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Alkylating agents
UCB Transplant After Non-Myeloablative Prep for Blood Cancers
Phase 2
Waitlist Available
Led By Claudio Brunstein, MD, PhD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (< 16 years)
Eligible Diseases: Advanced hematologic malignancies not curable by conventional chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post transplant
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that uses a less intense form of chemotherapy followed by a bone marrow transplant. The new treatment is based on the patient's diagnosis, disease status, and prior treatment.
Who is the study for?
This trial is for people under 75 with certain blood cancers or bone marrow diseases who don't have a fully matched sibling donor. They must be in good enough health, agree to birth control if they can have children, and give written consent. It's not for pregnant women, those breastfeeding, or patients with specific progressing lymphomas or recent transplants.Check my eligibility
What is being tested?
The study tests a non-myeloablative transplant prep using drugs like cyclophosphamide and fludarabine along with total body irradiation (TBI). Patients will receive umbilical cord blood cells selected by the University of Minnesota's guidelines. The aim is to treat advanced hematologic malignancies.See study design
What are the potential side effects?
Possible side effects include reactions to medications like MMF and sirolimus, low blood counts from chemotherapy agents ATG, Fludarabine, Cyclophosphamide; organ damage due to TBI; and complications from the umbilical cord blood cell infusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly able to care for myself and carry out daily activities.
Select...
My blood cancer cannot be cured with standard chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Probability of Acute Graft Versus Host Disease (GVHD)
Secondary outcome measures
Chimerism
Incidence of Acute GVHD
Neutrophil Engraftment
+1 moreSide effects data
From 2020 Phase 2 trial • 35 Patients • NCT0212015734%
Oral Mucositis
25%
Vomiting
25%
Diarrhea
16%
Hypomagnesemia
16%
Fever
13%
Anorexia
13%
Hypokalemia
13%
Nausea
13%
Veno-occlusive Disease/ Hepatic Sinusoidal Obstruction Syndrome
13%
Anemia
9%
Hypertension
9%
Graft Failure
9%
Platelet Count Decreased
9%
White Blood cells decreased
6%
Neutrophil Count Decreased
3%
Acute GVHD
3%
Broviac Cather Infection
3%
Intracranial Hemorrhage
3%
Cystitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Haploidentical BMT With PTCy for Acute Leukemias and MDS
Trial Design
2Treatment groups
Experimental Treatment
Group I: No ATGExperimental Treatment6 Interventions
Hematologic malignancy patients who have received a previous autologous transplant or ≥ 2 cycles of multi-agent chemotherapy within the 3 months previous to umbilical cord blood transplantation.
Group II: ATGExperimental Treatment7 Interventions
Hematologic malignancy patients who have not been treated with prior autologous transplant or ≤ 1 cycle of chemotherapy in the 3 months previous to umbilical cord blood transplantation, should receive Anti-thymocyte Globulin (ATG) as part of their conditioning regimen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
2013
Completed Phase 4
~2750
MMF
2012
Completed Phase 4
~1580
TBI
2014
Completed Phase 2
~1040
ATG
2016
Completed Phase 4
~1070
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3780
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,609 Total Patients Enrolled
Claudio Brunstein, MD, PhDPrincipal InvestigatorUniversity of Minnesota
7 Previous Clinical Trials
414 Total Patients Enrolled
Margaret MacMillan, MD, MSCPrincipal InvestigatorUniversity of Minnesota
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am physically active and can care for myself.My condition is chronic myeloid leukemia in its most advanced stage.Your tests show that your disease is getting worse.I am under 70 without a matching sibling donor or between 70 and 75 with low health issues.My lymphoma is considered bulky.My heart, lungs, liver, and kidneys are all working well.I agree to use birth control during the study.I have an active brain or spinal cord tumor.I am mostly able to care for myself and carry out daily activities.I am HIV positive.My umbilical cord blood graft was chosen using a specific selection method.My blood cancer cannot be cured with standard chemotherapy.I had a bone marrow transplant less than 3 months ago.I currently have an infection that hasn't been treated.My lymphoma is getting worse despite treatment.I have a specific type of blood cancer such as leukemia, lymphoma, or myeloma.
Research Study Groups:
This trial has the following groups:- Group 1: ATG
- Group 2: No ATG
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions are typically treated with traumatic brain injury therapy?
"TBI has traditionally been used to aid in organ transplantation, but it can also be a potent therapeutic for multiple sclerosis, leukemia, myelocytic disease, acute rejection and kidney transplants."
Answered by AI
Have any other investigations been conducted involving Traumatic Brain Injury?
"Presently, 1031 trials with regards to traumatic brain injury (TBI) are in progress. Out of those studies, 184 have reached Phase 3 development. The majority of these TBI trails can be found in Philadelphia, Pennsylvania; however they span across 29894 medical facilities worldwide."
Answered by AI
How many individuals can partake in this clinical inquiry?
"Affirmative. According to records on clinicaltrials.gov, this medical trial began recruitment on May 15th 2017 and is actively searching for 162 participants at 1 sites. The information was last revised in November 18th 2022."
Answered by AI
Has the Food and Drug Administration sanctioned TBI for clinical use?
"Our experts at Power have judged that TBI is moderately safe, granting it a score of 2. This evaluation takes into consideration its Phase 2 status, which implies some safety data but no evidence for efficacy yet."
Answered by AI
Is there an ongoing recruitment process for this clinical experiment?
"Affirmative. Clinicaltrials.gov's records suggest that this research is currently enrolling participants, with 162 patients being recruited from a single medical facility since the clinical trial was first posted on May 15th 2017 and last updated November 18th 2022."
Answered by AI
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