Overview

Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-Engraft Malignancies

Status:
Completed
Trial end date:
2021-04-01
Target enrollment:
0
Participant gender:
All
Summary
To see if it is possible to use short-duration tacrolimus after a peripheral blood stem cell transplant in certain malignancies that are considered difficult to engraft.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Criteria
Inclusion Criteria:

- Presence of a suitable related HLA-haploidentical or -matched stem cell donor, or a
10/10 matched unrelated donor

- Eligible diagnoses: myelodysplastic syndrome (MDS) with at least 1 poor-risk feature;
small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL) with 17p
deletion or with progression < 6 months after a second or greater treatment regimen;
T-cell prolymphocytic leukemia (PLL) in partial response or better; interferon- or
tyrosine-kinase-refractory chronic myeloid leukemia (CML), or CML in second or
subsequent chronic phase; Philadelphia chromosome negative (Ph-) myeloproliferative
disease, including myelofibrosis; Multiple myeloma or plasma cell leukemia in partial
response or better; Hematologic malignancy in complete remission with minimal residual
disease (MRD) detectable by conventional cytogenetics, FISH, flow cytometry, or
molecular testing

- Any previous autologous transplant must have occurred > 3 months ago

- Left ventricular ejection fraction (LVEF) >= 35%, or shortening fraction > 25%

- Bilirubin <= 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis)

- AST and ALT <= 5 x institutional upper limit of normal

- FEV1 and FVC >= 40% of predicted; if unable to perform pulmonary function testing,
oxygen saturation > 92% on room air

- ECOG performance status <= 2, or Karnofsky/Lansky status >= 60

Exclusion Criteria:

- Pregnancy or active breastfeeding

- Uncontrolled active infection

- Previous allogeneic transplant

- Active extramedullary leukemia or active central nervous system (CNS) malignant
disease