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Antisense Oligonucleotide
BP1002 for Lymphoma
Phase 1
Recruiting
Research Sponsored by Bio-Path Holdings, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females must be of non-childbearing potential, surgically sterile, postmenopausal, or practice adequate methods of contraception during the study
Eastern Cooperative Oncology Group (ECOG) Performance score of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 210 days
Awards & highlights
Study Summary
This trial is testing a new drug for patients with advanced lymphoma who have relapsed or are resistant to treatment. Up to 12 patients will be given the drug and monitored for safety and effectiveness.
Who is the study for?
Adults over 18 with advanced lymphoid malignancies that have not responded to or returned after treatment, including various types of lymphoma and leukemia. Participants must be expected to live at least 3 months, have good liver and kidney function, and use contraception if applicable. They should not be eligible for certain other cancer treatments.Check my eligibility
What is being tested?
The trial is testing BP1002 (L-Bcl-2 antisense oligonucleotide) for safety, how the body processes it, and its effectiveness in treating patients with relapsed or refractory lymphoid malignancies. Up to 12 patients will receive this experimental therapy.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions associated with antisense oligonucleotides such as injection site reactions, flu-like symptoms, fatigue, fever, nausea and potential liver enzyme elevations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot become pregnant, am surgically sterile, postmenopausal, or use reliable birth control.
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I can take care of myself and am up and about more than half of my waking hours.
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My lymphoma came back or didn't fully respond to treatment.
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I've tried or can't use standard treatments, including stem cell transplant and CAR T-cell therapy.
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My liver and kidney tests are within normal ranges.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 210 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~210 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine half-life plasma pharmacokinetics (PK) of BP1002
Determine pharmacokinetics (PK) of BP1002
Determine plasma pharmacokinetics (PK) of BP1002 using elimination rate constant
+7 moreSecondary outcome measures
Activity of BP1002 on Bcl-2 expression in tumor samples
Determine estimates for event-free survival (EFS)
Determine estimates for progression-free survival (PFS)
+3 moreOther outcome measures
Exploratory objective to correlate treatment response with cytogenetic characteristics
Exploratory objective to correlate treatment response with molecular characteristics
Trial Design
1Treatment groups
Experimental Treatment
Group I: BP1002 monotherapyExperimental Treatment1 Intervention
L-Bcl-2 Antisense oligonucleotide (BP1002) is given in a sequential, dose escalation design. Starting dose is 20mg/m^2.
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Who is running the clinical trial?
Bio-Path Holdings, Inc.Lead Sponsor
5 Previous Clinical Trials
266 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You have a current infection of hepatitis B, hepatitis C, or HIV.I cannot become pregnant, am surgically sterile, postmenopausal, or use reliable birth control.I can take care of myself and am up and about more than half of my waking hours.My lymphoma came back or didn't fully respond to treatment.I do not have any untreated or uncontrolled infections.You are expected to live for at least 3 more months.I do not need therapy in my spinal fluid for brain involvement of my cancer.I've tried or can't use standard treatments, including stem cell transplant and CAR T-cell therapy.I am not pregnant, breastfeeding, nor plan to become pregnant or breastfeed during the study.I have recovered from previous cancer treatments, except for hair loss.I haven't had treatment for cancer, except for non-melanoma skin cancer, in the last year.I agree to use birth control during the study.I am able and willing to follow study instructions and communicate with the research team.My liver and kidney tests are within normal ranges.I haven't received any cancer treatment in the last 14 days.I am eligible for high dose chemotherapy and a stem cell transplant using my own cells.I have a slow-growing type of non-Hodgkin lymphoma.I am at high risk for TLS due to a large tumor or high lymphocyte count.I have not had a heart attack, stroke, or similar event in the last 6 months.I have seizures that are not controlled by medication.I have a diagnosis of a specific type of lymphoma or leukemia.
Research Study Groups:
This trial has the following groups:- Group 1: BP1002 monotherapy
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.
What is the participant capacity of this trial?
"Affirmative. The information hosted on clinicaltrials.gov divulges that this medical trial, which was initially posted on November 5th 2020, is actively looking for candidates. To date, 30 people need to be enrolled across 1 centre."
Answered by AI
What are the intended outcomes of this clinical investigation?
"As detailed by Bio-Path Holdings, Inc., the main outcome of this trial to be assessed within a 30 day period is discovering the Recommended Phase 2 dose (RP2D) of BP1002. Additionally, secondary research objectives involve determining Time to Progression (TTP), examining tumor response via bone marrow aspirate and Complete Blood Counts (CBC) with appropriate uniform criteria as defined by Response Evaluation Criteria in Lymphoma (RECIL) 2017, CLL guidelines, and International Workshop on Waldenström's Macroglobulinemia (IWWM 6th)."
Answered by AI
Could you provide information regarding the current enrollment status of this research?
"Indeed, information available on clinicaltrials.gov affirms that this medical trial is actively recruiting patients. Initially posted on November 5th 2020 and most recently updated 18th of the same month; 30 individuals need to be accepted from a single site."
Answered by AI
Is there an official sanctioning of L-Bcl-2 antisense oligonucleotide by the Food and Drug Administration?
"Due to the limited amount of data concerning safety and efficacy, our team at Power gave L-Bcl-2 antisense oligonucleotide an estimation score of 1."
Answered by AI
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