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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
Must not have
CML in blast crisis
Active central nervous system malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post transplant
Awards & highlights

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.
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.
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 below
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I am mostly able to care for myself and carry out daily activities.
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My blood cancer cannot be cured with standard chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition is chronic myeloid leukemia in its most advanced stage.
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I have an active brain or spinal cord tumor.
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I am HIV positive.
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I had a bone marrow transplant less than 3 months ago.
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I currently have an infection that hasn't been treated.
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My lymphoma is getting worse despite treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Probability of Acute Graft Versus Host Disease (GVHD)
Secondary study objectives
Chimerism
Incidence of Acute GVHD
Neutrophil Engraftment

Side effects data

From 2020 Phase 2 trial • 35 Patients • NCT02120157
34%
Oral Mucositis
25%
Vomiting
25%
Diarrhea
16%
Fever
16%
Hypomagnesemia
13%
Nausea
13%
Anemia
13%
Anorexia
13%
Hypokalemia
13%
Veno-occlusive Disease/ Hepatic Sinusoidal Obstruction Syndrome
9%
Platelet Count Decreased
9%
Hypertension
9%
White Blood cells decreased
9%
Graft Failure
6%
Neutrophil Count Decreased
3%
Cystitis
3%
Acute GVHD
3%
Broviac Cather Infection
3%
Intracranial Hemorrhage
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 4
~1860
Cyclophosphamide
2010
Completed Phase 4
~2320

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
278 Previous Clinical Trials
15,575 Total Patients Enrolled
72 Trials studying Leukemia
3,257 Patients Enrolled for Leukemia
Claudio Brunstein, MD, PhDPrincipal InvestigatorUniversity of Minnesota
7 Previous Clinical Trials
414 Total Patients Enrolled
4 Trials studying Leukemia
31 Patients Enrolled for Leukemia
Margaret MacMillan, MD, MSCPrincipal InvestigatorUniversity of Minnesota

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02722668 — Phase 2
Leukemia Research Study Groups: ATG, No ATG
Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT02722668 — Phase 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02722668 — Phase 2
~2 spots leftby Sep 2025
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