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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00080399 | Other Identifier | JHMIRB | |
| P01CA015396 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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To see if it is possible to use short-duration tacrolimus after a peripheral blood stem cell transplant in certain malignancies that are considered difficult to engraft.
The main goal is to learn whether a drug called tacrolimus, which is an immune-lowering drug (an immunosuppressant) given after transplant to help prevent certain complications, can be given safely for a shorter period of time than it has been in the past. The experiences with immunosuppression duration with other allogeneic HSCT platforms cannot be directly extrapolated to the high-dose posttransplantation cyclophosphamide platform (another type of immunosuppressant given after transplant to help prevent GVHD). There are presently no published data on the minimum required duration of tacrolimus after nonmyeloablative HSCT that includes high-dose Cy as part of postgrafting immunosuppression. The effectiveness of high-dose posttransplantation Cy in GVHD prevention, however, permits the investigation of this question. At the present time there are few or no cures for diseases studied on this trial outside of a bone marrow or peripheral blood transplant. The peripheral blood for this transplant comes from a relative who is a half-match or "haplo" match to the participant. Possible donors include parents, siblings, and children. In order to help the bone marrow grow, or "take", inside the body, participants will receive chemotherapy and radiation before the transplant. After the transplant participants will receive high doses of cyclophosphamide (Cytoxan®) along with other medications to lower the immune system, such as tacrolimus. These medications may lower the risk of graft versus host disease (GVHD) and of rejection of the peripheral blood graft.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBSCT D90 | Experimental | Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 90 or Day 180 depending on GVHD status. |
|
| PBSCT D60 | Experimental | Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 60 or Day 180 depending on GVHD status. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine | Drug | Days -6 through -2: 30 mg/m^2 IV daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D90 Cohort) | This outcome measures the feasibility of stopping prophylactic tacrolimus at Day 90. | Day 90 |
| Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D60 Cohort) | This outcome measures the feasibility of stopping prophylactic tacrolimus at Day 60. | Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grades III-IV Acute GVHD, Days 90-180 (D90) | Number of participants who experience grade III or IV acute GVHD between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable. | Between Day 90 and Day 180 |
| Number of Participants With Grades III-IV Acute GVHD, Days 60-180 (D60) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy E DeZern, MD | 410-502-7208 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PBSCT D90 | Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 90 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2017 |
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| Cyclophosphamide | Drug | Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily |
|
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| Total body irradiation | Radiation | Day -1: 200 cGy in a single fraction |
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| Tacrolimus | Drug | Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. |
|
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| Mycophenolate mofetil | Drug | Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day) |
|
|
Number of participants who experience grade III or IV acute GVHD between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable. |
| Between Day 60 and Day 180 |
| Number of Participants With Chronic GVHD, Days 90-180 (D90) | Number of participants who experience chronic GVHD requiring additional immunosuppressive therapy between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable. | Between Day 90 and Day 180 |
| Number of Participants With Chronic GVHD, Days 60-180 (D60) | Number of participants who experience chronic GVHD requiring additional immunosuppressive therapy between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable. | Between Day 60 and Day 180 |
| Number of Participants Who Experience Graft Failure, Days 90-180 (D90) | Number of participants who experience graft failure between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable. | Between Day 90 and Day 180 |
| Number of Participants Who Experience Graft Failure, Days 60-180 (D60) | Number of participants who experience graft failure between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable. | Between Day 60 and Day 180 |
| Number of Participants Who Experience Disease Relapse, Days 90-180 (D90) | Number of participants who experience disease relapse between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable. | Between Day 90 and Day 180 |
| Number of Participants Who Experience Disease Relapse, Days 60-180 (D60) | Number of participants who experience disease relapse between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable. | Between Day 60 and Day 180 |
| Number of Participants Who Experience Non-relapse Mortality, Days 90-180 (D90) | Number of participants who die for any reason other than disease relapse between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable. | Between Day 90 and Day 180 |
| Number of Participants Who Experience Non-relapse Mortality, Days 60-180 (D60) | Number of participants who die for any reason other than disease relapse between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable. | Between Day 60 and Day 180 |
| Number of Participants Who Experience Grades III-IV GVHD, Day 360 (D90) | Number of participants who experience grade III or IV GVHD by Day 360. All participants are evaluable. | Day 360 |
