Hematologic Malignancies
Conditions
Keywords
hematologic malignancies
Brief summary
The primary objective is to determine overall survival 180 days after transplantation involving HLA-haploidentical stem cell/bone marrow graft, and post-transplant Cy.
Detailed description
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: 1. Acute lymphoblastic leukemia/lymphoma, acute myelogenous leukemia, and Burkitt's lymphoma in remission. 2. Relapsed lymphoma, including marginal zone B cell lymphoma, follicular lymphoma, and chemotherapy-sensitive large-cell or Hodgkin lymphoma. 3. Myelodysplastic Syndrome (MDS) 4. Blastic plasmacytoid dendritic cell neoplasm 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).
Interventions
DRUGCyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Sponsors
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age: Subjects 18-70 years old. 2. Donor must be 18 years of age. 3. HLA typing will be performed at high resolution. A minimum match of 5 out of 10 is required. 4. Patients must have received multi-agent chemotherapy within 3 months of consent date (measured from the start date of chemotherapy). 5. Acute Leukemias. * Acute Lymphoblastic Leukemia in high risk 1st complete response (CR1) * Acute Myelogenous Leukemia in high risk 1st complete response (CR1) * Acute Leukemias in 2nd or subsequent Complete Response (CR) * Biphenotypic/Undifferentiated Leukemias in 1st or subsequent Complete Response (CR). 6. Burkitt's lymphoma: second or subsequent Complete Response (CR). 7. Lymphoma 8. Patients with adequate physical function 9. Performance status: Karnofsky score 70-100%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Day 180 | 180 days after transplantation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen Failure | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Cyclophosphamide Post BMT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 8 |
| other Total, other adverse events | 8 / 8 |
| serious Total, serious adverse events | 5 / 8 |
Outcome results
Primary
Overall Survival
180 days after transplantation
Time frame: Day 180
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| cyclophosphamide post BMT | Overall Survival | 3 Participants |