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Anti-sense Oligonucleotide

BP1002 + Decitabine for Acute Myeloid Leukemia

Phase 1
Recruiting
Led By Gail J Roboz, MD
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
Adults ≥18 years of age, with histologic evidence of refractory/relapsed AML who have failed treatment with available therapies known to be active for refractory/relapsed AML
Eastern Cooperative Oncology Group (ECOG) Performance Status 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 cancer treatment, BP1002, on patients with a certain type of leukemia that has returned or does not respond to treatment. They will be testing how safe and tolerated the BP1002 is in different doses and if it has any anti-cancer effects.

Who is the study for?
Adults over 18 with refractory/relapsed AML who've failed other treatments can join. They must have a decent performance status (ECOG 0-2), good liver and kidney function, agree to birth control, and be recovered from past cancer therapies. Excluded are those with certain leukemia types, recent anti-cancer therapy, HIV/AIDS or hepatitis B/C infections, pregnant or breastfeeding women, hypersensitivity to similar drugs, uncontrolled health issues like heart disease.Check my eligibility
What is being tested?
The trial is testing BP1002 alone in escalating doses for safety and tolerability initially. After that phase, it will test BP1002 combined with decitabine to find the effective dose range and observe any potential benefits against AML.See study design
What are the potential side effects?
Potential side effects of BP1002 may include reactions at the infusion site, fatigue, nausea or changes in blood counts leading to increased infection risk. Decitabine might cause low blood cell counts as well as fever and pneumonia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 and my AML has not responded to treatment.
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I am able to care for myself and perform daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~210 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 210 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine anti-drug antibody (ADA) levels of BP1002
Determine half-life plasma pharmacokinetics (PK) of BP1002
Determine pharmacodynamics (PD) of BP1002
+8 more
Secondary outcome measures
Assessment of blast count reductions by complete blood counts using peripheral blood
Assessment of morphologic leukemia free state (MLFS) and partial remissions by bone marrow aspirate
Assessment of morphologic leukemia free state (MLFS) and partial remissions by bone marrow aspirate and complete blood counts
+3 more
Other outcome measures
Exploratory objective to correlate treatment response with cytogenetic characteristics
Exploratory objective to correlate treatment response with molecular characteristics

Trial Design

2Treatment groups
Experimental Treatment
Group I: Relapsed/Refractory AML - BP1002 monotherapyExperimental Treatment1 Intervention
BP1002 monotherapy dose escalation
Group II: Relapsed/Refractory AML - BP1002 in combination with decitabineExperimental Treatment2 Interventions
BP1002 single dose in combination with decitabine

Find a Location

Who is running the clinical trial?

Bio-Path Holdings, Inc.Lead Sponsor
5 Previous Clinical Trials
248 Total Patients Enrolled
Gail J Roboz, MDPrincipal InvestigatorWeill Cornell Medical College - New York-Presbyterian Hospital

Media Library

BP1002 (Anti-sense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05190471 — Phase 1
Acute Myelogenous Leukemia Research Study Groups: Relapsed/Refractory AML - BP1002 monotherapy, Relapsed/Refractory AML - BP1002 in combination with decitabine
Acute Myelogenous Leukemia Clinical Trial 2023: BP1002 Highlights & Side Effects. Trial Name: NCT05190471 — Phase 1
BP1002 (Anti-sense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05190471 — Phase 1

Frequently Asked Questions

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

What is the ultimate purpose of this investigation?

"This clinical trial requires a 30 day evaluation period and aims to detect changes in conduction or rhythm (e.g. treatment-induced QTc elevations) of escalating doses of BP1002. Secondary objectives include identification of response as evidenced by bone marrow aspirate according to Döhner 2017, reduction in blast count per Williams 2016, and evidence for complete remission (CR), CR with incomplete hematologic recovery (CRi), and CR with partial hematologic recovery (CRh)."

Answered by AI

Has BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide been evaluated in other investigations?

"Currently, 102 trials utilizing BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide have been initiated. 15 of these studies are at the Phase 3 stage. While most of these experiments are centred in Philadelphia, Pennsylvania, a total of 1483 locations worldwide have participated in this clinical research endeavour."

Answered by AI

Has the FDA granted authorization for BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide?

"Our team at Power assigned BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide a score of 1 since this is only a Phase 1 trial, indicating there is scant evidence to back up its safety and efficacy."

Answered by AI

Is this research endeavor accepting new participants?

"According to the posted data on clinicaltrials.gov, this trial is open for enrolment and has been since its original posting date of August 16th 2022. As recently as October 27th 2022, changes were made to the study’s details."

Answered by AI

What is the scope of enrollment for this medical trial?

"Affirmative. Documents hosted on clinicaltrials.gov demonstrate that this research endeavour, which was first published on August 16th 2022, is actively seeking individuals to enrol in the study. Approximately 48 participants will be recruited from 2 distinct sites."

Answered by AI

For what medical condition is BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide most frequently prescribed?

"BP1002, also known as Liposomal Bcl-2 Antisense Oligodeoxynucleotide, is an appropriate treatment for intermediate-2 IPSS risk category patients, those with high IPSS scores and refractory anaemias."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)
2022. "A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05190471.
~18 spots leftby Apr 2025
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