NCT01596257 · REGISTRY CONDITION SEARCH

Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2022-12-29

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Median Time to Engraftment of Neutrophils

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outcome · POSTED

Number of Participants Assessed for Toxicities

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outcome · POSTED

Median Time to Platelet Engraftment

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outcome · POSTED

Overall Survival

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outcome · POSTED

Hematopoietic Function on Day 30

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outcome · POSTED

Hematopoietic Function on Day 180

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outcome · POSTED

Hematopoietic Function on Day 360

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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 \< 75 years old. * Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status \> 70% * Patients must have adequate organ function measured by: * Cardiac: asymptomatic or if symptomatic then LVEF at rest must be \> 40% * Hepatic: \< 5x ULN ALT and \< 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia. * Renal: serum creatinine \<1.5 mg/dl or if serum creatinine is outside the normal range, then CrCl \> 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
healthy Volunteers: true
maximum Age: 75 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months
intervention Names
Procedure: allogeneic hematopoietic stem cell transplantation
Device: CliniMACS
label
bulk SCT
type
ACTIVE_COMPARATOR
description
Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months
intervention Names
Procedure: allogeneic hematopoietic stem cell transplantation
Device: CliniMACS
label
fractionated SCT
type
EXPERIMENTAL

interventions

arm Group Labels
bulk SCT
fractionated SCT
description
Undergo allogeneic hematopoietic stem cell transplant
name
allogeneic hematopoietic stem cell transplantation
type
PROCEDURE
arm Group Labels
bulk SCT
fractionated SCT
name
CliniMACS
type
DEVICE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 116
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Determine the effects of fractionated vs. bulk stem cell infusions on neutrophil recovery as defined by number of days with an absolute neutrophil count of less than 500 neutrophils per micro liter and time to an absolute neutrophil count (ANC) of 500. Determing the median time to ANC of \>/= 0.5 x 10\^9/L
measure
Median Time to Engraftment of Neutrophils
time Frame
Up to 100 weeks

secondary Outcomes

description
Participants will be assessed for toxicities with the NCI-Common Terminology for Adverse Events (CTCAE), version 4.0.
measure
Number of Participants Assessed for Toxicities
time Frame
2 years
description
The area under the hematopoietic recovery curve for the factors: ALC, CD4, CD8, and platelet count. The area under the curve will be computed based on recordings at days 30, 60, 100, 180, 365. Determine days to platelet engraftment by platelet count.
measure
Median Time to Platelet Engraftment
time Frame
Up to 365 days
description
Percentage of participants alive at 24 months
measure
Overall Survival
time Frame
24 months
description
Determine the difference of CD4+ lymphocyte recovery between the two arms on day 30
measure
Hematopoietic Function on Day 30
time Frame
30 days
description
Determine the difference of CD4+ lymphocyte recovery between the two arms on day 180
measure
Hematopoietic Function on Day 180
time Frame
180 days
description
Determine the difference of CD4+ lymphocyte recovery between the two arms on day 360
measure
Hematopoietic Function on Day 360
time Frame
360 days

Full study description

brief 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.
detailed Description: This is a complex study that involves various interventions, Intervention #1: Donor Initial Stem Cell Collection; Intervention #2: Stem Cell Product Initial Processing Orders; Intervention #3 Patient Admission and Transplantation; Intervention #4: Stem cell infusion; Intervention #5: Post infusion follow up; Intervention #6: Off Study Patient and Donor Evaluation. Patients whose donor fails to collect the appropriate number of cells will receive all their cells as a bulk infusion. These patients will continue to receive a transplant on protocol but will be replaced until both arms have reached the target accrual.

Source references