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Cell Therapy
Adoptive Immunotherapy for Leukemia
Phase 2
Waitlist Available
Led By Koen van Besien, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be 18 years of age or older
Patients with a confirmed diagnosis of AML or MDS, according to World Health Organization (WHO) classification (excluding acute promyelocytic leukaemia) with recurrent or refractory disease as defined below.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will test the safety of adoptive immunotherapy with either UCB or haplo-identical stem cells in patients with AML/MDS.
Who is the study for?
This trial is for adults with high-risk Acute Myeloid Leukemia or Myelodysplastic Syndrome who have not responded to previous chemotherapy. Participants must be over 18, have a good performance status (able to carry out daily activities), and women must test negative for pregnancy. People with HIV, recent heart issues, uncontrolled illnesses, or severe liver/kidney problems cannot join.Check my eligibility
What is being tested?
The study is testing the safety of adoptive immunotherapy using donor cells after chemotherapy in AML/MDS patients. It compares two types: cells from umbilical cord blood versus cells from a relative (haplo-identical). Each group will be analyzed separately to see which might improve remission rates and survival better.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune response such as fever or chills, risk of infection due to weakened immunity post-transplantation, graft-versus-host disease where donor cells attack the patient's body, and typical chemotherapy-related side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have AML or MDS (not acute promyelocytic leukemia) that has come back or is not responding to treatment.
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My cancer did not respond to the first 2 or more chemotherapy treatments.
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My condition has worsened for the first time since treatment.
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My cancer did not respond to the second round of chemotherapy.
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My condition has worsened or returned after treatment at least twice.
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I have MDS and my previous treatment with specific drugs didn't work.
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I am mostly able to care for myself and carry out normal activities.
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I understand the study requirements and am willing to consent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of Cellular Immunotherapy as Measured by the Number of Participants Who Developed of Cytokine Release Syndrome (CRS) or Graft-versus-host Disease (GVHD) After Adoptive Immunotherapy
Secondary outcome measures
Number of Participants That Underwent a Transplant After Response to Adoptive Immunotherapy
Number of Participants Who Developed GVHD by Severity
Number of Participants Who Responded to Treatment
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: HaploidenticalExperimental Treatment1 Intervention
Haploidentical healthy related donor (i.e. parent, child, sibling, possibly third degree or farther removed relative like cousin, aunt, nephew etc.).
Collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of treatment.
Group II: Cord Blood UnitExperimental Treatment1 Intervention
The CBU unit must supply a minimum of 0.5 x 10^7/kg and a maximum of 2.5 x 10^7/kg nucleated cell dose pre-cryopreservation. The unit must match at a minimum of 4 of 6 at HLA-A, -B antigens, -DRB1 alleles with the recipient. Mismatches (0-2) can be at any loci. Although molecular level typing will be available for the patient and the CBU unit, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1. The CBU donor will have also undergone HLA typing of the mother, thus allowing determination of the CBU-IPA and NIMA.
CBU grafts in this study will be investigational units that meet all criteria for clinical use. Better matching units will be preferred over less matching units as long as the CBU dose exceeds 0.5 x 10^7 nucleated blood cells/kg.
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,252 Total Patients Enrolled
New York Blood CenterOTHER
23 Previous Clinical Trials
26,651 Total Patients Enrolled
Koen van Besien, MDPrincipal InvestigatorWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that the doctor believes could make it too risky for you to participate in the study.My condition has worsened for the first time since treatment.My condition has worsened or returned after treatment at least twice.I do not have active heart issues like recent heart attacks or uncontrolled heart failure.I have MDS and my previous treatment with specific drugs didn't work.I am 18 years old or older.I do not have any uncontrolled illnesses or social situations that would stop me from following the study's requirements.I am mostly able to care for myself and carry out normal activities.My liver or kidney problems are severe enough to make this study too risky for me.I have AML or MDS (not acute promyelocytic leukemia) that has come back or is not responding to treatment.My cancer did not respond to the second round of chemotherapy.I still have serious side effects from past chemotherapy.My condition is acute myeloid leukemia (AML).My cancer did not respond to the first 2 or more chemotherapy treatments.I am HIV positive.I understand the study requirements and am willing to consent.
Research Study Groups:
This trial has the following groups:- Group 1: Cord Blood Unit
- Group 2: Haploidentical
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.
Are there any vacancies for participants in this trial?
"That is correct, the clinicaltrial.gov website does show that this study is looking for volunteers at the moment. The posting went up on September 10th, 2015 and was last updated February 1st, 2022. They are hoping to have 90 people total from one location."
Answered by AI
How many applicants will be accepted into this clinical research program?
"That is correct. The listing on clinicaltrials.gov notes that this study began recruitment on September 10th, 2015 and was most recently updated February 1st, 2022. There is presently a need for 90 more participants at a single enrolment site."
Answered by AI
Are there any risks associated with this medication?
"Although there is some evidence supporting the safety of this treatment, it falls into Phase 2 of clinical trials. This means that there is no solid data demonstrating its efficacy."
Answered by AI
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