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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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have a family donor who matches 3/6 to 5/6 of my HLA markers and we are compatible.
Select...
I am mostly able to care for myself.
Select...
My condition is diagnosed as Aplastic Anemia with specific blood and bone marrow findings.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Demonstrate sustained engraftment after T-cell replete HLA-mismatched haploidentical bone marrow transplantation by collecting chimerism tests monthly following transplant
Secondary outcome measures
Determine incidence of chronic GVHD at 6 months and 1 year post transplantation by assessing signs and symptoms of GVHD throughout post-transplant course
Bone Transplantation
Determine the incidence of regimen-related mortality at 100 days post transplantation by recording treatment-related adverse events
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Flu/Cy/TBIExperimental Treatment4 Interventions
Fludarabine, Cyclophosphamide, TBI followed by bone marrow transplantation. Post-transplant Cyclophosphamide will be on Days 3 & 4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Rabbit ATG
2001
Completed Phase 2
~60
Cyclophosphamide
1995
Completed Phase 3
~3780
Total Body Irradiation
2006
Completed Phase 3
~820

Find a Location

Who is running the clinical trial?

Northside Hospital, Inc.Lead Sponsor
23 Previous Clinical Trials
1,048 Total Patients Enrolled
Melhem Solh, MDPrincipal InvestigatorBlood and Marrow Transplant Group of Georgia
3 Previous Clinical Trials
83 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02828592 — Phase 2
Aplastic Anemia Research Study Groups: Flu/Cy/TBI
Aplastic Anemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT02828592 — Phase 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02828592 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any potential risks associated with Fludarabine usage?

"While Fludarabine has been tested in preliminary clinical trials, there is limited data available to confirm its efficacy. As such, our team at Power assigned it a safety score of 2."

Answered by AI

What is the current capacity for participants in this medical experiment?

"Correct. An analysis of the data on clinicaltrials.gov demonstrates that this medical experiment, initially posted September 9th 2016, is presently enrolling participants; with 20 individuals being sought from 2 separate facilities."

Answered by AI

Has Fludarabine been previously studied in other experiments?

"Presently, there are 906 active clinical studies of Fludarabine with 163 in the final phase. According to current data, most trials for this medication are conducted in Philadelphia while 28490 sites around the world have opened their doors to further research on this drug."

Answered by AI

What criteria must individuals fulfill to participate in this investigation?

"To be considered, patients must suffer from anemia and aplastic anemia; additionally, they should be between 1 year and 75 years old. Notably, only 20 people are being recruited into this trial."

Answered by AI

What are the primary applications of Fludarabine as a therapeutic agent?

"Fludarabine is often used for immunosuppression, but has also been prescribed to treat multiple sclerosis, leukemia, myelocytic and acute leukemias as well as retinoblastoma."

Answered by AI

Is this research endeavor open to adults aged 18 and above?

"This medical trial is accepting patients who are between 1 year and 75 years of age."

Answered by AI

Are there any vacant spaces left for participants in this clinical trial?

"The data on clinicaltrials.gov indicates that the recruitment process is still in progress. The trial was first released to the public domain on September 9th 2016 and revised lastly on October 19th 2022."

Answered by AI
Recent research and studies
~3 spots leftby Aug 2025