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Stem Cell Selection
Stem Cell Transplant for Leukemia
Phase 1 & 2
Recruiting
Led By Diane George, MD
Research Sponsored by Diane George
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be under 22 years of age
Must have adequate liver function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post-transplant
Awards & highlights
Study Summary
This trial will use the CliniMACS® Reagent System (Miltenyi Biotec), a CD34+ selection device to remove T-cells from a peripheral blood stem cell transplant in order to decrease the risk of acute and chronic GVHD.
Who is the study for?
This trial is for children and young adults under 22 with certain blood cancers like leukemia or lymphoma, who need a stem cell transplant but standard treatments haven't worked. They must have a matched donor, good heart, kidney, liver, and lung function. Pregnant or breastfeeding individuals and those with uncontrolled infections cannot participate.Check my eligibility
What is being tested?
The study tests if removing T-cells from the donor's stem cells using CliniMACS CD34+ Reagent System can reduce graft versus host disease after transplant in patients with malignant diseases such as various types of leukemia and lymphoma.See study design
What are the potential side effects?
Possible side effects include reactions to medications used in the procedure like Alemtuzumab or Cyclophosphamide which may cause immune suppression leading to infection risk, organ damage risks from chemotherapy drugs like Melphalan or Busulfan, and infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am younger than 22 years old.
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My liver is working well.
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My lungs work well enough for normal activities.
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My donor matches me closely in immune system markers.
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My family donor matches me at least 50% for the transplant.
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My kidneys are working well.
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I have been diagnosed with cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Graft-vs-Host Disease
Secondary outcome measures
Incidence of chronic GVHD
Incidence of infection complications including bacterial, viral, fungal and atypical mycobacterial and other infections
Incidence of primary graft failure
+6 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Reduced intensityExperimental Treatment6 Interventions
Patients will begin tacrolimus 8 days pre-transplant, and then will receive alemtuzumab on the 3rd-7th day pre-transplant; busulfan twice daily on the 5th-8th day pre-transplant; and fludarabine on the 2nd-7th day pre-transplant. Methylprednisolone will start on day -7.The stem cell infusion will be performed (with CD34 Selection using CliniMACS CD34+ Reagent System). GVHD prophylaxis will consist of tacrolimus or sirolimus. For patients with a history of hepatic toxicity and/or high-risk for veno-occlusive disease or other liver toxicity post stem cell transplant, melphalan at 70 mg/m2 will be substituted for Busulfan, followed by fludarabine on the 2nd-7th day before transplant and alemtuzumab on the 3rd-7th day before transplant.
Group II: Full intensity without TBIExperimental Treatment6 Interventions
Patients will start their pre-conditioning regimen 9 days before their scheduled transplant. Patients will receive busulfan twice daily on the 5th-8th day before transplant, and Melphalan on the 2nd-4th days before transplant and Alemtuzumab on the 1st-5th day before transplant. Subjects will then undergo with their stem cell infusion (allogeneic family member or ≥ 8/10 HLA matched adult unrelated donor peripheral blood stem cell transplantation with CD34 Selection using CliniMACS CD34+ Reagent System) and GVHD prophylaxis will consist of tacrolimus only. Tacrolimus administration will begin on the day after their transplant, and methylprednisolone will start on day -5.
Group III: Full intensity with TBIActive Control6 Interventions
Patients will start their pre-conditioning regimen on 8 days before scheduled transplant. Fractionated total body irradiation (TBI) will be administered twice daily on the 6th, 7th, and 8th before transplant. Patients will receive Thiotepa on the 4th and 5th day before transplant, Cyclophosphamide on the 2nd and 3rd day before transplant, and Alemtuzumab on the 1st-5th day(s) before transplant. Then the stem cell infusion will be performed (allogeneic family member or ≥ 8/10 HLA matched adult unrelated donor peripheral blood stem cell transplantation with CD34 Selection using CliniMACS CD34+ Reagent System). GVHD prophylaxis will consist of tacrolimus only. Tacrolimus administration will begin on the day after transplant, and methylprednisolone will start on day -5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alemtuzumab
FDA approved
Tacrolimus
FDA approved
Melphalan
FDA approved
Fludarabine
FDA approved
Busulfan
FDA approved
Methylprednisolone hemisuccinate
FDA approved
Find a Location
Who is running the clinical trial?
Diane GeorgeLead Sponsor
1 Previous Clinical Trials
37 Total Patients Enrolled
Diane George, MDPrincipal Investigator - Columbia University
North General Hospital
Columbia University College Of Physicians And Surgeons (Medical School)
Bronx Municipal Hosp Center (Residency)
1 Previous Clinical Trials
37 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am younger than 22 years old.My liver is working well.My heart is functioning well.My lungs work well enough for normal activities.I am not pregnant or breastfeeding.My donor matches me closely in immune system markers.My family donor matches me at least 50% for the transplant.My kidneys are working well.I do not have any untreated infections.I have been diagnosed with cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Full intensity with TBI
- Group 2: Full intensity without TBI
- Group 3: Reduced intensity
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 50 Other Conditions - This treatment demonstrated efficacy for 50 other conditions.
- 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.
Which maladies does Tacrolimus usually alleviate?
"leukemia can often be treated with the use of Tacrolimus. However, this medication is also useful in managing ophthalmia, sympathetic, scalp structure, and lung cancers."
Answered by AI
Are there any unfilled appointments in this trial?
"That is accurate. The clinicaltrials.gov website includes information that this study is currently looking for participants. This trial was first posted on 6/3/2013 and was last updated on 6/17/2020. They are hoping to enroll 15 patients from 1 location."
Answered by AI
Are there other ongoing research projects that use Tacrolimus?
"At the present moment, 1206 different clinical trials are investigating tacrolimus. Out of those active studies, 221 are in Phase 3. While a plurality of these studies come from Philadelphia, Pennsylvania, there is significant global interest with 33919 research sites."
Answered by AI
How many people are trying out this new medical treatment?
"That is correct. The clinicaltrials.gov website mentions that this study is enrolling patients at the moment. This research was first advertised on 6/3/2013 and had new information added as recently as 6/17/2020. They are looking to have a total of 15 people participate across 1 location."
Answered by AI
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