← Back to Search

Stem Cell Transplant + Chemotherapy for Leukemia and Lymphoma

Phase 1 & 2
Waitlist Available
Led By Christine Ho
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a Karnofsky performance status score of > 50%
Left ventricular ejection fraction > 40%
Must not have
Known human immunodeficiency virus (HIV) positive
Pregnant or nursing female participants
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Summary

This trial is studying how well chemotherapy, total body irradiation, and post-transplant cyclophosphamide work in reducing rates of graft versus host disease in patients with hematologic malignancies undergoing a donor stem cell transplant.

Who is the study for?
This trial is for patients with various blood cancers or bone marrow disorders who have a compatible donor for stem cell transplant. They should be in certain disease states, like remission or very good partial response, and have adequate organ function. Participants must not be HIV positive, pregnant, nursing, or have severe myelofibrosis; they need to understand the study and agree to use birth control.
What is being tested?
The trial tests if chemotherapy combined with total body irradiation and post-transplant cyclophosphamide can reduce graft versus host disease after a donor stem cell transplant. It includes drugs like fludarabine phosphate and melphalan hydrochloride that stop cancer cells from growing.
What are the potential side effects?
Potential side effects include damage to organs due to chemotherapy and radiation, increased risk of infections from immune suppression, possible infertility due to treatment regimens, fatigue from anemia caused by bone marrow suppression, nausea/vomiting from chemo drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am able to care for myself but cannot do normal activities or work.
Select...
My heart pumps well, with an ejection fraction over 40%.
Select...
I am approved to undergo a specific radiation dose before a transplant.
Select...
My lymphoma is currently in complete remission.
Select...
My bone marrow has less than 5% myeloblasts.
Select...
I have a donor match for my transplant.
Select...
I have severe aplastic anemia and if I have a mismatched donor, I've been treated with ATG.
Select...
I have been diagnosed with a specific type of blood cancer or severe aplastic anemia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am HIV positive.
Select...
I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Extensive chronic graft versus host disease (GVHD)
Secondary study objectives
Clinical response assessed as per bone marrow transplant (BMT) standard of care
Cumulative incidence of grade III-IV acute graft versus host disease (GVHD)
Cumulative incidence of relapse
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (chemotherapy, TBI, cyclophosphamide)Experimental Treatment8 Interventions
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
2013
Completed Phase 4
~2750
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1240
Cyclophosphamide
2010
Completed Phase 4
~2320
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Total-Body Irradiation
1997
Completed Phase 3
~1180
Melphalan Hydrochloride
2016
Completed Phase 2
~130
Fludarabine Phosphate
1997
Completed Phase 3
~2390

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
408 Previous Clinical Trials
32,383 Total Patients Enrolled
Christine HoPrincipal InvestigatorRoswell Park Cancer Institute
Maureen RossPrincipal InvestigatorRoswell Park Cancer Institute

Media Library

Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial Eligibility Overview. Trial Name: NCT03192397 — Phase 1 & 2
Graft-versus-Host Disease Research Study Groups: Prevention (chemotherapy, TBI, cyclophosphamide)
Graft-versus-Host Disease Clinical Trial 2023: Allogeneic Hematopoietic Stem Cell Transplantation Highlights & Side Effects. Trial Name: NCT03192397 — Phase 1 & 2
Allogeneic Hematopoietic Stem Cell Transplantation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03192397 — Phase 1 & 2
~4 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top