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Toxicity
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The primary objective is to determine overall survival 180 days after transplantation involving HLA-haploidentical stem cell/bone marrow graft, and post-transplant Cy.
Study Design: This is a single center Phase 2 study of myeloablative (MA) and nonmyeloablative (NMA) conditioning, transplantation of partially HLA-mismatched bone marrow or peripheral blood stem cells and post-transplantation cyclophosphamide (Cy) in patients with hematologic malignancies including:
Primary Objective:
The primary objective is to determine overall survival 180 days after transplantation involving Myeloablative and Non myeloablative conditioning, HLA-haploidentical marrow or peripheral blood stem cell grafts, and post-transplant Cyclophosphamide as GVHD prophylaxis.
Secondary Objectives:
Secondary objectives include estimating overall and progression-free survival at 100 days, 180 days, and one year after transplantation, treatment-related mortality, incidence of neutrophil and platelet recovery or engraftment, incidence of graft failure, cumulative incidence of acute and chronic Graft versus Host Disease (GVHD), incidence of infections, and cumulative incidence of relapse/progression. The investigators will also examine the amount of time to transplant (day of unrelated search initiation to day 0).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cyclophosphamide post BMT | Experimental | Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant | Drug | Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 180 days after transplantation | Day 180 |
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Inclusion Criteria:
Age: Subjects 18-70 years old.
Donor must be 18 years of age.
HLA typing will be performed at high resolution. A minimum match of 5 out of 10 is required.
Patients must have received multi-agent chemotherapy within 3 months of consent date (measured from the start date of chemotherapy).
Acute Leukemias.
Burkitt's lymphoma: second or subsequent Complete Response (CR).
Lymphoma
Patients with adequate physical function
Performance status: Karnofsky score 70-100%.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caitlin Caitlin, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center | La Jolla | California | 92093 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | cyclophosphamide post BMT | Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cyclophosphamide Post BMT | Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Overall Survival | 180 days after transplantation | Posted | Count of Participants | Participants | Day 180 |
|
|
1 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 | cyclophosphamide post BMT | Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Human herpesvirus 6 (HHV-6) | Immune system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Padilla | University of California, San Diego | (858) 822-5354 | CancerCTO@health.ucsd.edu |
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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 | Jun 12, 2014 | Oct 21, 2025 | Prot_SAP_000.pdf |
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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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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 5 |
| 8 |
| 5 |
| 8 |
| 8 |
| 8 |
| CMV | Immune system disorders | Systematic Assessment |
|
| Adenovirus | Immune system disorders | Systematic Assessment |
|
| Acute GVHD | Immune system disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Enterococcus Faecalis UTI | Infections and infestations | Systematic Assessment |
|
| BC (+) Rothia mucilaginosa septicemia | Infections and infestations | Systematic Assessment |
|
| CMV | Immune system disorders | Systematic Assessment |
|
| acute GVHD | Immune system disorders | Systematic Assessment |
|
| aspergillosis | Immune system disorders | Systematic Assessment |
|
| stenotrophomomas pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cytokine storm | Blood and lymphatic system disorders | Systematic Assessment |
|
| vancomycin-resistant enterococcus (VRE) | Infections and infestations | Systematic Assessment |
|
| pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| extended spectrum beta-lactamase (ESBL) E.Coli | Infections and infestations | Systematic Assessment |
|
| Systemic inflammatory response syndrome (SIRS) | Infections and infestations | Systematic Assessment |
|
| Clostridioides difficile or C-diff | Infections and infestations | Systematic Assessment |
|
| CMV viremia | Immune system disorders | Systematic Assessment |
|
| respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |