Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haploidentical Related Hematopoietic
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any - 75 |
Updated: | 1/18/2019 |
Start Date: | January 24, 2017 |
End Date: | January 2021 |
Contact: | Timothy Krepski |
Email: | tkrepsk1@fairview.org |
Phone: | 612-273-2800 |
Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies
This is a single institution phase II study of a reduced intensity conditioning (RIC)
followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with
diagnosis of hematologic malignancy. Conditioning will consists of fludarabine,
cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a
melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index (CI)
>3. This study uses a two-stage phase II design with accrual goal of 44 patients, using 22
patients separately for arms A and B.
followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with
diagnosis of hematologic malignancy. Conditioning will consists of fludarabine,
cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a
melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index (CI)
>3. This study uses a two-stage phase II design with accrual goal of 44 patients, using 22
patients separately for arms A and B.
Inclusion Criteria:
- Karnofsky performance status of ≥70% or Lansky play score ≥ 70%
- A related haploidentical bone marrow donor with up to 2 or 3 HLA locus-mismatches
- The donor and recipient must be HLA identical for at least one haplotype (using high
resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and
HLA-DRB1.
- Adequate liver and renal function
- Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left
ventricular ejection fraction ≥ 40%
- Diffusion capacity corrected (DLCOcorr) > 40% predicted, and absence of O2
requirements
- > 6 months after prior autologous transplant (if applicable)
- Agrees to use contraception during study treatment
- Voluntary written consent (adult or parent/guardian with presentation of the minor
information sheet, if appropriate)
Exclusion Criteria:
- < 70 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor
- Pregnancy or breastfeeding
- Evidence of HIV infection or known HIV positive serology
- Current active and uncontrolled serious infection
- Acute leukemia in morphologic relapse/persistent disease defined as > 5% blasts in
normocellular bone marrow OR any % blasts if blasts have unique morphologic markers
(e.g. Auer rods).
- CML in blast crisis
- Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressive on
salvage therapy.
- stable non-bulky disease is acceptable.
- Active central nervous system malignancy
Criteria For Donor Selection:
- Donors must be HLA-haploidentical relatives of the patient, defined as having a shared
HLA haplotype between donor and patient at HLA-A, -B, -C, and -DRB1.
- Eligible donors (14-70 years old) include biological children, siblings or half
siblings, or parents, able and willing to undergo bone marrow harvesting.
- For donors <18 years, the maximum recipient weight (actual body weight) should not
exceed 1.25 times the donor weight (actual body weight)1 In addition, bone marrow
product volume should be limited to 20 ml/kg donor weight for donors <18 years.
We found this trial at
1
site
425 E River Pkwy # 754
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
612-624-2620
Phone: 612-273-2800
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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