Leukemia, Myeloid, ChronicNCT00167167
Donor Lymphocyte Infusion (DLI) for Relapsed (Post Transplant) Leukemia
A study testing Donor Lymphocyte Infusion in people with Leukemia, Myeloid, Chronic and AML, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
In this study our hypothesis is that infusion of donor lymphocyte immune cells from the subject's bone marrow donor will activate the subject's immune system to attack their cancer. Read more about this study
- Who is it for?
- Ages 1 year to 60 years
- Conditions the study is for
- Leukemia, Myeloid, Chronic, AML, MDS
- What is being tested?
- Donor Lymphocyte Infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1995to Jan 2006
- 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 1 year to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with CML, AML, MDS or ALL relapsed after related or unrelated donor allogeneic marrow transplantation.
- Patients must be within one year of identification of relapse or if beyond that time period, must have some evidence of donor DNA by RFLP or cytogenetics.
- Patients may have evidence of relapse based on molecular, cytogenetic or morphologic criteria.
- CML patients must have cytogenetic evidence of relapse or if Ph negative to start, obvious evidence of relapse other than minimal residual disease.
- Patients must have <30% marrow blasts on a marrow biopsy performed within two weeks of the first donor lymphocyte infusion.
- Patients with >30% blasts can become eligible for donor lymphocytes after reinduction with any standard therapy regimen.
- Patients with AML, MDS or ALL achieving a CR with standard therapy regimens are eligible for this protocol.
- Patients who relapse with their initial disease or develop a second malignancy after related or unrelated donor allogeneic marrow transplantation with other initial diagnoses (such as but not limited to CLL, lymphoma, myeloma, juvenile CML, sarcoma, breast cancer) may also be included in this protocol. Patients will be eligible with or without other adjunct chemotherapy or radiation therapy. Post-transplant lymphomas (often referred to as EBV-associated lymphomas) will be eligible for donor leukocyte infusions on this protocol. Treatment with donor leukocytes under this protocol is restricted to malignant diseases only. Graft failure or relapse of non-malignant disorders is excluded from receiving donor leukocyte infusions on this protocol. Autologous transplant patients who relapse are not eligible for this protocol. Patients with malignant diseases amenable to other curative therapy are not eligible (i.e. skin cancers).
Who cannot join
- Patients with concurrent signs of acute or chronic graft-versus-host disease requiring ongoing treatment at the time of relapse will be ineligible.
- Patients with >30% marrow blasts at the time of therapy will be ineligible.
- Patients on prednisone, cyclosporine, Imuran or other immunosuppressive medications are not eligible until these medications are discontinued for at least 2 weeks without a flare of GVHD.
- CML patients in complete cytogenetic remission who are bcr/abl positive by PCR only are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
Official title: Treatment of Relapsed Leukemia After Allogeneic Bone Marrow Transplantation Using Donor-derived Lymphocytes
In this study our hypothesis is that infusion of donor lymphocyte immune cells from the subject's bone marrow donor will activate the subject's immune system to attack their cancer.
Read the detailed description
We will collect immune cells or lymphocytes from the donor's blood using a cell separator. The blood lymphocytes will be given to the subjects through a catheter. If the subjects have no complications of the first course of infusions, we may decide to give them "lymphocytes" aa second time while subjects are in remission in an attempt to prevent their disease from relapsing. A bone marrow test will be taken prior to infusion of lymphocytes as part of the clinical evaluation to receive this treatment. After lymphocyte infusions, a bone marrow will be examined about every three months for the first year to monitor progress from this therapy.
- Conditions
- Leukemia, Myeloid, Chronic, AML, MDS, Leukemia, Lymphocytic, Acute
- Being tested
- Donor Lymphocyte Infusion
- Keywords
- Donor Lymphocyte Infusion, relapse, post-transplant
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donor Lymphocyte InfusionProcedure or surgery
Certain immune cells in your donor's blood called "lymphocytes" have been shown to fight cancer after bone marrow transplantation. We plan to transfuse large numbers of donor's "lymphocytes" in the hope of activating the recipient's immune system to attack cancer.
| Study group | Role | What they receive |
|---|---|---|
| BMT patients | Experimental | All patients treated. Receives: Procedure: Donor Lymphocyte Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom of Disease: Bone marrow histology, cytogenetic analysis and RFLP will be studied. Data will be collected and tabulated.
Measured: before, at 3 months, 6 months, 9 months and 12 months after donor lymphocyte infusions
Secondary outcomes (4)
Toxicity
Measured: during the infusion and immediately thereafter
All data concerning acute toxicity including allergic reactions, capillary leak syndrome, and other Grade 4 toxicity will be collected and tabulated.
