Stem Cell Transplantation From HLA Partially-Matched Related Donors for Patients With Hematologic Malignancies
A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation From HLA Partially-Matched Related Donors for Patients With Hematologic Malignancies
1 other identifier
interventional
10
1 country
1
Brief Summary
This clinical pilot trial is intended to evaluate the feasibility, efficacy and safety of hematopoietic stem cell transplantation (HSCT) from Human Leukocyte Antigen (HLA)-mismatched related donors for children and young adults with hematologic malignancies who lack a suitably matched related or unrelated donor. The methodology will be one that has been successfully utilized in adult patients at Thomas Jefferson University.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2014
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 30, 2015
CompletedFirst Posted
Study publicly available on registry
October 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2022
CompletedApril 7, 2022
April 1, 2022
7.1 years
September 30, 2015
April 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hematopoietic engraftment
Absolute neutrophil count \>500/microliter x 3 consecutive days
Day +30 post-transplantation
Secondary Outcomes (4)
2-Year disease-free survival
2 years post-transplantation
Grade II-IV GvHD
Day +100 post-transplantatation
Grade III-IV GvHD
Day +100 post-transplantation
Relapse rate
2 years post-transplantation
Study Arms (1)
Haploidentical Stem Cell Transplantation
EXPERIMENTALSubjects will receive pretransplantation conditioning of total-body irradiation (1,200 cGy delivered in 8 fractions over 4 days \[Days -9 through -6\] and cyclophosphamide (60 mg/kg IV daily x 2 on Days -3 and -2). Donor lymphocyte infusion will occur on day -6; donor CD34+ cells will be infused on Day 0.
Interventions
1,200 cGy, delivered in 8 fractions of 150 cGy bid x 4 days
Cyclophosphamide 60 mg/kg IV daily x 2 consecutive days
DLI containing 1 x 10E8/kg donor T-cells
2-10 x 10E6/kg donor CD34+ selected cells
Eligibility Criteria
You may qualify if:
- Acute lymphoblastic leukemia
- Acue myelogenous leukemia
- Myelodysplastic syndrome
- Non-Hodgkin lymphoma
- Chronic myelogenous leukemia
- Adequate lung, liver, renal, cardiac function
- Performance status \>70
- Available related donor who is mismatched at ≥ 2 HLA alleles
You may not qualify if:
- Available HLA-identical related donor
- HIV positive
- Active uncontrolled infection
- Pregnancy
- Performance status ≤70
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
- New York Blood Centercollaborator
Study Sites (1)
Cohen Children's Medical Center
New Hyde Park, New York, 11040, United States
Related Publications (1)
Grosso D, Gaballa S, Alpdogan O, Carabasi M, Filicko-O'Hara J, Kasner M, Martinez-Outschoorn U, Wagner JL, O'Hara W, Rudolph S, Chervoneva I, Colombe B, Farley PC, Flomenberg P, Pro B, Sharma M, Shi W, Weiss M, Flomenberg N. A two-step approach to myeloablative haploidentical transplantation: low nonrelapse mortality and high survival confirmed in patients with earlier stage disease. Biol Blood Marrow Transplant. 2015 Apr;21(4):646-52. doi: 10.1016/j.bbmt.2014.12.019. Epub 2014 Dec 23.
PMID: 25542159BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joel A Brochstein, MD
Cohen Children's Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Chief for Cellular Therapy, CCMC
Study Record Dates
First Submitted
September 30, 2015
First Posted
October 2, 2015
Study Start
December 1, 2014
Primary Completion
January 14, 2022
Study Completion
February 14, 2022
Last Updated
April 7, 2022
Record last verified: 2022-04