Summary

for people ages 18-70 (full criteria)
at La Jolla, California
study started
estimated completion:
Grace Ku

Description

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.

Official Title

A Phase 2 Study of Nonmyeloablative Conditioning With Transplantation of Partially Human Leukocyte Antigen (HLA)-Mismatched Bone Marrow and Post-transplant Cyclophosphamide for Patients With Hematologic Malignancies

Details

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).

Keywords

Hematologic Malignancies Neoplasms Cyclophosphamide Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant cyclophosphamide post BMT

Eligibility

You can join if…

Open to people ages 18-70

  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.
  6. Acute Lymphoblastic Leukemia in high risk 1st complete response (CR1)
  7. Acute Myelogenous Leukemia in high risk 1st complete response (CR1)
  8. Acute Leukemias in 2nd or subsequent Complete Response (CR)
  9. Biphenotypic/Undifferentiated Leukemias in 1st or subsequent Complete Response(CR).
  10. Burkitt's lymphoma: second or subsequent Complete Response (CR).
  11. Lymphoma
  12. Patients with adequate physical function
  13. Performance status: Karnofsky score 70-100%.

You CAN'T join if...

Location

  • UCSD Medical Center
    La Jolla California 92093 United States

Lead Scientist

  • Grace Ku
    Authored (or co-authored) 40 research publications

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT02623439
Phase
Phase 2
Study Type
Interventional
Last Updated