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HQP1351 for Leukemia
Study Summary
This trial is studying the side effects of HQP1351 in people with CML or Ph+ ALL who have resistance or intolerance to TKIs.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 111 Patients • NCT02393859Trial Design
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Who is running the clinical trial?
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- You have previously received a second-line TKI treatment, but it did not work for you.You have chronic myeloid leukemia (CML) in any phase (chronic, accelerated or blast crisis) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). You may or may not have a specific T315I mutation.You are expected to live for at least 3 more months.You have recently received other treatments that are not allowed in this study.You are currently taking medication to suppress your immune system, except for a short course of steroids.You have certain heart conditions that are listed in the criteria.You have received a stem cell transplant in the past or are currently taking medications to suppress your immune system.Six months after starting treatment, your BCR-ABL1 levels are higher than 10% or your Ph+ levels are higher than 35%.After starting treatment, you have not achieved complete hematologic response or have more than 95% Philadelphia chromosome positivity or new mutations within three months.You are allergic to any part of the study drug.You have been receiving treatment for six months, but your BCR-ABL1 levels are still high or you have developed new mutations.After three months of treatment, you did not respond well enough and still have a high level of abnormal cells.Your blood test shows high levels of BCR-ABL1 (more than 1%) or Ph+ (more than 0%) after a year of treatment.During the treatment and afterwards, if you have a decrease in CHR or complete cytogenetic response (CCyR), or a significant increase in the level of BCR-ABL1 transcripts with mutations or abnormal chromosomes in your Ph+ cells, you may not be eligible for the study.You had another type of cancer within the past year, except for nonmelanoma skin cancer or carcinoma in situ that were removed completely and have not returned.You are currently pregnant or breastfeeding.If you have a certain type of leukemia (Ph+ BCP ALL or CML LBP), you must have tried and not responded well to at least one type of medication (dasatinib, nilotinib, bosutinib, and ponatinib) before being eligible for this study.You have received treatment with at least two types of medication known as TKIs, but they did not work well for you or caused side effects. If you have a specific genetic mutation called T315I, there is no limit to the number of TKIs you have previously taken.
- Group 1: Cohort A
- Group 2: Cohort B
- Group 3: Cohort C
- Group 4: Cohort D
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the current enrollment count for this experiment?
"In order to carry out this clinical trial, Ascentage Pharma Group Inc. needs a total of 62 participants that meet the necessary criteria. The sponsor will be managing the study through sites such as Fred Hutchinson Cancer Research Center in Seattle, Washington and University of Texas MD Anderson Cancer Center located in Houston,Texas."
What risks are posed by the use of Blinatumomab for treatment?
"Due to limited data, we have assessed Blinatumomab's safety at a score of 1 out of 3. This is in accordance with the fact that this trial is still on its first phase and efficacy has yet to be fully established."
What else has been investigated concerning the effects of blinatumomab?
"Originally explored by Huazhong University of Science and Technology's Union Hospital medical college in 2018, blinatumomab has since been the focus of 15 concluded clinical trials. Currently, 5 ongoing studies are recruiting patients located predominantly in Seattle, Washington."
Is enrollment for this clinical trial currently available to eligible participants?
"According to the clinicaltrials.gov, this medical study is currently searching for suitable applicants. It was initially posted on 9th January 2020 and its last update was 8th July 2022."
Is this trial pioneering a new approach to therapy?
"Presently, 5 clinical trials for Blinatumomab are underway in 29 different cities and 2 nations. The initial examination of the drug was conducted by Ascentage Pharma Group Inc. in 2018; it involved 60 individuals and culminated with Phase 1 approval. Since then, 15 more examinations have been completed."
Are there a number of sites actively conducting this research study within the state?
"This research is enrolling patients at 8 sites, including Seattle, Houston and Baltimore. To reduce the amount of travel needed to participate in this trial, you may want to look for a location nearest your home."
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