Acute Myelogenous LeukemiaNCT00038870
Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes
A study testing Dendritic Cell Activated Lymphocyte in people with Acute Myelogenous Leukemia and Chronic Myelogenous Leukemia, run by M.D. Anderson Cancer Center.
Trial summary
1. Determine the feasibility of generation of autologous Acute Myelogenous Leukemia (AML) or Chronic Myelogenous Leukemia in myeloid blast crisis (CML/BC) derived dendritic cell activated lymphocytes (DC/AL) in poor prognosis patients. 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia
- What is being tested?
- Dendritic Cell Activated Lymphocyte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2001to 14 Jan 2003
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AML patients either after first relapse or at diagnosis a) with high-risk cytogenetics such as -7, -5, +8, chromosome 9 or 11 abnormality, or b) WBC > 50,000, or c) age > 60 years*.
- AML patients are eligible for cell collection if they have > 1000 circulating blasts/mm at diagnosis.
- CML patients in myeloid blast crisis with > 1000 circulating blasts/mm.
- Creatinine <2, Bilirubin <3.
- Age >18.
Who cannot join
- Factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
- Concurrent or expected need for therapy with corticosteroids.
- Positive antibody to human immunodeficiency virus I.
- Acute promyelocytic Leukemia (FAB-M3).
- History of overt cardiac failure, systemic autoimmune disease or expected need for steroid therapy.
- Patients >60 will be eligible for study but if found to have good prognosis cytogenetics (inversion (16) or t(8;21)) will subsequently be withdrawn from study and treated off protocol without infusion of autologous leukemia derived cells.
About this study
- Determine the feasibility of generation of autologous Acute Myelogenous Leukemia (AML) or Chronic Myelogenous Leukemia in myeloid blast crisis (CML/BC) derived dendritic cell activated lymphocytes (DC/AL) in poor prognosis patients.
- Determine the toxicity of autologous leukemia derived dendritic cell activated lymphocytes (DC/AL) in patients with AML or CML/BC.
- Quantitate circulating immune effector cells in patients after infusion of DC/AL.
- Record the efficacy of AML or CML/BC derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with AML or CML/BC.
Read the detailed description
Most patients relapsing with AML either fail to achieve second remission or have only brief remissions. Patients more than 60 years of age or having histories of antecedent hematological disorders, prior chemotherapy, or poor risk cytogenetics have generally only short remissions and as a group have two year survivals of less than 10%. Equally patients with myeloid blast crisis of CML often fail to achieve remission or have responses of only brief duration. Laboratory studies have shown that AML leukemic blasts may be induced in culture to differentiate into dendritic cells which in turn may be used activate autologous lymphocytes to acquire leukemia specific cytotoxicity. This trial will assess the feasibility of generation of dendritic cell activated lymphocytes, and toxicity and efficacy of these activated cells given after reinduction chemotherapy. Before this study begins some toxicity information will have been generated in a trial of similar cells given to CML patients.
- Being tested
- Dendritic Cell Activated Lymphocyte
- Keywords
- AML, CML, Dendritic Cells
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendritic Cell Activated LymphocyteBiological
Also called autologous leukemia derived dendritic cell activated lymphocytes, DC/AL
| Study group | Role | What they receive |
|---|---|---|
| Dendritic Cell Activated Lymphocytes | Experimental | Not described Receives: Biological: Dendritic Cell Activated Lymphocyte |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2002 (estimated)
- Study start31 Jan 2001
- Primary completion14 Jan 2003
- Study completion14 Jan 2003
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 Acute Myelogenous LeukemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Immunex Corporation, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Richard Champlin, MD,BS, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038870
- Sponsor's protocol ID
- ID99-075
- Status last verified
- Oct 2018
- First submitted
- 5 Jun 2002
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy of Relapsed AML With Chemotherapy and Dendritic Cell Activated Lymphocytes
- ClinicalTrials.gov ID
- NCT00038870
- Acronym / sponsor ID
- ID99-075
- Keywords
- AML, CML, Dendritic Cells
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow accrual.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Immunex Corporation, National Cancer Institute (NCI)
- Study start
- 31 Jan 2001 (actual)
- Primary completion
- 14 Jan 2003 (actual)
- Study completion
- 14 Jan 2003 (actual)
- First posted
- 7 Jun 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.
- Determine the feasibility of generation of autologous Acute Myelogenous Leukemia (AML) or Chronic Myelogenous Leukemia in myeloid blast crisis (CML/BC) derived dendritic cell activated lymphocytes (DC/AL) in poor prognosis patients.
- Determine the toxicity of autologous leukemia derived dendritic cell activated lymphocytes (DC/AL) in patients with AML or CML/BC.
- Quantitate circulating immune effector cells in patients after infusion of DC/AL.
- Record the efficacy of AML or CML/BC derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with AML or CML/BC.
Detailed description
Most patients relapsing with AML either fail to achieve second remission or have only brief remissions. Patients more than 60 years of age or having histories of antecedent hematological disorders, prior chemotherapy, or poor risk cytogenetics have generally only short remissions and as a group have two year survivals of less than 10%. Equally patients with myeloid blast crisis of CML often fail to achieve remission or have responses of only brief duration. Laboratory studies have shown that AML leukemic blasts may be induced in culture to differentiate into dendritic cells which in turn may be used activate autologous lymphocytes to acquire leukemia specific cytotoxicity. This trial will assess the feasibility of generation of dendritic cell activated lymphocytes, and toxicity and efficacy of these activated cells given after reinduction chemotherapy. Before this study begins some toxicity information will have been generated in a trial of similar cells given to CML patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dendritic Cell Activated Lymphocytes | Experimental | Biological: Dendritic Cell Activated Lymphocyte |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- AML patients either after first relapse or at diagnosis a) with high-risk cytogenetics such as -7, -5, +8, chromosome 9 or 11 abnormality, or b) WBC > 50,000, or c) age > 60 years*.
- AML patients are eligible for cell collection if they have > 1000 circulating blasts/mm at diagnosis.
- CML patients in myeloid blast crisis with > 1000 circulating blasts/mm.
- Creatinine <2, Bilirubin <3.
- Age >18.
Key exclusion criteria (6 listed)
- Factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
- Concurrent or expected need for therapy with corticosteroids.
- Positive antibody to human immunodeficiency virus I.
- Acute promyelocytic Leukemia (FAB-M3).
- History of overt cardiac failure, systemic autoimmune disease or expected need for steroid therapy.
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 |
|---|---|---|
| Dendritic Cell Activated LymphocyteAlso: autologous leukemia derived dendritic cell activated lymphocytes, DC/AL | Biological | Dendritic Cell Activated Lymphocytes |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
Richard Champlin, MD,BS principal investigator
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Dendritic Cell Activated Lymphocyte in people with Acute Myelogenous Leukemia and Chronic Myelogenous Leukemia, run by M.D. Anderson Cancer Center.
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 5 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: withdrawn, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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.
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 2018.