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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

Must not have

Abnormal pulmonary function (DLCO < 40% of normal or O2 Sat <92%)

Refractory acute leukemia or progressive disease

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lung function is significantly reduced.

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My acute leukemia is not responding to treatment or is getting worse.

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I do not have an active infection at the time of my bone marrow transplant.

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My heart's pumping ability is significantly reduced.

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My lymphoma has not responded to treatment.

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My leukemia has spread to my brain and hasn't been treated or is getting worse.

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My kidney function is not normal.

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I need assistance with daily activities due to my health condition.

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

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.