Chronic Myelogenous LeukemiaNCT00038818
CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation
A study testing CD8 Depleted Donor Lymphocyte in people with Chronic Myelogenous Leukemia and Multiple Myeloma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: To evaluate response rates of acute or chronic Graft-versus-host disease (GVHD) following CD8 depleted DLI (Depleted Donor Lymphocyte Infusions) in patients with Chronic myelomonocytic leukemia (CMML), chronic lymphoid leukemia (CLL), Non-Hodgkin's lymphoma (NLM), Multiple Myeloma (MM) and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Myelogenous Leukemia, Multiple Myeloma, Non Hodgkin's Lymphoma
- What is being tested?
- CD8 Depleted Donor Lymphocyte
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- May 2001to Dec 2002
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- Patients of any age who have previously undergone allogeneic hematopoietic transplantation and have evidence of donor cell engraftment (>20% donor cell within three months of study entry)
- Expected survival >4 weeks
- CML patients with molecular, cytogenetic or hematologic relapse following allogeneic transplantation
- Molecular relapse- patients are eligible if bcr/abl is detectable at any time after day 180 post-allogeneic transplantation or if a negative bcr/abl PCR test was documented post-transplantation and the bcr/abl test is now positive by consecutive PCR determinations at least 4 weeks apart.
- Cytogenetic relapse-patients are eligible if standard cytogenetics demonstrate >10% t (9,22) positive cells greater than 60 days after myeloablative transplantation or 10% t (9,22) positive cells greater than 100 days after nonmyeloablative transplantation.
- CML patients with accelerated phase or blast crisis following allogeneic transplantation
- Patients with CLL, NHL, MM, or HD who have evidence of disease relapse or persistent disease at 60 days post-allo BMT and/or:
- MM- patients with a rising M-protein is detectable at 180 days post-transplant
- NHL - patients with molecular evidence of disease (bcl-2, t (4,11), etc.) at 180 days post transplant
- CLL, NHL or HD - patients with clear cut evidence of tumor growth at any time post-transplant are eligible
- Patients undergoing an HLA -identical or 5/6 antigen match transplant from a related or unrelated donor
- Patient's original donor must be available for lymphocyte donation
- There must be no evidence of active acute or graft-versus-host disease and patients should be off all immunosuppressive agents for, at least, two weeks prior to DLI. Patients on stable dose of methylprednisolone (<16 mg/d) without evidence of active GVHD are also eligible.
- Patients must have a Zubrod PS<2 (see appendix 7), Cr<2.5, bilirubin <3, and transaminases (SGPT, SGOT) <4x normal
- Patient must be able to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation
Primary Objectives:
To evaluate response rates of acute or chronic Graft-versus-host disease (GVHD) following CD8 depleted DLI (Depleted Donor Lymphocyte Infusions) in patients with Chronic myelomonocytic leukemia (CMML), chronic lymphoid leukemia (CLL), Non-Hodgkin's lymphoma (NLM), Multiple Myeloma (MM) and Hodgkin's Lymphoma (HD).
Read more
Secondary Objectives:
- To evaluate safety and treatment related mortality after CD8 depleted DLI.
- To evaluate the time to onset of GVHD following DLI and response to GVHD treatment.
- To evaluate the incidence and timing of pancytopenia following DLI.
- To evaluate disease-free survival, overall survival and relapse rates in three cohorts of patients; early relapse CML, late relapse CML and lymphoproliferative disorders (HD, CLL, NHL and MM).
- To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte infusions.
- To evaluate the number of apheresis procedures needed to collect appropriate doses of CD4+ cells.
- Conditions
- Chronic Myelogenous Leukemia, Multiple Myeloma, Non Hodgkin's Lymphoma, Hodgkin's Disease, Chronic Lymphocytic Leukemia
- Being tested
- CD8 Depleted Donor Lymphocyte
- Keywords
- CML, MM, NHL, HD, CLL, CD8 Depleted, Donor Lymphocyte
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Multiple Myeloma, Lymphoma, Non-Hodgkin, Hodgkin Disease, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD8 Depleted Donor LymphocyteBiological
| Study group | Role | What they receive |
|---|---|---|
| CD8 DLI | Experimental | CD8 depleted DLI (Depleted Donor Lymphocyte Infusions) Receives: Biological: CD8 Depleted Donor Lymphocyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Response Rates of Acute or Chronic GVHD
Measured: 2 years
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 startMay 2001
- Primary completionDec 2002
- Study completionDec 2002
Why it stopped: Low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eligix
- Responsible party
- Sponsor
- Investigators
- Richard Champlin, MD, BS, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038818
- Sponsor's protocol ID
- ID00-335
- Status last verified
- Aug 2012
- First submitted
- 5 Jun 2002
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00038818
- Acronym / sponsor ID
- ID00-335
- Conditions
- Chronic Myelogenous Leukemia, Multiple Myeloma, Non Hodgkin's Lymphoma, Hodgkin's Disease, Chronic Lymphocytic Leukemia
- Keywords
- CML, MM, NHL, HD, CLL, CD8 Depleted, Donor Lymphocyte
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Eligix
- Study start
- May 2001
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2002 (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.
Primary Objectives:
To evaluate response rates of acute or chronic Graft-versus-host disease (GVHD) following CD8 depleted DLI (Depleted Donor Lymphocyte Infusions) in patients with Chronic myelomonocytic leukemia (CMML), chronic lymphoid leukemia (CLL), Non-Hodgkin's lymphoma (NLM), Multiple Myeloma (MM) and Hodgkin's Lymphoma (HD).
Secondary Objectives:
- To evaluate safety and treatment related mortality after CD8 depleted DLI.
- To evaluate the time to onset of GVHD following DLI and response to GVHD treatment.
- To evaluate the incidence and timing of pancytopenia following DLI.
- To evaluate disease-free survival, overall survival and relapse rates in three cohorts of patients; early relapse CML, late relapse CML and lymphoproliferative disorders (HD, CLL, NHL and MM).
- To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte infusions.
- To evaluate the number of apheresis procedures needed to collect appropriate doses of CD4+ cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD8 DLI | Experimental | Biological: CD8 Depleted Donor LymphocyteCD8 depleted DLI (Depleted Donor Lymphocyte Infusions) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| CD8 Depleted Donor Lymphocyte | Biological | CD8 DLI |
Primary outcome
Patient Response Rates of Acute or Chronic GVHD
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Low accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CD8 Depleted Donor Lymphocyte in people with Chronic Myelogenous Leukemia and Multiple Myeloma, 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.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2012. 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 was stopped early (reason given: Low 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?
Patient Response Rates of Acute or Chronic GVHD (time frame: 2 years). 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 23 Aug 2012.