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Monoclonal Antibodies
Gemtuzumab for Myelodysplastic Syndrome
Phase 2
Waitlist Available
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed myelodysplastic syndrome (MDS) including Refractory anemia (RA), RA with ringed sideroblasts, RA with excessive blasts (RAEB), RAEB in transformation (stable disease for at least 2 months)
Performance status: ECOG 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well gemtuzumab works in treating patients with myelodysplastic syndrome.
Who is the study for?
This trial is for adults with myelodysplastic syndrome (MDS), specifically those without certain chromosomal abnormalities or chronic myelomonocytic leukemia. Participants must have an IPSS score of at least 1.5 and stable disease for a minimum of two months. They should not have received prior chemotherapy, stem cell transplantation, or be on immunosuppressive therapy.Check my eligibility
What is being tested?
The trial is testing the effectiveness of gemtuzumab, a monoclonal antibody designed to target and kill tumor cells in MDS patients while sparing healthy cells. This phase II study randomly assigns participants to receive gemtuzumab to evaluate its impact on their condition.See study design
What are the potential side effects?
Potential side effects include reactions where the drug enters the body, damage to normal cells leading to low blood counts, increased risk of infections due to immune system suppression, liver problems like elevated bilirubin levels, and possibly severe cardiac issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is a type of blood disorder known as myelodysplastic syndrome.
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I am able to get out of my bed or chair and move around.
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I do not have severe lung disease.
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I have not had cancer before, except for skin cancer.
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I do not have any infections that aren't responding to treatment.
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I am 18 years old or older.
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My bilirubin level is below 1.5 mg/dL.
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My kidney function is good with creatinine below 2.0 mg/dL.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,153 Total Patients Enrolled
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,075 Total Patients Enrolled
Gary J. Schiller, MDStudy ChairJonsson Comprehensive Cancer Center
5 Previous Clinical Trials
35 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before, but it wasn't skin cancer.I do not have any infections that are not responding to treatment.I haven't had growth factor or cytokine therapy in the last 4 weeks.I have had chemotherapy for MDS or another cancer.I am currently receiving chemotherapy that kills cancer cells.My white blood cell count is over 12,000, indicating proliferative CMML.I have severe lung disease.I haven't taken systemic steroids in the last 4 weeks, except for creams or inhalers.I haven't taken immunosuppressive drugs in the last 4 weeks.My condition is a type of blood disorder known as myelodysplastic syndrome.I am able to get out of my bed or chair and move around.I do not have severe heart disease.I do not have severe lung disease.I have not had cancer before, except for skin cancer.I do not have any infections that aren't responding to treatment.My MDS has spread to my brain.I am not taking any steroids except for creams or inhalers.My cancer has specific genetic changes.I have previously received anti-CD33 antibodies treatment.I have a serious heart condition.I have had radiation therapy for myelodysplastic syndrome or another cancer.I have had a stem cell transplant before.I will use birth control during and for 1 year after the study.I am 18 years old or older.I have had an organ transplant.I am currently on medication to suppress my immune system.My blood counts meet the trial's requirements.My bilirubin level is below 1.5 mg/dL.My kidney function is good with creatinine below 2.0 mg/dL.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are participants being recruited for this medical experiment at the moment?
"Clinicaltrials.gov informs that this clinical trial, which first began recruiting on the 1st of September 2001 and last updated its information over half a decade ago, is no longer in recruitment mode. Despite this unfortunate fact, there are an abundance of medical studies actively looking for patients at present - 1595 in total."
Answered by AI
Has this particular remedy earned governmental sanction?
"Due to the fact that this is a phase 2 trial, our team at Power has assigned it with an estimation of safety level 2 on a scale from 1-3. This represents data supporting its security but no evidence yet backing up efficacy."
Answered by AI
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