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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post transplant

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%

Hypokalemia

13%

Anorexia

13%

Anemia

13%

Veno-occlusive Disease/ Hepatic Sinusoidal Obstruction Syndrome

Hypertension

Platelet Count Decreased

White Blood cells decreased

Graft Failure

Neutrophil Count Decreased

Cystitis

Broviac Cather Infection

Intracranial Hemorrhage

Acute GVHD

100%

80%

60%

40%

20%

Study treatment Arm

Haploidentical BMT With PTCy for Acute Leukemias and MDS

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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