Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-… (NCT02556931) | Clinical Trial Compass
CompletedPhase 2
Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-Engraft Malignancies
United States117 participantsStarted 2015-12
Plain-language 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.
Who can participate
SexALL
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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 tra…
What they're measuring
1
Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D90 Cohort)
Timeframe: Day 90
2
Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D60 Cohort)
Timeframe: Day 60
Trial details
NCT IDNCT02556931
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins