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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
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.
Cedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGMaximum 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
Time to neutrophil and platelet engraftment
Days to neutrophil and platelet engraftment since transplant
Time frame: 60 days post-transplant
Non-Relapse mortality
Rate of treatment-related mortality
Time frame: 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.
Time frame: 1-year post-transplant
Relapse
Percentage of patients who relapse by year 1
Time frame: 1-year post-transplant
Overall Survival (OS)
Overall survival at 1 year
Time frame: 1-year post-transplant
Graft Versus Host Disease (GVHD)-free and Relapse Free Survival
Percentage of patients without relapse or GVHD at 1 year
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: From 60 days prior to transplant to 365 days post-transplant