| Number of Number of Participants Who Experience Grades III-IV GVHD, Day 360 (D60) | Number of participants who experience grade III or IV GVHD by Day 360. All participants are evaluable. | Day 360 |
| Number of Number of Participants With Severe Chronic GVHD, Day 360 (D90) | Number of participants who experience severe chronic GVHD requiring additional immunosuppressive therapy by Day 360. All participants are evaluable. | Day 360 |
| Number of Number of Participants With Severe Chronic GVHD, Day 360 (D60) | Number of participants who experience severe chronic GVHD requiring additional immunosuppressive therapy by Day 360. All participants are evaluable. | Day 360 |
| Number of Number of Participants Who Experience Graft Failure, Day 360 (D90) | Number of participants who experience graft failure by Day 360. All participants are evaluable. | Day 360 |
| Number of Number of Participants Who Experience Graft Failure, Day 360 (D60) | Number of participants who experience graft failure by Day 360. All participants are evaluable. | Day 360 |
| Number of Participants Who Experience Relapse, Day 360 (D90) | Number of participants who experience disease relapse by Day 360. All participants are evaluable. | Day 360 |
| Number of Participants Who Experience Relapse, Day 360 (D60) | Number of participants who experience disease relapse by Day 360. All participants are evaluable. | Day 360 |
| Number of Participants Who Experience Non-relapse Mortality, Day 360 (D90) | Number of participants who die for any reason other than disease relapse by Day 360. All participants are evaluable. | Day 360 |
| Number of Participants Who Experience Non-relapse Mortality, Day 360 (D60) | Number of participants who die for any reason other than disease relapse by Day 360. All participants are evaluable. | Day 360 |
| FG001 | PBSCT D60 | Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 60 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day) |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PBSCT D90 | Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 90 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day) |
| BG001 | PBSCT D60 | Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 60 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D90 Cohort) | This outcome measures the feasibility of stopping prophylactic tacrolimus at Day 90. | Safety stopping criteria were not met after discontinuation of tacrolimus at day 90. | Posted | Count of Participants | Participants | Day 90 |
|
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D60 Cohort) | This outcome measures the feasibility of stopping prophylactic tacrolimus at Day 60. | Of the 42 patients in the D60 cohort who stopped IS early as prespecified, 10 subsequently relapsed. | Posted | Count of Participants | Participants | Day 60 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Grades III-IV Acute GVHD, Days 90-180 (D90) | Number of participants who experience grade III or IV acute GVHD between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable. | Of the 57 patients in the D90 cohort, 33 stopped tactolimus early as planned. | Posted | Count of Participants | Participants | Between Day 90 and Day 180 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Grades III-IV Acute GVHD, Days 60-180 (D60) | Number of participants who experience grade III or IV acute GVHD between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable. | Posted | Count of Participants | Participants | Between Day 60 and Day 180 |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Chronic GVHD, Days 90-180 (D90) | Number of participants who experience chronic GVHD requiring additional immunosuppressive therapy between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable. | Of the 57 patients in the D90 cohort, 33 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Between Day 90 and Day 180 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Chronic GVHD, Days 60-180 (D60) | Number of participants who experience chronic GVHD requiring additional immunosuppressive therapy between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable. | Of the 60 patients in the D60 cohort, 42 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Between Day 60 and Day 180 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experience Graft Failure, Days 90-180 (D90) | Number of participants who experience graft failure between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable. | Of the 57 patients in the D90 cohort, 33 stopped IS early as planned. | Posted | Count of Participants | Participants | Between Day 90 and Day 180 |
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| Secondary | Number of Participants Who Experience Graft Failure, Days 60-180 (D60) | Number of participants who experience graft failure between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable. | Of the 60 patients in the D60 cohort, 42 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Between Day 60 and Day 180 |
|
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| Secondary | Number of Participants Who Experience Disease Relapse, Days 90-180 (D90) | Number of participants who experience disease relapse between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable. | Of the 57 patients in the D90 cohort, 33 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Between Day 90 and Day 180 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experience Disease Relapse, Days 60-180 (D60) | Number of participants who experience disease relapse between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable. | Of the 60 patients in the D60 cohort, 42 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Between Day 60 and Day 180 |
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| Secondary | Number of Participants Who Experience Non-relapse Mortality, Days 90-180 (D90) | Number of participants who die for any reason other than disease relapse between Day 90 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 90 are evaluable. | Of the 57 patients in the D90 cohort, 33 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Between Day 90 and Day 180 |
