 365 days post-transplant
Change in pain
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.
Measured: From 60 days prior to transplant to 365 days post-transplant
Change in physical function
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.
Measured: From 60 days prior to transplant to 365 days post-transplant
Change in grip strength
Change in grip strength as measured using the Jamar dynamometer (device used to measure grip)
Measured: From 60 days prior to transplant to 365 days post-transplant
Change in cognitive function
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.
Measured: From 60 days prior to transplant to 365 days post-transplant
Change in mental health
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.
Measured: From 60 days prior to transplant to 365 days post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start24 Oct 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Open-label trial De-escalation of post-transplant cyclophosphamide dosing
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ronald Paquette
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ronald Paquette, Cedars-Sinai Medical Center
- Investigators
- Ronald Paquette, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849207
- Sponsor's protocol ID
- IIT2022-03-PAQUETTE-GERIBMT
- Acronym
- GeriBMT
- Status last verified
- Aug 2026
- First submitted
- 13 Apr 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05849207
- Acronym / sponsor ID
- GeriBMT / IIT2022-03-PAQUETTE-GERIBMT
- Conditions
- Hematologic Malignancies
- Keywords
- Allogeneic Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Ronald PaquetteUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label trial De-escalation of post-transplant cyclophosphamide dosing
| Arm | Type | Receives |
|---|---|---|
| Open Arm | Experimental | Drug: CyclophosphamideAll patients will receive cyclophosphamide on Day +3 and Day +4 following transplant. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideCyclophosphamide 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. | Drug | Open Arm |
Primary outcome
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
14 secondary outcomes
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
Change in cognitive function
Time frame: From 60 days prior to transplant to 365 days post-transplant
Change in mental health
Time frame: From 60 days prior to transplant to 365 days post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronald Paquette, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclophosphamide in people with Hematologic Malignancies, run by Ronald Paquette at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Navigator (310-423-5842, GroupCancerTrialInformation@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum grade acute GVHD by day +100 by Modified Keystone Criteria (time frame: 100 days post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.