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Stem Cell Transplant + Immunotherapy for Blood Cancers

Q: How is CD19+ commonly employed therapeutically?

<p>Certain forms of <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>, leukemia, and <a href="https://www.withpower.com/clinical-trials/acute-lymphoblastic-leukemia">acute lymphoblastic leukemia</a> (including myelocytic and refractory B-cell precursor varieties) can be addressed with CD19+ treatment.</p>

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.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum effective dose for prophylactic CD45RA-depleted DLI

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

Secondary outcome measures

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

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

Blinatumomab

FDA approved

Filgrastim

FDA approved

Coenzyme M

FDA approved

Fludarabine

FDA approved

Cyclophosphamide

FDA approved

0 / 20Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

428 Previous Clinical Trials

5,306,473 Total Patients Enrolled

Brandon Triplett, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

7 Previous Clinical Trials

1,235 Total Patients Enrolled

Media Library

Cyclophosphamide (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03849651 — Phase 2

Acute Lymphoblastic Leukemia Research Study Groups: Transplant participants

Acute Lymphoblastic Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03849651 — Phase 2

Cyclophosphamide (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03849651 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks have been associated with CD19+ for those undergoing treatment?

"Although CD19+ has yet to demonstrate efficacy, there is enough evidence of safety for us at Power to rate it a 2 on the scale from 1 to 3."

Answered by AI

How is CD19+ commonly employed therapeutically?

"Certain forms of multiple sclerosis, leukemia, and acute lymphoblastic leukemia (including myelocytic and refractory B-cell precursor varieties) can be addressed with CD19+ treatment."

Answered by AI

What can we anticipate from the outcomes of this research?

"This study will be evaluated for 90 days after the last participant's transplant date. The primary outcome is One-Year Event Free Survival (EFS) post protocol completion, while secondary objectives include: estimating cumulative incidences of acute and chronic GVHD via Kalbfleisch-Prentice method with death as competing risk; assessing severity of both acute and chronic GVHD; calculating cumulative incidence of transplant related mortality through Kalbfleisch-Prentice methodology where pre 100 day deaths from other causes are considered a competing event; estimating relapse rate using Kalbfleisch-Prentice modeling again considering death as competing risk factor; computing Kaplan"

Answered by AI

How many individuals have been accepted into this trial thus far?

"Affirmative. Clinicaltrials.gov reveals that this research trial, which was initially shared on January 31st 2019 is actively recruiting patients. 140 participants need to be sourced from 1 medical centre for the study's completion."

Answered by AI

What other explorations have focused on the CD19+ population?

"At this moment in time, 1066 trials pertaining to CD19+ are ongoing - with 192 at the Phase 3 stage. While many of these tests occur within Philadelphia, Pennsylvania, there exist 32111 locations running clinical experiments for CD19+."

Answered by AI

Is enrollment for this clinical trial still available to participants?

"Affirmative, the details available on clinicaltrials.gov demonstrate that this medical trial is presently enrolling participants. It was initially published on January 31st 2019 and most recently updated on October 3rd 2022. The study requires 140 individuals to be recruited from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies

2019. "TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03849651.

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