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Stem Cell Transplant for Blood Cancers

Phase 2

Recruiting

Led By Usama Gergis, MD

Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria Checklist

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

Must have

Patients must have adequate organ function including cardiac, pulmonary, liver, renal, and performance status criteria

Patients with untreated hematologic malignancies where allogeneic HSCT is the sole or best option for cure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing how well a donor's stem cells can treat patients with high-risk blood cancers.

Who is the study for?

This trial is for adults with high-risk blood cancers who have a partially matched related donor. They must be in good health with proper heart, lung, liver function, and kidney clearance. A performance status showing they're mostly independent in daily activities is required. HIV-positive individuals, those with central nervous system cancer involvement or significant psychiatric disorders are excluded.Check my eligibility

What is being tested?

The study tests if a stem cell transplant from a donor after receiving full-body radiation and chemotherapy can treat patients with aggressive blood cancers effectively without causing severe side effects. The goal is to stop cancer growth and prevent the immune system from rejecting the new cells.See study design

What are the potential side effects?

Potential side effects include reactions to the infusion of stem cells, damage to organs due to radiation and chemotherapy (like heart or lung problems), increased risk of infections because of weakened immunity, and possible graft-versus-host disease where donated cells attack the body.

Eligibility Criteria

Inclusion Criteria

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

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My heart, lungs, liver, kidneys, and overall health are in good condition.

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I have a blood cancer and a stem cell transplant is my best chance for a cure.

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I have a donor who is partially matched to me for a transplant.

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I am 18 years old or older.

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I am undergoing a stem cell transplant for my blood cancer, hoping for a cure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at two years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overall Survival (OS)

Secondary outcome measures

Incidence of graft failure

Perinatal death

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (TBI, DLI, chemotherapy, HSCT)Experimental Treatment6 Interventions

Patients undergo Total-Body Irradiation (TBI) twice daily on days -10 to -8 and and donor lymphocyte infusion (DLI) on day -6. Patients receive cyclophosphamide IV on days -3 and -2, tacrolimus IV beginning on day -1 and then orally at least 2 or 3 days prior to discharge with taper starting on day 42, and mycophenolate mofetil IV twice daily on days -1 to 28. Patients undergo Allogeneic Hematopoietic Stem Cell Transplantation on day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mycophenolate mofetil

FDA approved

Cyclophosphamide

FDA approved

Donor Lymphocyte Infusion

1995

Completed Phase 2

~50

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1200

Tacrolimus

FDA approved

Total-Body Irradiation

1997

Completed Phase 3

~1180

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor

162 Previous Clinical Trials

10,848 Total Patients Enrolled

Usama Gergis, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

3 Previous Clinical Trials

84 Total Patients Enrolled

Dolores Grosso, DNPPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University

1 Previous Clinical Trials

76 Total Patients Enrolled

Media Library

Allogeneic Hematopoietic Stem Cell Transplantation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03032783 — Phase 2

Blood Cancers Research Study Groups: Treatment (TBI, DLI, chemotherapy, HSCT)

Blood Cancers Clinical Trial 2023: Allogeneic Hematopoietic Stem Cell Transplantation Highlights & Side Effects. Trial Name: NCT03032783 — Phase 2

Allogeneic Hematopoietic Stem Cell Transplantation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03032783 — Phase 2

Frequently Asked Questions

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

Does the FDA recognize Allogeneic Hematopoietic Stem Cell Transplantation as a legitimate medical procedure?

"While Phase 2 trials don't have as much data supporting efficacy, Allogeneic Hematopoietic Stem Cell Transplantation's safety has been studied more and it received a score of 2."

Answered by AI

Are we still able to enroll volunteers for this research?

"The listing on clinicaltrials.gov says that this study is currently seeking patients. It was originally posted on 1/31/2017, and the most recent update was on 9/7/2022. 63 participants are needed for this trial taking place at a single site."

Answered by AI

Are there other ongoing clinical trials that use Allogeneic Hematopoietic Stem Cell Transplantation?

"There are currently 980 clinical trials underway for allogeneic hematopoietic stem cell transplantation, with 178 of them in Phase 3. Many of the trials are located in Philadelphia, Pennsylvania, but there are 28992 locations operating trials for allogeneic hematopoietic stem cell transplantation."

Answered by AI

What is Allogeneic Hematopoietic Stem Cell Transplantation's most popular use?

"Allogeneic Hematopoietic Stem Cell Transplantation can be used to treat a variety of conditions, such as dermatitis, atopic, multiple sclerosis, and leukemia."

Answered by AI

Could you give me a number for how many people are included in this experiment?

"From the information available on clinicaltrials.gov, it seems that this particular trial is ongoing and actively recruiting patients. The listing indicates that the study was first posted on 1/31/2017, with the most recent edit taking place on 9/7/2022. They are seeking to enroll a total of 63 participants across one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies-Increasing GVT Effects Without Increasing Toxicity

2017. "A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies-Increasing GVT Effects Without Increasing Toxicity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03032783.

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