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Biological Response Modifier
Beta Alethine for Waldenstrom Macroglobulinemia
Phase 1 & 2
Waitlist Available
Research Sponsored by LifeTime Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Renal criteria: Creatinine no greater than 2.0 mg/dL, Creatinine clearance at least 60 mL/min
No clinical signs or evidence of active brain involvement or leptomeningeal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will study the effectiveness of beta alethine in treating patients with Waldenstrom's macroglobulinemia.
Who is the study for?
This trial is for patients with Waldenstrom's macroglobulinemia, a type of lymphoma. Participants must have a confirmed diagnosis, measurable monoclonal protein levels in urine or blood, and show an immune response to skin testing. It's open to those who haven't yet needed treatment for their indolent (slow-growing) disease.Check my eligibility
What is being tested?
The study is evaluating the effectiveness of beta alethine, a biological therapy designed to stimulate the immune system and halt cancer cell growth. This phase I/II trial aims to determine how well beta alethine works against Waldenstrom's macroglobulinemia.See study design
What are the potential side effects?
While specific side effects for beta alethine are not listed here, biological therapies can commonly cause flu-like symptoms, fatigue, fever, chills, weakness and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is good, with creatinine under 2.0 mg/dL and clearance over 60 mL/min.
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My cancer has not spread to my brain or its coverings.
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I am 18 years old or older.
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I can perform most of my daily activities without assistance.
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My heart is healthy with no recent issues, uncontrolled chest pain, heart failure, or irregular heartbeat.
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I have been diagnosed with Waldenstrom's macroglobulinemia.
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My liver function tests are within the required range.
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
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Who is running the clinical trial?
LifeTime PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
1 Trials studying Lymphoma
Suzin Mayerson, PhDStudy ChairLifeTime Pharmaceuticals
2 Previous Clinical Trials
1 Trials studying Lymphoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is slow-growing and doesn't need treatment yet.My kidney function is good, with creatinine under 2.0 mg/dL and clearance over 60 mL/min.It's been over 4 weeks since my last chemotherapy, and I haven't had high-dose treatments.I haven't taken corticosteroids in the last 4 weeks and am not currently taking any.I am not taking any experimental drugs, immunosuppressants, or anti-inflammatory medications including aspirin.I can perform most of my daily activities without assistance.My heart is healthy with no recent issues, uncontrolled chest pain, heart failure, or irregular heartbeat.My cancer has not spread to my brain or its coverings.I haven't had immunotherapy, cytokines, plasmapheresis, or a stem cell transplant in the last 4 weeks.It's been over 4 weeks since my last radiotherapy that affected a large part of my bone marrow.I am 18 years old or older.I have recovered from all my past surgeries and have not had an organ transplant.I have been diagnosed with Waldenstrom's macroglobulinemia.My liver function tests are within the required range.
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 researchers recruiting participants for this experiment right now?
"Unfortunately, this study is no longer recruiting patients for participation as noted on clinicaltrials.gov. Although this specific trial is not enrolling, there are 1,790 other studies that are still looking for volunteers."
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