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Monoclonal Antibodies
Hu8F4 for Blood Cancers
Phase 1
Waitlist Available
Led By Tapan M Kadia
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial looks at the side effects and best dose of the drug Hu8F4 for treating patients with blood cancers. The drug may help stop cancer cells from growing and spreading.
Who is the study for?
This trial is for adults with advanced blood-related cancers like certain types of leukemia, myelodysplastic syndrome, or myelofibrosis. Participants must have specific genetic traits (HLA-A2), failed previous treatments, and be in good enough health to tolerate the study drug. Pregnant women are excluded and contraception is required during the trial.Check my eligibility
What is being tested?
The trial tests Hu8F4, a monoclonal antibody that may block cancer growth. It's in phase I to determine safe dosage levels and side effects. Patients will undergo lab biomarker analysis and pharmacological studies to see how well Hu8F4 works against their cancer.See study design
What are the potential side effects?
Potential side effects of Hu8F4 could include typical reactions seen with other monoclonal antibodies such as allergic reactions at the infusion site, fever, chills, nausea, fatigue, headache or more serious immune system related problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biologically-effective dose
Minimum safety data
Secondary outcome measures
Disease
Duration of complete remission
Event-free survival
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (Hu8F4)Experimental Treatment3 Interventions
Patients receive anti-PR1/HLA-A2 monoclonal antibody Hu8F4 IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,981 Previous Clinical Trials
1,789,659 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,703 Previous Clinical Trials
40,931,678 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,191 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Hu8F4)
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.
What do researchers wish to determine through this experiment?
"This 4 week trial will primarily evaluate the safety of a given medication. The secondary objectives include Event-free Survival, Duration of Complete Remission and Overall Survival which can be estimated using Kaplan-Meier methods."
Answered by AI
Is the research initiative currently recruiting participants?
"According to the clinicaltrials.gov registry, this medical trial is selecting participants at present. Initially posted on January 31st 2019, it was last modified by researchers on September 22nd 2022."
Answered by AI
Has the FDA sanctioned Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4?
"Our team has assessed the safety of Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4 with a score of 1 due to the limited data available from it's current Phase 1 trial."
Answered by AI
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