Phase 2
Completed N=117
Shorter Course Tacro After NMA, Related Donor PBSCT With High-dose Posttransplant Cy for Hard-to-Engraft Malignancies
Myelodysplastic Syndromes · Chronic myelomonocytic leukemia · small lymphocytic lymphoma · Chronic Lymphocytic Leukemia
Source: ClinicalTrials.gov NCT02556931 ↗
Enrolled (actual)
117
Serious AEs
12.0%
Results posted
Nov 2022
Primary outcomePrimary: Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D90 Cohort) — 33 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D90 Cohort) |
33 | — |
| PRIMARY Percentage of Participants Who Are Able to Stop Prophylactic Tacrolimus (D60 Cohort) |
42 | — |
| SECONDARY Number of Participants With Grades III-IV Acute GVHD, Days 90-180 (D90) |
1 | — |
| SECONDARY Number of Participants With Grades III-IV Acute GVHD, Days 60-180 (D60) |
3 | — |
| SECONDARY Number of Participants With Chronic GVHD, Days 90-180 (D90) |
2 | — |
| SECONDARY Number of Participants With Chronic GVHD, Days 60-180 (D60) |
1 | — |
| SECONDARY Number of Participants Who Experience Graft Failure, Days 90-180 (D90) |
— | — |
| SECONDARY Number of Participants Who Experience Graft Failure, Days 60-180 (D60) |
1 | — |
| SECONDARY Number of Participants Who Experience Disease Relapse, Days 90-180 (D90) |
14 | — |
| SECONDARY Number of Participants Who Experience Disease Relapse, Days 60-180 (D60) |
10 | — |
| SECONDARY Number of Participants Who Experience Non-relapse Mortality, Days 90-180 (D90) |
1 | — |
| SECONDARY Number of Participants Who Experience Non-relapse Mortality, Days 60-180 (D60) |
2 | — |
| SECONDARY Number of Participants Who Experience Grades III-IV GVHD, Day 360 (D90) |
16 | — |
| SECONDARY Number of Number of Participants Who Experience Grades III-IV GVHD, Day 360 (D60) |
18 | — |
| SECONDARY Number of Number of Participants With Severe Chronic GVHD, Day 360 (D90) |
7 | — |
| SECONDARY Number of Number of Participants With Severe Chronic GVHD, Day 360 (D60) |
5 | — |
| SECONDARY Number of Number of Participants Who Experience Graft Failure, Day 360 (D90) |
— | — |
| SECONDARY Number of Number of Participants Who Experience Graft Failure, Day 360 (D60) |
2 | — |
| SECONDARY Number of Participants Who Experience Relapse, Day 360 (D90) |
14 | — |
| SECONDARY Number of Participants Who Experience Relapse, Day 360 (D60) |
10 | — |
| SECONDARY Number of Participants Who Experience Non-relapse Mortality, Day 360 (D90) |
4 | — |
| SECONDARY Number of Participants Who Experience Non-relapse Mortality, Day 360 (D60) |
4 | — |
Eligibility 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 3 months ago
- Left ventricular ejection fraction (LVEF) >= 35%, or shortening fraction > 25%
- Bilirubin = 40% of predicted; if unable to perform pulmonary function testing, oxygen saturation > 92% on room air
- ECOG performance 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
Data sourced from ClinicalTrials.gov (NCT02556931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.