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The purpose of this study is to determine the safety and efficacy of post-transplant cyclophosphamide and a post-transplant infusion of donor cells, that have been specially processed to remove alpha beta t-cells, in patients undergoing a haploidentical allogeneic stem cell transplant to help reduce the risk of relapse without increasing the risk of graft-versus-host disease.
Transplant patients participating in this clinical trial will receive one of 3 standard pre-transplant chemotherapy preparative regimens as appropriate for their specific disease. They will then receive a standard non-manipulated donor stem cell infusion on transplant day (day 0) followed by cyclophosphamide (days +3 and +4) and an alpha-beta t-cell reduced donor stem cell infusion on day +7.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alpha-beta depleted T-cell infusion | Other | Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide. | Device | Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD) | Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria. | From baseline and before day +100 of transplant. |
| Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD) | Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria. | From baseline and before day +100 of transplant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayman Saad, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Medical Center (University of Alabama at Birmingham) | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17785583 | Background | Lee SJ, Klein J, Haagenson M, Baxter-Lowe LA, Confer DL, Eapen M, Fernandez-Vina M, Flomenberg N, Horowitz M, Hurley CK, Noreen H, Oudshoorn M, Petersdorf E, Setterholm M, Spellman S, Weisdorf D, Williams TM, Anasetti C. High-resolution donor-recipient HLA matching contributes to the success of unrelated donor marrow transplantation. Blood. 2007 Dec 15;110(13):4576-83. doi: 10.1182/blood-2007-06-097386. Epub 2007 Sep 4. | |
| 22046559 |
| Label | URL |
|---|---|
| Click here for more information about the Bone Marrow Transplantation and Cell Therapy Program at the University of Alabama at Birmingham. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alpha-beta Depleted T-cell Infusion | Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide. Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide. |
| 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 | Mar 1, 2018 |
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| Background |
| Alshemmari S, Ameen R, Gaziev J. Haploidentical hematopoietic stem-cell transplantation in adults. Bone Marrow Res. 2011;2011:303487. doi: 10.1155/2011/303487. Epub 2011 Jul 13. |
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| Background | Kaplan, EL, Meier, P. Nonparametric estimation from incomplete observations. Journal of the American Statistical Association 53(282): 457-481, 1958. |
| Background | Gray, RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. The Annals of Statistics, 1141-1154, 1988. |
| COMPLETED |
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| NOT COMPLETED |
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we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough T cells.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alpha-beta Depleted T-cell Infusion | Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide. Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough T cells. | Count of Participants | Participants | No |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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 | Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD) | Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria. | we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough CD34 HSCT.. | Posted | Count of Participants | Participants | No | From baseline and before day +100 of transplant. |
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| Primary | Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD) | Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria. | we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough CD34 HSCT. | Posted | Count of Participants | Participants | No | From baseline and before day +100 of transplant. |
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Baseline through one year.
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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 | Alpha-beta Depleted T-cell Infusion | Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide. Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.: Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide. | 3 | 4 | 2 | 4 | 2 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Graft Failure (not related to study) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tiffany D Hill | University of Alabama at Birmingham | 205-996-8023 | tiffanydhill@uabmc.edu |
| Dec 17, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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