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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT02623439
Other study ID # 120931
Secondary ID
Status Suspended
Phase Phase 2
First received
Last updated
Start date July 2012
Est. completion date July 2022

Study information

Verified date July 2022
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Suspended
Enrollment 20
Est. completion date July 2022
Est. primary completion date July 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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%. Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant

Locations

Country Name City State
United States UCSD Medical Center La Jolla California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary endpoint is overall survival at 180 days from the time of transplantation. 180 days after transplantation Day 180
Secondary Incidence of Neutrophil Engraftment incidence of neutrophil engraftment at Day 180 180 days post transplant day 0
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