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Immunotherapy
NK Cell Enriched DLIs +/− TLR9 Agonist for Myeloid Leukemia (NK-DCI Trial)
Phase 2
Waitlist Available
Led By David A Rizzieri, MD
Research Sponsored by David Rizzieri, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age of >= 18 years.
Performance status must be ECOG PS 0, 1, or 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
NK-DCI Trial Summary
This trial will compare the rates of progression-free survival and unacceptable toxicity in patients receiving NK cell-enriched donor lymphocyte infusions (DLIs) with or without the TLR9 agonist, DUK-CPG-001.
Who is the study for?
Adults over 18 with myeloid leukemia, lymphoma, or tumors who've had a T-cell depleted transplant from an HLA-matched donor and are at risk of relapse. They should have minimal graft-versus-host disease and be stable on low-dose immunosuppression. Women must test negative for pregnancy and use birth control; men also need to use contraception post-infusion.Check my eligibility
What is being tested?
This phase II trial is testing whether NK cell-enriched donor lymphocyte infusions alone or combined with the TLR9 agonist DUK-CPG-001 improve progression-free survival after stem cell transplantation. Participants are grouped based on their HLA match level (7-8/8 or 4-6/8) and type of malignancy (myeloid vs lymphoid).See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever, fatigue, infusion-related symptoms, increased risk of infections due to immune modulation, and possibly worsening of graft-versus-host disease.
NK-DCI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I can take care of myself and perform daily activities.
NK-DCI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Unacceptable Toxicity
Progression-Free Survival (PFS) Rate
Secondary outcome measures
Immune Function Pre and Post-Infusion With Antigen Specific Recovery, as Measured by Elispot Assay
Immune Function Pre and Post-Infusion With Antigen Specific Recovery, as Measured by Flow-cytometric Cytokine Assay
Immune Function Pre and Post-Infusion With Antigen Specific Recovery, as Measured by Functional NK Lysis Assay
+2 moreNK-DCI Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Cohort B - NK-DLI + DUK-CPG-001Experimental Treatment1 Intervention
Patients with a 4-6/8 human leukocyte antigen (HLA)-matched related donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) and investigational DUK-CPG-001
Group II: Cohort A - NK-DLI + DUK-CPG-001Experimental Treatment1 Intervention
Patients with a 7-8/8 human leukocyte antigen (HLA)-matched related or unrelated donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) and investigational DUK-CPG-001
Group III: Cohort B - NK cell enriched-DLI onlyActive Control1 Intervention
Patients with a 4-6/8 human leukocyte antigen (HLA)-matched related donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) only
Group IV: Cohort A - NK cell enriched-DLI onlyActive Control1 Intervention
Patients with a 7-8/8 human leukocyte antigen (HLA)-matched related or unrelated donor receiving natural killer (NK) cell enriched donor lymphocyte infusion (DLI) only
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Who is running the clinical trial?
David Rizzieri, MDLead Sponsor
11 Previous Clinical Trials
602 Total Patients Enrolled
6 Trials studying Lymphoma
312 Patients Enrolled for Lymphoma
Cristina GasparettoLead Sponsor
2 Previous Clinical Trials
74 Total Patients Enrolled
Agilent Technologies, Inc.Industry Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My donor matches me closely in HLA type.My liver tests are within normal limits.My lab results are ready before my treatment, and if I donate again, they'll check my labs within 30 days.I am a woman who can have children and have a negative pregnancy test.I agree to use birth control during and for 3 months after the study.I do not have a high chance of responding well to a transplant based on my specific disease and treatment history.My donor matches 4-6 out of 8 HLA markers and meets current standards.I am 18 years old or older.I had a specific bone marrow transplant for my blood disease and my donor was a close match.I can take care of myself and perform daily activities.I am a donor match for the patient and can legally consent.I am under 18, have IRB approval, can agree to participate, and my parent or guardian has given permission.My acute GVHD is less severe and I'm on a stable dose of treatment.I am a woman who can have children and have a negative pregnancy test or am using contraception.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A - NK-DLI + DUK-CPG-001
- Group 2: Cohort B - NK-DLI + DUK-CPG-001
- Group 3: Cohort B - NK cell enriched-DLI only
- Group 4: Cohort A - NK cell enriched-DLI only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the desired outcome of this medical research?
"The primary aim of this 100-day trial is to determine Progression Free Survival rate. The secondary objectives include assessing immune function before and after infusion, as measured by Elispot assay or Flow-cytometric cytokine assay, in patients receiving NK cell-enriched DLI administered alone or with TLR9 ligand DUK-CPG001; additionally, tracking the recovery of immune cell populations pre and post infusion will be conducted."
Answered by AI
Is the enrollment period for this clinical trial still open?
"Per information found on clinicaltrials.gov, enrollment for this medical trial is currently in progress. This experiment was initially posted on June 8th 2016 and the last modification occurred March 8th 2022."
Answered by AI
How many participants have enrolled in this research endeavor?
"Affirmative. The information found on clinicaltrials.gov reveals that this trial is presently in search of participants, which was initially posted on June 8th 2016 and most recently updated on March 8th 2022. 100 volunteers are wanted from 1 medical site."
Answered by AI
Has the combination of NK-DLI and DUK-CPG-001 been authorized by the FDA?
"While clinical data is limited, NK-DLI + DUK-CPG-001 received a safety score of 2 due to the Phase 2 trial status. This indicates that some evidence exists regarding its overall security but no proof has been established in regards to its efficacy."
Answered by AI
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