Percentage of B Cells at One Year Post-transplant in Participants Who Did/Did Not Receive Leuprolide Following Bone Marrow Transplant (BMT)
| Group | Value (percentage of cells) |
|---|---|
| Transplant Recipient | 22.1 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation
NCT0133898719 Apr 2011 to 19 Nov 2020
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Background: * One way to treat certain cancers of the blood and immune system is to give a patient stem cells from the bone marrow of a donor whose genes are very similar but not identical to the patients. One problem with these transplants is that the new immune cells may not work as well in the recipient as they did in the donor. The result may be that the immune system will not work as well. This can increase the risk of severe infections and other complications. * Researchers are studying the use of drugs that lower hormone levels and may allow the immune system to recover in a way that improves white blood cell function. In this study they will be looking at the drug leuprolide, a drug that lowers estrogen or testosterone levels, to see if it might improve the function of the newly transplanted cells. Objectives: * To determine whether leuprolide improves immune system function after bone marrow transplant from a donor with similarities in their immune cells (matched to each other). * To evaluate the effectiveness of a nuclear medicine test with a radiotracer drug 3-deoxy-3 18F-fluorothymidine (FLT) in imaging studies. FLT will be used to image the immune system function in patients who have received bone marrow from the donor. Eligibility: * People between 15 (or as young as 9 in those who have gone through puberty) and 55 years of age. These patients must have acute myelogenous leukemia, acute lymphocytic leukemia, high-risk myelodysplastic syndrome, chronic myelomonocytic leukemia, or chronic myeloid leukemia. They must also be eligible for a bone marrow transplant. * Genetically similar donors for the patients who are eligible for a transplant. Design: * People taking part in the study will be screened with a physical examination, medical history, blood and urine tests, and imaging studies. Patients who are not in remission or who require a bone marrow donor search may receive chemotherapy first. * Donors will provide bone marrow for transplant according to standard bone marrow transplant (BMT) procedures. * All women and half of the men will receive regular leuprolide doses 2 weeks before BMT to suppress hormone function. * All recipients will receive 4 days of radiation followed by 2-4 days of chemotherapy before the bone marrow transplant (depending on age). Recipients will also receive other drugs to prevent transplant rejection and other complications of transplantation. * Recipients will be monitored in the hospital for 4 weeks after transplant with blood tests and other studies. * Some recipients will have an imaging study with FLT during the protocol. These imaging studies will take place before the transplant, on days 5 and 28 after transplant, and at a later time to be determined by the study researchers. * Following discharge, participants will be monitored closely for up to 6 months, with regular but less frequent followup visits for at least 5 years. Study-related medications, including vaccinations for the new immune system, will be provided by the National Institutes of Health during the hospital stay and after discharge.
Active comparator
Arm1 First Transplt/males/leuprolide/+/-FLT Imaging
Males randomized to leuprolide for first transplant. \[18F\]fluorothymidine (FLT) imaging
Active comparator
Arm2 First Transplt/males/No Leuprolide/+/- FLT Imaging
Males not receiving leuprolide for first transplant \[18F\]fluorothymidine (FLT) imaging
Experimental
Arm3 First Transplt/females/leuprolide+/- FLT Imaging
Females receiving leuprolide for first transplant. \[18F\]fluorothymidine (FLT) imaging
Experimental
Arm4-Second Transplt/leuprolide and FLT Imaging
Second transplant with leuprolide and \[18F\]fluorothymidine (FLT) imaging
No intervention
Healthy Volunteer - Arm 5
Healthy Volunteer
Outcomes the sponsor listed as primary.
Percentage of B Cells at One Year Post-transplant in Participants Who Did/Did Not Receive Leuprolide Following Bone Marrow Transplant (BMT)
Time frame · after first Bone Marrow Transplant, approximately 12 months post-transplant
B cell percentage is defined as the percentage of lymphocytes that are B cells.
Time to Engraftment in First Transplant Recipients Only With Median Thoracic Spine Standardized Uptake Values (SUV) of 1.4 or Greater Than Those Patients With SUV's Less Than 1.4
Time frame · 18F FLT scan done between days +5 to +12 and then time from that scan to engraftment measured
18F-FLT imaging was performed serially on patients post transplant to identify the level of uptake of 18F-FLT at a day +5 to +12 scan and the day at which neutrophils recover to \>500 (i.e., subclinical bone-marrow recovery within 5 days of Bone Marrow Transplantation (BMT infusion)). On each image for each patient, the region of interest was drawn within each thoracic medullary space (n=12), generating the SUV for each space. The mean of these was calculated for each scan. The analysis was the median of the means of the SUV of the thorax values of the day 5-12 scan (averaged the SUV of the thorax for each patient and then took the medians of these).
Number of Adverse Events Related to Study Drug Experienced by Participants After Second Bone Marrow Transplant (BMT)
Time frame · 12 months after second BMT
Serious and non-serious adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Time frame · Date treatment consent signed to date off study, approximately 79 months and 11 days.
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of cells) |
|---|---|
| Transplant Recipient | 22.1 |
| Group | Value (Days) |
|---|---|
| Transplant Recipient | 5 |
| Group | Value (Adverse Events) |
|---|---|
| Transplant Recipient - 2nd Bone Marrow Transplant | 0 |
| Group | Value (Participants) |
|---|---|
| Males That Did Not Receive Leuprolide for 1st Transplant | 10 |
| Males Randomized to Receive Leuprolide for 1st Transplant | 8 |
| Females That Received Leuprolide for 1st Transplant | 20 |
| Matched Related Donors for Transplant | 4 |
| Recipients of 2nd Transplant | 2 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Males That Did Not Receive Leuprolide for 1st TransplantMales undergoing first transplant who did not receive leuprolide. | 4 / 10 | 5 / 10 | 10 / 10 |
| Males Randomized to Receive Leuprolide for 1st TransplantMales undergoing first transplant who were randomized to receive leuprolide. | 3 / 8 | 6 / 8 | 8 / 8 |
| Females That Received Leuprolide for 1st TransplantFemales undergoing first transplant who all received leuprolide. | 8 / 20 | 15 / 20 | 20 / 20 |
| Matched Related Donors for TransplantIndividuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic bone marrow transplant on this study. | 0 / 31 | 2 / 31 | 4 / 31 |
| Recipients of 2nd TransplantPatients receiving second allogeneic bone marrow transplant on this study. | 2 / 2 | 2 / 2 | 2 / 2 |
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