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Monoclonal Antibodies

Transplant Conditioning Regimen for Blood Disorders

Phase 1 & 2

Recruiting

Led By Shalini Shenoy, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

If sickle cell, Hemoglobin S must be less than 30%

Stratum 1: Patient must have a non-malignant disorder, excluding thalassemia, and must be receiving a 8/8 HLA-matched bone marrow, related or unrelated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years post-transplant

Awards & highlights

Study Summary

This trial is testing a new way to prepare for a bone marrow transplant that may be less intense and have fewer side effects.

Who is the study for?

This trial is for children and young adults under 21 with non-cancerous blood, bone marrow, or metabolic disorders. They must have a matched donor for bone marrow or umbilical cord blood transplant and be in good health otherwise. Pregnant individuals, those with HIV, or active infections cannot participate.Check my eligibility

What is being tested?

The study tests a new transplant conditioning regimen that uses Campath (an immunosuppressive drug), Fludarabine (a chemotherapy agent), and Melphalan (another chemotherapy) to prepare patients' bodies to accept donor cells without fully destroying their own bone marrow.See study design

What are the potential side effects?

Potential side effects may include immune system suppression leading to increased infection risk, reactions related to the infusion of drugs, organ inflammation due to strong medications used in the treatment plan, and general symptoms like fatigue.

Eligibility Criteria

Inclusion Criteria

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

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My Hemoglobin S level is below 30%.

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I have a non-cancerous condition and am getting a fully matched bone marrow transplant.

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I have thalassemia and am getting a closely matched bone marrow or cord blood transplant.

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I have a non-cancerous condition and am getting a closely matched bone marrow or cord blood transplant.

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I am under 21 years old.

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I can carry out daily activities with some help or on my own.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years post-transplant

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

Treatment Details

Study Objectives

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

Primary outcome measures

Donor engraftment as measured by chimerism

Major toxicities as graded by the CTC v4

Secondary outcome measures

Immune reconstitution by laboratory evaluations

Incidence of acute graft-versus-host disease as measured by protocol grading scale

Graft-vs-Host Disease

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Stratum 4Experimental Treatment3 Interventions

Recipient with non-malignant disorder, excluding hemoglobinopathy Related or unrelated. 7/8 HLA-matched bone marrow or 5-8/8 HLA-matched UCB

Group II: Stratum 3Experimental Treatment3 Interventions

Recipient with hemoglobinopathy Related or unrelated. 7/8 HLA-matched bone marrow or 5-8/8 HLA-matched UCB

Group III: Stratum 2Experimental Treatment3 Interventions

Recipient with transfusion dependent thalassemia. Related or unrelated. 8/8 HLA-matched bone marrow or 5-8/8 HLA-matched UCB

Group IV: Stratum 1Experimental Treatment2 Interventions

Recipients with non-malignant disorders, excluding thalassemia. Related or unrelated 8/8 HLA-matched bone marrow

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,587 Total Patients Enrolled

St. Louis Children's HospitalOTHER

29 Previous Clinical Trials

93,326 Total Patients Enrolled

Shalini Shenoy, MDPrincipal InvestigatorWashington University School of Medicine (in St. Louis)

2 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

Campath (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00920972 — Phase 1 & 2

Non-Malignant Disorders Research Study Groups: Stratum 1, Stratum 2, Stratum 3, Stratum 4

Non-Malignant Disorders Clinical Trial 2023: Campath Highlights & Side Effects. Trial Name: NCT00920972 — Phase 1 & 2

Campath (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00920972 — Phase 1 & 2

Frequently Asked Questions

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

Is this study still open to new participants?

"That is correct, the online information indicates that this research is looking for more subjects. This trial was first advertised on December 1st 2001 and updated October 12th 2021. The aim is to have 220 people enrolled at 20 different hospitals or clinics."

Answered by AI

What is the projected class size for this trial?

"That is accurate. The latest information on clinicaltrials.gov reveals that this trial, which was first announced on December 1st 2001, is still looking for participants. They need to enroll 220 patients from 20 different locations."

Answered by AI

What is the purpose of this clinical trial?

"The purpose of this 100-day clinical trial is to evaluate the major toxicities of a new transplant treatment. Secondary outcomes include immune reconstitution, T cell function, B cell function, and incidence of acute graft-versus-host disease. Finally, the time to neutrophil and platelet engraftment will be measured."

Answered by AI

Is this trial being held in more than one state?

"In addition to All Children's Hospital in Saint Petersburg, Florida, Louisiana State University in New Orleans, Louisiana, and St. Louis University in Saint Louis, Oklahoma, this clinical trial is also enrolling patients at 20 other locations."

Answered by AI

Recent research and studies

Bone Marrow TransplantationJournal

Reduced-intensity Conditioning Is Effective and Safe for Transplantation of Patients with Shwachman–diamond Syndrome

Bhatla, D, S M Davies, S Shenoy, R E Harris, M Crockett, L Shoultz, T Smolarek, et al.. 2008. “Reduced-intensity Conditioning Is Effective and Safe for Transplantation of Patients with Shwachman–diamond Syndrome”. Bone Marrow Transplantation. Springer Science and Business Media LLC. doi:10.1038/bmt.2008.151.

Bone Marrow TransplantationJournal

Allogeneic Hematopoietic Cell Transplantation (HCT) in Hurler's Syndrome Using a Reduced Intensity Preparative Regimen

Hansen, M D, A H Filipovich, S M Davies, P Mehta, J Bleesing, S Jodele, R Hayashi, Y Barnes, and S Shenoy. 2007. “Allogeneic Hematopoietic Cell Transplantation (HCT) in Hurler's Syndrome Using a Reduced Intensity Preparative Regimen”. Bone Marrow Transplantation. Springer Science and Business Media LLC. doi:10.1038/sj.bmt.1705926.

Bone Marrow TransplantationJournal

A Novel Reduced-intensity Stem Cell Transplant Regimen for Nonmalignant Disorders

Shenoy, S, W J Grossman, J DiPersio, L C Yu, D Wilson, Y J Barnes, T Mohanakumar, A Rao, and R J Hayashi. 2004. “A Novel Reduced-intensity Stem Cell Transplant Regimen for Nonmalignant Disorders”. Bone Marrow Transplantation. Springer Science and Business Media LLC. doi:10.1038/sj.bmt.1704795.

BloodJournal