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Stem Cell Selection

Stem Cell Transplant for Leukemia

Phase 1 & 2

Waitlist Available

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

Must not have

Females who are pregnant or breast feeding at the time of study entry are not eligible

Patients with documented uncontrolled infection at the time of study entry are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years post-transplant

Awards & highlights

All Individual Drugs Already Approved

Approved for 50 Other Conditions

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I do not have any untreated infections.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Graft-vs-Host Disease

Secondary study objectives

Incidence of chronic GVHD

Incidence of infection complications including bacterial, viral, fungal and atypical mycobacterial and other infections

Incidence of primary graft failure

+6 more

Awards & Highlights

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.

Trial 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