Malignant Diseases (ie, Leukemia, MDS, Lymphoma)NCT01071226
Peripheral Blood Stem Cell Transplantation Using the CliniMACS Device
A study testing CliniMACS (CD+3, CD+19 depletion), CliniMACS (CD 34+ positive selection) and HSCT in people with Malignant Diseases (ie, Leukemia, MDS, Lymphoma) and Non-malignant Diseases (ie, Bone Marrow Failure Syndromes), run by Medical College of Wisconsin at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 22 years
- Conditions the study is for
- Malignant Diseases (ie, Leukemia, MDS, Lymphoma), Non-malignant Diseases (ie, Bone Marrow Failure Syndromes)
- What is being tested?
- CliniMACS (CD+3, CD+19 depletion), CliniMACS (CD 34+ positive selection) and HSCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to 28 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All races are eligible
- Malignant diseases: Leukemias and Lymphomas
- Non-malignant diseases: Severe Aplastic Anemia, immunodeficiencies
Who cannot join
- Lansky or Karnofsky > 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: AST and ALT < 3x upper limit of normal; bilirubin < 2.0.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With The CliniMACS Device for T and B Cell Depletion
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).
- Conditions
- Malignant Diseases (ie, Leukemia, MDS, Lymphoma), Non-malignant Diseases (ie, Bone Marrow Failure Syndromes)
- Being tested
- CliniMACS (CD+3, CD+19 depletion), CliniMACS (CD 34+ positive selection), HSCT
- Keywords
- Malignant and non-malignant diseases, Hematopoietic stem cell transplant, Peripheral blood progenitor cell transplant, CliniMACS device, T cell depletion
- Medical subject headings
- Leukemia, Lymphoma, Bone Marrow Failure Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CliniMACS (CD+3, CD+19 depletion)Device
Patient's in Stratum 1 will receive grafts that have undergone CD3+, CD19+ depletion
CliniMACS (CD 34+ positive selection)Device
Patient's in Stratum 2 will receive peripheral blood progenitor cells that have undergone CD34+ selection
HSCTOther
Peripheral Blood Stem Cell Transplant
| Study group | Role | What they receive |
|---|---|---|
| Stratum 1 | Experimental | Patients receiving an unrelated donor or partially matched related donor. Receives: Device: CliniMACS (CD+3, CD+19 depletion); Other: HSCT |
| Stratum 2 | Experimental | For the patient's whose donors are haploidentical or a 2 antigen mismatched where one of the mismatches includes DRB1 Receives: Device: CliniMACS (CD 34+ positive selection); Other: HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the incidence and quality of engraftment
Measured: 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.
Measured: weekly for the first 100 days and then 6 and 12 months post transplant date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startMay 2008
- Primary completionAug 2016
- Study completion28 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Diseases (ie, Leukemia, MDS, Lymphoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, Julie-An M. Talano, Medical College of Wisconsin
- Investigators
- Julie A Talano, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071226
- Sponsor's protocol ID
- CHOP 07/216
- Status last verified
- Oct 2021
- First submitted
- 17 Feb 2010
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHP 834 Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With The CliniMACS Device for T and B Cell Depletion
- ClinicalTrials.gov ID
- NCT01071226
- Acronym / sponsor ID
- CHOP 07/216
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- May 2008
- Primary completion
- Aug 2016 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 19 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stratum 1 | Experimental | Device: CliniMACS (CD+3, CD+19 depletion), Other: HSCTPatients receiving an unrelated donor or partially matched related donor. |
| Stratum 2 | Experimental | Device: CliniMACS (CD 34+ positive selection), Other: HSCTFor the patient's whose donors are haploidentical or a 2 antigen mismatched where one of the mismatches includes DRB1 |
Who may qualify
- Ages
- Up to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- All races are eligible
- Malignant diseases: Leukemias and Lymphomas
- Non-malignant diseases: Severe Aplastic Anemia, immunodeficiencies
Key exclusion criteria (6 listed)
- Lansky or Karnofsky > 70
- Echo > 27% shortening fraction
- renal function:serum creatinine < 1.5 x for normal age
- no active untreated infection
- DLCO > 50% of predicted value
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CliniMACS (CD+3, CD+19 depletion)Patient's in Stratum 1 will receive grafts that have undergone CD3+, CD19+ depletion | Device | Stratum 1 |
| CliniMACS (CD 34+ positive selection)Patient's in Stratum 2 will receive peripheral blood progenitor cells that have undergone CD34+ selection | Device | Stratum 2 |
| HSCTPeripheral Blood Stem Cell Transplant | Other | Stratum 1, Stratum 2 |
Primary outcome
To measure the incidence and quality of engraftment
Time frame: Weekly for first 100 days, 6 months and 1 year
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A Talano, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CliniMACS (CD+3, CD+19 depletion), CliniMACS (CD 34+ positive selection) and HSCT in people with Malignant Diseases (ie, Leukemia, MDS, Lymphoma) and Non-malignant Diseases (ie, Bone Marrow Failure Syndromes), run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the incidence and quality of engraftment (time frame: Weekly for first 100 days, 6 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.