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Alkylating agents

Haploidentical Bone Marrow Transplant for Aplastic Anemia

Phase 2

Recruiting

Led By Melhem Solh, MD

Research Sponsored by Northside Hospital, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Availability of 3/6 - 5/6 matched (HLA-A, B, DR) related donor who must have negative HLA cross-match in the host vs. graft direction

KPS >= 70%

Must not have

Poor pulmonary function (FEV1 & FVC <50% predicted)

Poor liver function (bili >= 2mg/dL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for severe aplastic anemia, which is a rare and serious form of bone marrow failure. The new treatment is using a haploidentical donor for transplantation, which has good response rates and significantly lower rates of acute and chronic GVHD.

Who is the study for?

This trial is for people under 75 with severe aplastic anemia who haven't found a perfect bone marrow match but have a related donor partially matched. They should be in relatively good health, with their heart, lungs, liver, and kidneys functioning well.

What is being tested?

The study tests if bone marrow transplants from half-matched donors followed by Cyclophosphamide can help patients with severe aplastic anemia. It includes Fludarabine and Rabbit ATG treatment plus low-dose Total Body Irradiation.

What are the potential side effects?

Possible side effects include damage to organs like the heart or lungs due to radiation, immune reactions against the host body (GVHD), infections because of weakened immunity, bleeding issues, and effects on liver and kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a family donor who matches 3/6 to 5/6 of my HLA markers and we are compatible.

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I am mostly able to care for myself.

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My condition is diagnosed as Aplastic Anemia with specific blood and bone marrow findings.

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 liver is not functioning well (bilirubin >= 2mg/dL).

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I have had a transplant from a donor.

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My kidney function is poor, with high creatinine or low clearance.

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My heart's pumping ability is below 40%.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Demonstrate sustained engraftment after T-cell replete HLA-mismatched haploidentical bone marrow transplantation by collecting chimerism tests monthly following transplant