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Alkylating agents

BMT with Bendamustine + Cyclophosphamide for Leukemia

Phase 1
Waitlist Available
Led By Emmanuel Katsanis, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with high-risk malignancies requiring hematopoietic cell transplantation (HCT) without an available HLA-matched donor or acceptable cord blood
Specific high-risk malignancies include ALL, AML, undifferentiated acute leukemia, MDS, CML, and various types of lymphoma in remission
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 3 years. interim analysis will be performed after cohort 3 and cohort 6 in phase 1, and include preliminary evaluation of treatment and control groups
Awards & highlights

Study Summary

This trial is evaluating the safety of replacing part of the standard immunosuppressive treatment given to haploidentical hematopoietic cell transplantation patients with bendamustine.

Who is the study for?
This trial is for patients with high-risk blood cancers like ALL, AML, CML, MDS, and various lymphomas who need a bone marrow transplant but don't have a fully matched donor. They must have at least one half-matched (haploidentical) related donor available and be able to consent to the study. People can't join if they have untreated brain leukemia, severe heart or liver problems, active infections or certain other health issues.Check my eligibility
What is being tested?
The trial tests replacing some doses of post-transplant cyclophosphamide (a standard drug given after bone marrow transplants) with bendamustine to see if it's safe and works well in haploidentical bone marrow transplantation for blood cancer patients.See study design
What are the potential side effects?
Possible side effects include reactions from the infusion of drugs such as fever or chills; damage to organs like the heart or liver; increased risk of infections; fatigue; nausea; low blood counts leading to bleeding or anemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need a stem cell transplant for my high-risk cancer but don't have a matching donor.
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My cancer is in remission and is one of the specified high-risk types.
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I have a family member who can donate bone marrow to me.
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My HLA typing shows a minimum 5/10 match with my donor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 3 years. interim analysis will be performed after cohort 3 and cohort 6 in phase 1, and include preliminary evaluation of treatment and control groups
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 3 years. interim analysis will be performed after cohort 3 and cohort 6 in phase 1, and include preliminary evaluation of treatment and control groups for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bone Marrow Transplantation
Secondary outcome measures
Extent of chronic GvHD
Bone Marrow Transplantation
Incidence of acute GvHD
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cyclophosphamide and BendamustineExperimental Treatment2 Interventions
Experimental: Cyclophosphamide and Bendamustine Control: Cyclophosphamide Interventions: Drug: Bendamustine Drug: Cyclophosphamide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bendamustine
2015
Completed Phase 3
~2950
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
511 Previous Clinical Trials
148,238 Total Patients Enrolled
Emmanuel Katsanis, MDPrincipal InvestigatorThe University of Arizona Cancer Center

Media Library

Bendamustine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02996773 — Phase 1
Myelodysplastic Syndrome Research Study Groups: Cyclophosphamide and Bendamustine
Myelodysplastic Syndrome Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT02996773 — Phase 1
Bendamustine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02996773 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
~8 spots leftby Aug 2025