Study Stopped
Toxicity
A Study of Haploidentical Bone Marrow Transplant for Patients With Hematologic Malignancies
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
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2012
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 21, 2012
CompletedFirst Submitted
Initial submission to the registry
August 29, 2013
CompletedFirst Posted
Study publicly available on registry
December 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedResults Posted
Study results publicly available
November 10, 2025
CompletedNovember 10, 2025
October 1, 2025
3.6 years
August 29, 2013
October 13, 2023
October 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
180 days after transplantation
Day 180
Study Arms (1)
cyclophosphamide post BMT
EXPERIMENTALCyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Interventions
Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Eligibility Criteria
You may qualify if:
- 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.
- 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).
- Burkitt's lymphoma: second or subsequent Complete Response (CR).
- Lymphoma
- Patients with adequate physical function
- Performance status: Karnofsky score 70-100%.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSD Medical Center
La Jolla, California, 92093, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michelle Padilla
- Organization
- University of California, San Diego
Study Officials
- PRINCIPAL INVESTIGATOR
Caitlin Caitlin, MD
University of California, San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Clinical Professor
Study Record Dates
First Submitted
August 29, 2013
First Posted
December 7, 2015
Study Start
September 21, 2012
Primary Completion
May 12, 2016
Study Completion
January 1, 2023
Last Updated
November 10, 2025
Results First Posted
November 10, 2025
Record last verified: 2025-10