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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Arm | Experimental | All patients will receive cyclophosphamide on Day +3 and Day +4 following transplant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum grade acute GVHD by day +100 by Modified Keystone Criteria | Evaluate the frequency of grade III/IV acute GVHD using Modified Keystone Criteria | 100 days post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Time to neutrophil and platelet engraftment | Days to neutrophil and platelet engraftment since transplant | 60 days post-transplant |
| Non-Relapse mortality | Rate of treatment-related mortality |
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Inclusion Criteria:
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:
Subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Navigator | Contact | 310-423-3713 | GroupCancerTrialInformation@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Ronald Paquette, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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Open-label trial
De-escalation of post-transplant cyclophosphamide dosing
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| 100 days post-transplant |
| Chronic Graft Versus Host Disease (GVHD) at 1 year |
| 1-year post-transplant |
| Relapse | Percentage of patients who relapse by year 1 | 1-year post-transplant |
| Overall Survival (OS) | Overall survival at 1 year | 1-year post-transplant |
| Graft Versus Host Disease (GVHD)-free and Relapse Free Survival | Percentage of patients without relapse or GVHD at 1 year | 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. | 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. | 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. | 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. | 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. | 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) | 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. | 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. | From 60 days prior to transplant to 365 days post-transplant |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |