Leukemia, Myelocytic, AcutePhase 1NCT00048100
Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes
A Phase 1 study testing Apheresis and Stem Cell Transplant in people with Leukemia, Myelocytic, Acute, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: 1. Determine the toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants. 2. Quantitate the alloreactivity of DC/ADL and circulating immune effector cells in patients after infusion. 3. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leukemia, Myelocytic, Acute
- What is being tested?
- Apheresis and Stem Cell Transplant
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to May 2005
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AML (any type except M3) or CIVIL in blast crisis with greater than or equal to 20% bone marrow blasts at the time of related donor marrow or stem cell transplantation or at relapse post transplant.
- Willing to undergo a skin biopsy and either a leukodepletion apheresis or an additional marrow aspiration.
- Stem cell or marrow donor willing to have apheresis for T-Cell collection.
- Written voluntary informed consent must be obtained from patient and donor.
Who cannot join
- Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
- AML French-American-British (FAB) subtype M3.
Trial locations and contacts
1 site in 1 country.
United States1 site
M.D. Anderson Cancer Center
Houston, Texas, 77030-4009
About this study
Official title: Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes for Therapy of Relapsed Leukemia After Allogeneic Stem Cell Therapy
Objectives:
- Determine the toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.
- Quantitate the alloreactivity of DC/ADL and circulating immune effector cells in patients after infusion.
- Assess efficacy of acute myelogenous leukemia (AML) or Chronic Myelogenous Leukemia in Blastic Crisis (CML-BC) derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with relapse after allo-BMT or stem cell transplant.
- Conditions
- Leukemia, Myelocytic, Acute
- Being tested
- Apheresis, Stem Cell Transplant
- Keywords
- Dendritic cells, Lymphocytes, AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApheresisProcedure or surgery
Apheresis for T-Cell collection
Stem Cell TransplantBiological
Also called SCT, Stem Cell Transplantation
Stem cell or marrow infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL).
| Study group | Role | What they receive |
|---|---|---|
| Apheresis + Transplant | Experimental | Skin biopsy \& either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation. Receives: Procedure: Apheresis; Biological: Stem Cell Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Toxicity Levels
Participant toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.
Measured: From stem cell transplant baseline to 30 plus days post transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2002 (estimated)
- Study startFeb 2001
- Primary completionMay 2005
- Study completionMay 2005
Why it stopped: Slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myelocytic, AcuteStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elizabeth J. Shpall, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048100
- Sponsor's protocol ID
- ID00-034
- Status last verified
- Oct 2018
- First submitted
- 24 Oct 2002
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes for Therapy of Relapsed Leukemia After Allogeneic Stem Cell Therapy
- ClinicalTrials.gov ID
- NCT00048100
- Acronym / sponsor ID
- ID00-034
- Conditions
- Leukemia, Myelocytic, Acute
- Keywords
- Dendritic cells, Lymphocytes, AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2001
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 25 Oct 2002 (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.
Objectives:
- Determine the toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.
- Quantitate the alloreactivity of DC/ADL and circulating immune effector cells in patients after infusion.
- Assess efficacy of acute myelogenous leukemia (AML) or Chronic Myelogenous Leukemia in Blastic Crisis (CML-BC) derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with relapse after allo-BMT or stem cell transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apheresis + Transplant | Experimental | Procedure: Apheresis, Biological: Stem Cell TransplantSkin biopsy \& either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AML (any type except M3) or CIVIL in blast crisis with greater than or equal to 20% bone marrow blasts at the time of related donor marrow or stem cell transplantation or at relapse post transplant.
- Willing to undergo a skin biopsy and either a leukodepletion apheresis or an additional marrow aspiration.
- Stem cell or marrow donor willing to have apheresis for T-Cell collection.
- Written voluntary informed consent must be obtained from patient and donor.
Key exclusion criteria (2 listed)
- Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
- AML French-American-British (FAB) subtype M3.
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 |
|---|---|---|
| ApheresisApheresis for T-Cell collection | Procedure or surgery | Apheresis + Transplant |
| Stem Cell TransplantAlso: SCT, Stem Cell TransplantationStem cell or marrow infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL). | Biological | Apheresis + Transplant |
Primary outcome
Participant Toxicity Levels
Time frame: From stem cell transplant baseline to 30 plus days post transplant.
Participant toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.
Results and safety
The study was stopped early (reason given: Slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Elizabeth J. Shpall, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Apheresis and Stem Cell Transplant in people with Leukemia, Myelocytic, Acute, run by M.D. Anderson Cancer Center 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 31 Oct 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow accrual.). Results are not available in the source record.
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?
Participant Toxicity Levels (time frame: From stem cell transplant baseline to 30 plus days post transplant.). 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 31 Oct 2018.