Haploidentical Stem Cell Transplantation Using Post-Transplant Cyclophosphamide
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 16 - 90 |
| Updated: | 3/2/2019 |
| Start Date: | January 18, 2017 |
| End Date: | January 31, 2021 |
| Contact: | Zeina Al-Mansour, MD |
| Email: | Zeina.Al-Mansour@lumc.edu |
| Phone: | 708-327-2336 |
Safety, Efficacy and Feasibility of Haploidentical Stem Cell Transplantation (Haplo-SCT) Using Post-Transplant Cyclophosphamide (PTCy) as an Alternative Donor Source for Patients Who Lack a Matched Sibling/Unrelated Donor Options
Historically, the best results of allogeneic SCT have been obtained when the stem cell donor
is a human leukocyte antigen (HLA)-matched sibling, however, this is only available for
approximately 30 percent of patients in need for SCT. Alternative donor sources include
matched unrelated donor utilizing the donor registry, cord blood transplant and mismatched
donor transplant. A human leukocyte antigen (HLA)-haploidentical donor is one who shares, by
common inheritance, exactly one HLA haplotype with the recipient, and includes the biologic
parents, biologic children and full or half siblings. There is strong body of evidence
supporting the use of haplo-SCT in patient who lack a matched sibling or unrelated donor with
high rates of successful engraftment, effective Graft Versus Host Disease (GVHD) control and
favorable outcomes comparative to those seen using other allograft sources, including
HLA-matched sibling SCT. Furthermore, it provides a cost-efficient donor option in a timely
manner especially for patients who need to proceed quickly to transplant due to concern of
disease relapse/progression.
is a human leukocyte antigen (HLA)-matched sibling, however, this is only available for
approximately 30 percent of patients in need for SCT. Alternative donor sources include
matched unrelated donor utilizing the donor registry, cord blood transplant and mismatched
donor transplant. A human leukocyte antigen (HLA)-haploidentical donor is one who shares, by
common inheritance, exactly one HLA haplotype with the recipient, and includes the biologic
parents, biologic children and full or half siblings. There is strong body of evidence
supporting the use of haplo-SCT in patient who lack a matched sibling or unrelated donor with
high rates of successful engraftment, effective Graft Versus Host Disease (GVHD) control and
favorable outcomes comparative to those seen using other allograft sources, including
HLA-matched sibling SCT. Furthermore, it provides a cost-efficient donor option in a timely
manner especially for patients who need to proceed quickly to transplant due to concern of
disease relapse/progression.
An open label, single-arm, single-center study to evaluate the safety, efficacy and
feasibility of haplo-SCT as an alternative donor source for patients who lack a matched
sibling/unrelated donor options. The choice of the chemotherapy treatment for transplantation
will be up to the investigator. Post-transplant cyclophosphamide will serve as the backbone
of the immunosuppression treatment to prevent GVHD.
GVHD Prevention Treatment:
Cyclophosphamide will be administered IV on Day 3 and Day 5 post transplant.
Tacrolimus will be administered IV until patient can take it by mouth starting on day of
transplant and continue approximately 100 days post-transplant.
Mycophenolate mofetil will be administered IV until patient can take it by mouth starting on
Day 1 post transplant until 28 days.
feasibility of haplo-SCT as an alternative donor source for patients who lack a matched
sibling/unrelated donor options. The choice of the chemotherapy treatment for transplantation
will be up to the investigator. Post-transplant cyclophosphamide will serve as the backbone
of the immunosuppression treatment to prevent GVHD.
GVHD Prevention Treatment:
Cyclophosphamide will be administered IV on Day 3 and Day 5 post transplant.
Tacrolimus will be administered IV until patient can take it by mouth starting on day of
transplant and continue approximately 100 days post-transplant.
Mycophenolate mofetil will be administered IV until patient can take it by mouth starting on
Day 1 post transplant until 28 days.
Inclusion Criteria:
- Ages 16 years old and up
- Performance Status 70 percent or above
- Patients should have the following diseases:
- Acute myelogenous leukemia (AML)
- Acute lymphocytic leukemia or lymphoblastic lymphoma (ALL)
- Transfusion dependent myelodysplastic syndrome (MDS)
- Non-Hodgkin's Lymphoma (NHL)
- Chronic lymphocytic leukemia (CLL)
- Pulmonary function as measured by forced expiratory volume at one second (FEV1) and/or
corrected diffusing capacity of lung for carbon monoxide (DLCO) at 60 percent of
predicted or above
- Left ventricular ejection fraction at 45 percent or above
- If the donor-specific HLA antibodies (DSA) are positive, the patient must undergo a
desensitization protocol resulting in undetectable DSA prior to day of transplant
Exclusion Criteria:
- Less than twenty-one days have elapsed since the subject's last radiation or
chemotherapy prior to conditioning (except for hydroxyurea)
- Uncontrolled bacterial, fungal or viral infections at time of study enrollment
- Positive for HIV, human T-cell leukemia virus (HTLV-1) and/or Hepatitis C
- Subjects with signs/symptoms of active central nervous system (CNS) disease
We found this trial at
1
site
2160 South 1st Avenue
Maywood, Illinois 60153
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Patrick Stiff, MD
Phone: 708-327-2336
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