BridgeMD
New treatment option for Acute Myeloid Leukemia (AML)
Official title Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML
ClinicalTrials.gov ID: NCT02781883
What this study is testing
What is BP1001 in combination with Ventoclax plus decitabine?
BP1001 in combination with Ventoclax plus decitabine is an investigational medicine, being studied as a potential treatment for acute myeloid leukemia (aml).
Also referred to as Liposomal Grb-2, L-Grb-2.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objectives of this study are to assess: (1) whether the combination of BP1001 plus venetoclax plus decitabine provides greater efficacy (Complete Remission [CR], Complete Remission with incomplete hematologic recovery [CRi], Complete Remission with partial hematologic recovery [CRh], than venetoclax plus decitabine alone (by historical comparison) in participants with untreated AML that cannot or elect not to be treated with more intensive chemotherapy; (2) whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory/relapsed AML.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At the time of Screening, participants must meet all of the following criteria to be considered eligible to participate in the study:
- Adults ≥18 years of age
- Females must be of non-childbearing potential, surgically sterile, postmenopausal, or practice adequate methods of contraception during the study and...
- Males must agree to use an adequate method of contraception during the study and for at least 30 days after the last dose of study drug or decitabine
- Histologically documented diagnosis (based on the 2008 World Health Organization [WHO] Classification) (Vardiman et al. 2009) of one of the following:
You likely can't join if
- At the time of Screening, participants who meet any of the following criteria will be excluded from participating in the study:
- Active non-hematologic or lymphoid malignancy other than AML treated with immuno- or chemotherapy within the previous 12 months except active non-...
- Known, active leptomeningeal leukemia requiring intrathecal therapy. NOTE: Patients with a history of CNS disease may be allowed to participate based...
- Isolated extramedullary leukemia without also meeting bone marrow criteria for acute leukemia (for AML usually = 20% blasts in BMA or BMB). Patients...
- Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) PML-RARA
- Chronic myeloid leukemia (CML) in any phase
See the full eligibility criteria
Who can join
- At the time of Screening, participants must meet all of the following criteria to be considered eligible to participate in the study:
- Adults ≥18 years of age
- Females must be of non-childbearing potential, surgically sterile, postmenopausal, or practice adequate methods of contraception during the study and for 30 days after the last dose of study drug or decitabine
- Males must agree to use an adequate method of contraception during the study and for at least 30 days after the last dose of study drug or decitabine
- Histologically documented diagnosis (based on the 2008 World Health Organization [WHO] Classification) (Vardiman et al. 2009) of one of the following:
- Newly diagnosed untreated AML; or
- Untreated secondary AML, including AML that has progressed from MDS
- In some cases of AML associated with specific genetic abnormalities, however, the diagnosis of AML may be made if the blast count is less than 20% (Dohner et al. 2017) - specifically AML with t(15;17), t(8;21), inv(16)...
- Relapsed or Refractory AML
- Investigator considers previously untreated participant ineligible for (or unwilling to receive) intensive induction therapy based on medical reasons, disease characteristics such as genetics, type of AML (untreated or...
- Eligible for venetoclax and decitabine therapy, based on Investigator assessment
- Participant's WBC count is 25 x 10\^9/L or less at study initiation. The use of leukapheresis or hydroxyurea before treatment initiation to achieve this is permitted.
- Adequate hepatic and renal functions as defined by:
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN); and
- Usually total bilirubin ≤ 1.5 ULN. In specific cases the PI may request a waiver of this requirement with medical justification and agreement with the medical monitor and Bio-Path holdings. And;
- Estimated glomerular filtration rate (eGFR) of at least 40 ml/min. These estimations can be calculated using any of the following methods (Appendix E: Formulas): i. Chronic Kidney Disease Epidemiology Collaboration...
- GFR = 141 × min (Scr /κ, 1)\^α × max(Scr /κ, 1)\^-1.209 × 0.993\^Age × 1.018 [if female] × 1.159 [if black] ii. Cockcroft gault equation
- Cockcroft Gault equation utilizing the TBW (Total body weight) to calculate an estimated creatinine clearance
- CrCl = [(140 - age) x TBW] / (Scr x 72) x 0.85 [if female] iii. Modification of Diet in Renal Disease (MDRD) Study equation
- GFR (mL/min/1.73 m\^2) = 175 × (Scr)\^-1.154 × (Age)\^-0.203 × 0.74 [if female] x 1.212 [if African American (AA)] iv. Creatinine clearance estimated by 24-hr urine collection for creatinine clearance
- Documented Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment
- Willing and able to provide written informed consent 7.2.
What rules you out
- At the time of Screening, participants who meet any of the following criteria will be excluded from participating in the study:
- Active non-hematologic or lymphoid malignancy other than AML treated with immuno- or chemotherapy within the previous 12 months except active non- melanoma, non-invasive skin cancer will be allowed.
- Known, active leptomeningeal leukemia requiring intrathecal therapy. NOTE: Patients with a history of CNS disease may be allowed to participate based on at least 1 documented, negative spinal fluid assessment within 28...
- Isolated extramedullary leukemia without also meeting bone marrow criteria for acute leukemia (for AML usually = 20% blasts in BMA or BMB). Patients may have leukemia with lower blast counts (Dohner et al. 2010)...
- Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) PML-RARA
- Chronic myeloid leukemia (CML) in any phase
- Receipt of any anti-cancer therapy within 14 days prior to C1D1, with the exception of hydroxyurea or anagrelide (within 24 hours), TKI (within 1day), a single dose of cytarabine (for proliferative disease)
- Uncontrolled active, untreated, or progressive infection
- Receipt of any investigational agent or study treatment within 30 days prior to C1D1
- Females who are capable of becoming pregnant, test positive for pregnancy, or are breast-feeding during the Screening period, or intend to become pregnant or breast-feed during the course of the study or within 30 days...
- Serious intercurrent medical or psychiatric illness which, in the opinion of the Investigator, would interfere with the ability of the participant to complete the study
- Known active or clinically significant hepatitis B infection (based on positive surface antigen [HBsAg]), hepatitis C infection (based on positive antibody [HCV Ab]), or human immunodeficiency virus (HIV-1 or HIV-2...
- History of any hypersensitivity to venetoclax or decitabine, unless reaction is deemed irrelevant to the study by the Investigator and Medical Monitor
- Presence of concurrent conditions that, in the opinion of the Investigator and/or Medical Monitor, may compromise the participant's ability to tolerate study treatment or interfere with any aspect of study conduct or...
- Within the past 6 months, has had any of the following: myocardial infarction, unstable angina pectoris, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack
- Uncontrolled seizure disorder (i.e., seizures within the past 2 months)
- Cannot receive live attenuated vaccine immunization prior to, during, or after treatment with venetoclax until B-cell recovery occurs
- Unable or unwilling to communicate or cooperate with the Investigator or follow the protocol for any reason
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Augusta, Georgia, United States
- Fairway, Kansas, United States
- Brick, New Jersey, United States
- New York, New York, United States
- Houston, Texas, United States
- Temple, Texas, United States
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Augusta, Georgia, United States; Fairway, Kansas, United States; Brick, New Jersey, United States; New York, New York, United States; Houston, Texas, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.