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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 belowSelect...
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 weeks3 visits
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
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
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need a stem cell transplant for my high-risk cancer but don't have a matching donor.My cancer is in remission and is one of the specified high-risk types.I have a family member who can donate bone marrow to me.I don't have a perfectly matched donor or need a transplant very soon.My lung function is significantly reduced.My acute leukemia is not responding to treatment or is getting worse.I do not have an active infection at the time of my bone marrow transplant.My HLA typing shows a minimum 5/10 match with my donor.My heart's pumping ability is significantly reduced.My lymphoma has not responded to treatment.My leukemia has spread to my brain and hasn't been treated or is getting worse.I have had a fungal infection within 3 months after my bone marrow transplant.My kidney function is not normal.I need assistance with daily activities due to my health condition.I have health conditions that make bone marrow transplant too risky for me.
Research Study Groups:
This trial has the following groups:- Group 1: Cyclophosphamide and Bendamustine
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.
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