Measured: during the infusion,immediately thereafter, and at 1 month, 3 months, 6 months, 9 months, 1 year and yearly.
Graft-versus-host disease will be staged using criteria routinely used in allogeneic bone marrow transplant settings and will be tabulated.
Measured: ongoing
Marrow Aplasia including duration, treatment and outcomes.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startDec 1995
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, ChronicStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Investigators
- Jeffrey Miller, MD, Principal investigator, University of Minnesota Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167167
- Sponsor's protocol ID
- 9510M10277
- Other IDs
- MT1995-24, 1996LS146
- Status last verified
- Nov 2017
- First submitted
- 9 Sep 2005
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Relapsed Leukemia After Allogeneic Bone Marrow Transplantation Using Donor-derived Lymphocytes
- ClinicalTrials.gov ID
- NCT00167167
- Acronym / sponsor ID
- 9510M10277
- Conditions
- Leukemia, Myeloid, Chronic, AML, MDS, Leukemia, Lymphocytic, Acute
- Keywords
- Donor Lymphocyte Infusion, relapse, post-transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Dec 1995
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 14 Sep 2005 (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.
In this study our hypothesis is that infusion of donor lymphocyte immune cells from the subject's bone marrow donor will activate the subject's immune system to attack their cancer.
Detailed description
We will collect immune cells or lymphocytes from the donor's blood using a cell separator. The blood lymphocytes will be given to the subjects through a catheter. If the subjects have no complications of the first course of infusions, we may decide to give them "lymphocytes" aa second time while subjects are in remission in an attempt to prevent their disease from relapsing. A bone marrow test will be taken prior to infusion of lymphocytes as part of the clinical evaluation to receive this treatment. After lymphocyte infusions, a bone marrow will be examined about every three months for the first year to monitor progress from this therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMT patients | Experimental | Procedure: Donor Lymphocyte InfusionAll patients treated. |
Who may qualify
- Ages
- 1 year to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Patients with CML, AML, MDS or ALL relapsed after related or unrelated donor allogeneic marrow transplantation.
- Patients must be within one year of identification of relapse or if beyond that time period, must have some evidence of donor DNA by RFLP or cytogenetics.
- Patients may have evidence of relapse based on molecular, cytogenetic or morphologic criteria.
- CML patients must have cytogenetic evidence of relapse or if Ph negative to start, obvious evidence of relapse other than minimal residual disease.
- Patients must have <30% marrow blasts on a marrow biopsy performed within two weeks of the first donor lymphocyte infusion.
Key exclusion criteria (4 listed)
- Patients with concurrent signs of acute or chronic graft-versus-host disease requiring ongoing treatment at the time of relapse will be ineligible.
- Patients with >30% marrow blasts at the time of therapy will be ineligible.
- Patients on prednisone, cyclosporine, Imuran or other immunosuppressive medications are not eligible until these medications are discontinued for at least 2 weeks without a flare of GVHD.
- CML patients in complete cytogenetic remission who are bcr/abl positive by PCR only are not eligible.
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 |
|---|---|---|
| Donor Lymphocyte InfusionCertain immune cells in your donor's blood called "lymphocytes" have been shown to fight cancer after bone marrow transplantation. We plan to transfuse large numbers of donor's "lymphocytes" in the hope of activating the recipient's immune system to attack cancer. | Procedure or surgery | BMT patients |
Primary outcome
Freedom of Disease: Bone marrow histology, cytogenetic analysis and RFLP will be studied. Data will be collected and tabulated.
Time frame: before, at 3 months, 6 months, 9 months and 12 months after donor lymphocyte infusions
4 secondary outcomes
Toxicity
Time frame: during the infusion and immediately thereafter
All data concerning acute toxicity including allergic reactions, capillary leak syndrome, and other Grade 4 toxicity will be collected and tabulated.
Time frame: during the infusion,immediately thereafter, and at 1 month, 3 months, 6 months, 9 months, 1 year and yearly.
Graft-versus-host disease will be staged using criteria routinely used in allogeneic bone marrow transplant settings and will be tabulated.
Time frame: ongoing
Marrow Aplasia including duration, treatment and outcomes.
Time frame: ongoing
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 29 Nov 2017.
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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.
Jeffrey Miller, MD principal investigator
University of Minnesota Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Donor Lymphocyte Infusion in people with Leukemia, Myeloid, Chronic and AML, run by Masonic Cancer Center, University of Minnesota 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 8 inclusion and 4 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 29 Nov 2017. 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?
Freedom of Disease: Bone marrow histology, cytogenetic analysis and RFLP will be studied. Data will be collected and tabulated. (time frame: before, at 3 months, 6 months, 9 months and 12 months after donor lymphocyte infusions). 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 29 Nov 2017.