Phase 2
N=116
Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01596257 ↗Enrolled (actual)
116
Serious AEs
28.4%
Results posted
Dec 2022
Primary outcome: Primary: Median Time to Engraftment of Neutrophils — 11; 11 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- allogeneic hematopoietic stem cell transplantation (Procedure); CliniMACS (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Time to Engraftment of Neutrophils |
11; 11 | — |
| SECONDARY Number of Participants Assessed for Toxicities |
38; 36; 23; 19 | — |
| SECONDARY Median Time to Platelet Engraftment |
18; 18 | — |
| SECONDARY Overall Survival |
60; 62 | — |
| SECONDARY Hematopoietic Function on Day 30 |
0; 6 | — |
| SECONDARY Hematopoietic Function on Day 180 |
179; 111 | — |
| SECONDARY Hematopoietic Function on Day 360 |
294; 280 | — |
Summary
The purpose of this study is to find out if getting a blood stem cell transplant with donor stem cells given over several days is better than getting a blood stem cell transplant with donor stem cells given over 1 day. We want to find out which procedure over will result in improved recovery of blood and immune function after transplant. When donor stem cells are given over various days in mice, the blood and immune system recovery is quicker.
Eligibility Criteria
Inclusion Criteria
- Patients who are considered candidates for an allogeneic stem cell transplantation as treatment for any of the following hematologic disorders:
- Acute Leukemia
- Myelodysplastic syndrome
- Other myeloproliferative disorder (i.e. myelofibrosis, chronic myelomonocytic leukemia, or chronic myelogenous leukemia)
- Non Hodgkins Lymphoma
- Hodgkins Disease
- Multiple Myeloma
- Age includes from birth to 70%
- Patients must have adequate organ function measured by:
- Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > 40%
- Hepatic: 40 ml/min (measured or calculated/estimated)
- Pulmonary: asymptomatic or if symptomatic, DLCO > 40% of predicted (corrected for hemoglobin).
Exclusion Criteria
- Female patients who are pregnant or breast-feeding.
- Active viral, bacterial or fungal infection
- Patient seropositive for HIV-I/II; HTLV -I/II
- Presence of leukemia in the CNS
- Candidate for a protocol of higher priority. For the purpose of this study, the following protocols will be considered of higher priority: 10-051
Donor Inclusion Criteria:
- HLA compatible related or unrelated donor, (i.e. a fully matched unmanipulated grafts or 1-2 HLA allele disparate donor for CD34 selected grafts).
- Meets criteria outlined in the FACT-approved SOP for "DONOR EVALUATION AND SELECTION FOR ALLOGENEIC TRANSPLANTATION" in the Blood and Marrow Transplant Program Manual, document E-1 see http://mskweb5.mskcc.org/intranet/html/80312.cfm
- Donor must have adequate peripheral venous catheter access for leukapheresis or must agree to placement of a central catheter.
- Wt >25kg
Donor Exclusion Criteria:
- Evidence of active infection (including urinary tract infection, or upper respiratory tract Infection) or viral hepatitis exposure (on screening), unless only HBS Ab+ and HBV DNA negative.
- Medical or physical reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis.
- Factors which place the donor at increased risk for complications from leukapheresis or GCSF therapy (e.g., autoimmune disease, sickle cell trait, symptomatic coronary artery disease requiring therapy).
- Pregnancy (positive serum or urine β-HCG) or breastfeeding. Women of childbearing age must avoid becoming pregnant while on the study
Data sourced from ClinicalTrials.gov (NCT01596257). 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.