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Stem Cell Transplant + Immunotherapy for Blood Cancers

Phase 2

Waitlist Available

Led By Brandon Triplett, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must fulfill pre-transplant organ function criteria: Left ventricular ejection fraction > 40%, or shortening fraction ≥ 25%. Creatinine clearance (CrCl) or glomerular filtration rate (GFR) ≥ 50 ml/min/1.73m2. Forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing. Karnofsky or Lansky (age-dependent) performance score ≥ 50 (See APPENDIX A). Bilirubin ≤ 3 times the upper limit of normal for age. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age. Not pregnant. If female with child bearing potential, must be confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment. Not breast feeding. Does not have current uncontrolled bacterial, fungal, or viral infection.

Age less than or equal to 21 years.

Must not have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days after the transplant date of the last enrolled patient.

Awards & highlights

All Individual Drugs Already Approved

Approved for 20 Other Conditions

No Placebo-Only Group

Summary

This trial is for patients aged 21 and under with a high-risk hematologic cancer who are in remission but are at high risk of relapse. If they have a suitable donor, they will be given chemotherapy and a donor blood cell infusion. The trial is testing the safety and effects of the chemotherapy and the donor blood cell infusions on the transplant recipient's disease and overall survival.

Who is the study for?

This trial is for children and young adults up to 21 years old with high-risk blood cancers like leukemia or lymphoma, who are in remission but at risk of relapse. They must have a partially matched family donor available quickly, be HIV negative, not pregnant or breastfeeding, and their major organs must function well. It's not open to those with other active cancers or who've had certain transplants within the last year.

What is being tested?

The study tests a transplant using blood cells from a family member that have been modified in the lab to reduce graft-vs-host disease risk. These cells lack TCRαβ proteins known for causing this complication. After engraftment, patients receive an additional infusion of memory T-cells from the donor. The effects on patient survival and cancer recurrence are being studied alongside chemotherapy drugs used.

What are the potential side effects?

Potential side effects include reactions related to immune system suppression such as increased infection risk due to chemotherapy and complications from graft-vs-host disease prevention measures. Specific side effects will depend on individual responses to treatment components like Thiotepa, Melphalan, Blinatumomab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or younger.

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My chronic myeloid leukemia is in an advanced stage or not responding well to current treatment.

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My blood cancer is considered high risk, with specific genetic features or poor response to initial treatment.

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I am 18 years old or older.

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I have been approved as a donor according to the required regulations.

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My previous brain leukemia is treated and currently in remission.

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My Hodgkin lymphoma is in its second or later remission after a failed stem cell transplant, or I can't undergo such a transplant due to cell mobilization issues.

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I have a family member who is at least a half match for organ or tissue donation.

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My AML is considered high risk based on specific genetic features.

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My acute myeloid leukemia is in its second or later remission.

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I haven't had a bone marrow transplant from a donor or myself in the last year.

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My non-Hodgkin lymphoma is in its second or later remission after a failed stem cell transplant, or I can't undergo such a transplant due to cell mobilization issues.

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I have a family member who is a partial match for a donation.

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I have no active cancer other than the one I'm seeking treatment for.

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My leukemia is in the first or later remission.

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I have been diagnosed with JMML.

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I don't have a matching family or unrelated donor for cell donation in time.

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My acute lymphoblastic leukemia is in its third or later remission.

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My condition is either primary or secondary MDS.

Exclusion Criteria

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

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N/A

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days after the transplant date of the last enrolled patient.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days after the transplant date of the last enrolled patient.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days after the transplant date of the last enrolled patient. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum effective dose for prophylactic CD45RA-depleted DLI

One-year Event Free Survival (EFS) after completion of the protocol

Secondary study objectives

The cumulative incidence of acute and chronic Graft-Versus-Host Disease (GVHD)

The cumulative incidence of transplant related mortality

The estimate of cumulative incidence of relapse

+1 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 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transplant participantsExperimental Treatment12 Interventions

Participants receive a conditioning regimen of ATG (rabbit),Cyclophosphamide 60 mg/kg intravenous once daily, mesna, fludarabine, thiotepa, melphalan, followed by HPC,A Infusion(TCRα/β+ and CD19+ depleted),HPC, A infusion (if needed to achieve goal CD34+ cell dose.CD45RA-depleted DLI will be given at least two weeks after engraftment. Blinatumomab will be given at least one week post-DLI, and only to patients with CD19+ malignancies. G-csf 5mcg/kg subcutaneous or intravenous daily until ANC \>2000 for 2 consecutive days. Cells for infusion are prepared using the CliniMACS system.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CliniMACS

2005

Completed Phase 3

~770

Thiotepa

FDA approved

Melphalan

FDA approved