ClinicalTrials.gg
CompletedNCT01071226Updated Oct 25, 2021

Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device

An interventional study of CliniMACS (CD+3, CD+19 depletion) and CliniMACS (CD 34+ positive selection) in Malignant Diseases (ie, Leukemia, MDS, Lymphoma) and Non-malignant Diseases (ie, Bone Marrow Failure Syndromes), sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged Up to 22 Years. Per ClinicalTrials.gov, last updated 2021-10-25.

Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
Up to 22 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Leukemia by Medical College of Wisconsin — 2 open to participants now, 2 under way, none of them phase 3. Leukemia · Medical College of Wisconsin.

Enrollment
5th of 10
60 · median 51
Started
2008
the only one that year
No phase
2 of 10
1 open now
Registered
4th of 10
by date

Among the 10 studies in Leukemia by Medical College of Wisconsin, this one is the 5th largest by enrollment, is the only one that started in 2008, is one of 2 with no phase, and was the 4th registered.

Leukemia

2,381 studies on the registry are indexed under Leukemia; 253 are open to participants now.

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Open to participants now

2 of the 10 studies in Leukemia by Medical College of Wisconsin are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 208 Leukemia studies recruiting now, 112 (54%) set no upper age limit and 74 (36%) stop at 75 or younger; 86 take children under 18; 24 take healthy volunteers.

This study: Up to 22 Years · all sexes · no healthy volunteers.

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02

Study summary

T cell depletion utilizing the CliniMACS device will allow more precise, specific and controlled graft engineering of peripheral blood stem cells from unrelated and partially matched related donors without an increase in relapse or graft rejection and grade III or IV acute graft versus host disease (GVHD).

03

Conditions studied

  • Malignant Diseases (ie, Leukemia, MDS, Lymphoma)
  • Non-malignant Diseases (ie, Bone Marrow Failure Syndromes)

Keywords

  • Malignant and non-malignant diseases
  • Hematopoietic stem cell transplant
  • Peripheral blood progenitor cell transplant
  • CliniMACS device
  • T cell depletion
04

Who can participate

Ages eligible
Up to 22 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All races are eligible
  • Malignant diseases: Leukemias and Lymphomas
  • Non-malignant diseases: Severe Aplastic Anemia, immunodeficiencies

Exclusion criteria

Exclusion Criteria:

  • Lansky or > 70
  • Echo > 27% shortening fraction
  • renal function:serum creatinine \< 1.5 x for normal age
  • no active untreated infection
  • DLCO > 50% of predicted value
  • Hepatic: and ALT \< 3x ; \< 2.0.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Stratum 1

    Patients receiving an unrelated donor or partially matched related donor.

    Device: CliniMACS (CD+3, CD+19 depletion) · Other: HSCT

  • Experimental
    Stratum 2

    For the patient's whose donors are haploidentical or a 2 antigen mismatched where one of the mismatches includes DRB1

    Device: CliniMACS (CD 34+ positive selection) · Other: HSCT

Interventions

  • DeviceCliniMACS (CD+3, CD+19 depletion)

    Patient's in Stratum 1 will receive grafts that have undergone CD3+, CD19+ depletion

  • DeviceCliniMACS (CD 34+ positive selection)

    Patient's in Stratum 2 will receive peripheral blood progenitor cells that have undergone CD34+ selection

  • OtherHSCT

    Peripheral Blood Stem Cell Transplant

06

What researchers measure

Primary outcomes

  1. To measure the incidence and quality of engraftment

    Time frame: Weekly for first 100 days, 6 months and 1 year

Secondary outcomes

  1. Evaluate the incidence of acute Graft versus Health Disease and treatment related mortality.

    Time frame: weekly for the first 100 days and then 6 and 12 months post transplant date

07

Study locations

1 site
  • Children's Hospital of Wisconsin
    Milwaukee, Wisconsin 53226, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2008, a primary completion of Aug 2016 and a completion of Apr 2020. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 17, 2010
First posted
Feb 19, 2010
Start
May 2008
Primary completionActual
Aug 2016
CompletionActual
Apr 28, 2020
Results delay requested
Mar 22, 2018
Last update
Oct 25, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01071226
Responsible party
Julie-An M. Talano (Associate Professor of Pediatrics and Director of Clinical Pediatric BMT Research, Medical College of Wisconsin) — Principal investigator
First posted
Feb 19, 2010
Start date
May 2008
Primary completion
Aug 2016
Completion
Apr 28, 2020
Last update
Oct 25, 2021

Study contacts

Julie A Talano, MD
principal investigator · Medical College of Wisconsin

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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