← Back to Search

Anti-metabolites

Fludarabine for Sickle Cell Disease

Phase 1 & 2
Waitlist Available
Led By Molly Gallogly, MD, PhD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
a. Hemoglobin SS
b. Hemoglobin SC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help people with sickle cell disease before they have a blood stem cell transplant. The goal is to see if the drug can reduce the patient's cells from rejecting donor cells after the transplant.

Eligible Conditions
  • Sickle Cell Disease
  • Sickle Cell Anemia

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Probability of Engraftment
Secondary outcome measures
Cerebral Vasculopathy
Disease Progression
Erythropoiesis
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Immunomodulation with Fludarabine prior to HSCTExperimental Treatment2 Interventions
Fludarabine given beginning at 25mgm/m2 three times per day. Patients may be escalated up to 25mgm/m2 five times per day depending on dose-limiting toxicity
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1090
Hematopoietic Stem Cell Transplant (HSCT)
2015
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
447 Previous Clinical Trials
31,329 Total Patients Enrolled
Molly Gallogly, MD, PhDPrincipal InvestigatorCase Comprehensive Cancer Center
2 Previous Clinical Trials
26 Total Patients Enrolled
Kirsten Boughan, DOPrincipal InvestigatorCase Comprehensive Cancer Center

Frequently Asked Questions

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

How many participants are being taken into this clinical investigation?

"Yes, records from clinicaltrials.gov indicate that this trial is actively seeking volunteers. It was first published on October 19th 2015 and most recently updated on May 27th 2022, with the aim of enrolling 25 participants at 1 centre."

Answered by AI

Are there other researches conducted using Fludarabine?

"Presently, 369 clinical trials are ongoing related to Fludarabine with 22 of them in the advanced stages. Most studies occur in Boston, MA but there are 3,764 medical centres running experiments for this drug around the world."

Answered by AI

What criteria must be met for someone to participate in this research?

"The trial is open to 25 participants that have been diagnosed with sickle cell anemia and are between 18 and 65 years of age. To be eligible for the study, patients must meet any one of four criteria: iii. Chronic transfusion therapy or over 35 years old or male gender; e. 2-year mortality higher than 10-15%; c. Hemoglobin S-Beta-zero Thalassemia; d. Hemoglobin S-Beta plus Thalassemia along with a recent episode of multi organ failure within 5 years from their eligibility assessment date."

Answered by AI

Are there any slots left for participants in this research effort?

"According to clinicaltrials.gov, the enrolment period for this medical investigation is still open. It was first advertised on October 19th 2015 and underwent its last update in May 27th 2022."

Answered by AI

Are individuals aged thirty or above eligible to participate in the trial?

"This trial is open to patients aged 18 to 65. However, if the patient's age falls outside this range they may be eligible for one of 279 trials aimed at those below 18 or 370 studies meant for people over 65."

Answered by AI
~3 spots leftby Mar 2025