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| Secondary | Number of Participants Who Experience Non-relapse Mortality, Days 60-180 (D60) | Number of participants who die for any reason other than disease relapse between Day 60 and Day 180. Only participants who are able to stop prophylactic tacrolimus at Day 60 are evaluable. | Of the 60 patients in the D60 cohort, 42 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Between Day 60 and Day 180 |
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| Secondary | Number of Participants Who Experience Grades III-IV GVHD, Day 360 (D90) | Number of participants who experience grade III or IV GVHD by Day 360. All participants are evaluable. | Of the 57 patients in the D90 cohort, 33 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Day 360 |
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| Secondary | Number of Number of Participants Who Experience Grades III-IV GVHD, Day 360 (D60) | Number of participants who experience grade III or IV GVHD by Day 360. All participants are evaluable. | Of the 60 patients in the D60 cohort, 42 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Day 360 |
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| Secondary | Number of Number of Participants With Severe Chronic GVHD, Day 360 (D90) | Number of participants who experience severe chronic GVHD requiring additional immunosuppressive therapy by Day 360. All participants are evaluable. | Of the 57 patients in the D90 cohort, 33 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Day 360 |
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| Secondary | Number of Number of Participants With Severe Chronic GVHD, Day 360 (D60) | Number of participants who experience severe chronic GVHD requiring additional immunosuppressive therapy by Day 360. All participants are evaluable. | Of the 60 patients in the D60 cohort, 42 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Day 360 |
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| Secondary | Number of Number of Participants Who Experience Graft Failure, Day 360 (D90) | Number of participants who experience graft failure by Day 360. All participants are evaluable. | Of the 57 patients in the D90 cohort, 33 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Day 360 |
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| Secondary | Number of Number of Participants Who Experience Graft Failure, Day 360 (D60) | Number of participants who experience graft failure by Day 360. All participants are evaluable. | Of the 60 patients in the D60 cohort, 42 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Day 360 |
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| Secondary | Number of Participants Who Experience Relapse, Day 360 (D90) | Number of participants who experience disease relapse by Day 360. All participants are evaluable. | Of the 57 patients in the D90 cohort, 33 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Day 360 |
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| Secondary | Number of Participants Who Experience Relapse, Day 360 (D60) | Number of participants who experience disease relapse by Day 360. All participants are evaluable. | Of the 60 patients in the D60 cohort, 42 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Day 360 |
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| Secondary | Number of Participants Who Experience Non-relapse Mortality, Day 360 (D90) | Number of participants who die for any reason other than disease relapse by Day 360. All participants are evaluable. | Of the 57 patients in the D90 cohort, 33 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Day 360 |
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| Secondary | Number of Participants Who Experience Non-relapse Mortality, Day 360 (D60) | Number of participants who die for any reason other than disease relapse by Day 360. All participants are evaluable. | Of the 60 patients in the D60 cohort, 42 stopped tacrolimus early as planned. | Posted | Count of Participants | Participants | Day 360 |
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adverse event data were collected for each particpant for at minimum 1 year. Median follow-up of 41 months in the D90 cohort and 27 months in the D60 cohort.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PBSCT D90 | Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 90 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day) | 12 | 57 | 9 | 57 | 35 | 57 |
| EG001 | PBSCT D60 | Non-myeloablative peripheral blood stem cell transplant (PBSCT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Tacrolimus will be stopped at either Day 60 or Day 180 depending on GVHD status. Fludarabine: Days -6 through -2: 30 mg/m^2 IV daily Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily Total body irradiation: Day -1: 200 cGy in a single fraction Tacrolimus: Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status. Mycophenolate mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day) | 10 | 60 | 5 | 60 | 16 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe cGVHD | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neutropenic fever | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Dezern | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 410-502-7208 | adezern1@jhmi.edu |
| Apr 2, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D015463 | Leukemia, Prolymphocytic |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D009196 | Myeloproliferative Disorders |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D010265 | Paraproteinemias |
| D055728 | Primary Myelofibrosis |
| D011087 | Polycythemia Vera |
| D013920 | Thrombocythemia, Essential |
| D007952 | Leukemia, Plasma Cell |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D001778 | Blood Coagulation Disorders |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D003520 | Cyclophosphamide |
| D014916 | Whole-Body Irradiation |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D018942 | Macrolides |
| D007783 | Lactones |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
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| Between 18 and 65 years |
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| >=65 years |
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