Laboratory Biomarker Analysis for Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Cincinnati Medical Center, Cincinnati, OH
Leukemia+3 More
Laboratory Biomarker Analysis - Other
Eligibility
18+
All Sexes
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Study Summary

This study is evaluating whether genomic screening followed by assignment to a multi-study protocol may help identify new treatments for leukemia.

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Eligible Conditions

  • Leukemia
  • Previously Untreated Acute Myeloid Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Laboratory Biomarker Analysis will improve 3 primary outcomes and 3 secondary outcomes in patients with Leukemia. Measurement will happen over the course of 7 days.

7 days
Proportion of patients assigned to a novel therapeutic treatment group in 1 of several sub-studies in this Master Protocol, based on the result of the molecular, immunophenotypic, and/or biochemical studies
Proportion of patients enrolled on this trial that ultimately will be assigned and go onto an assigned therapy
Proportion of patients for whom molecular, immunophenotypic, and/or biochemical studies are completed in < 7 calendar days for assignment of treatment
Up to 5 years
Clinical response rate (rate of complete and partial responses) according to International Working Group criteria for treatment outcomes in therapeutic trials in acute myeloid leukemia
Relationships between baseline functional status and response rate or progression-free survival based on graphical comparison (eg, side-by-side boxplots or Kaplan-Meier plots)
Year 1
Dynamic changes in clonal architecture over time in acute myeloid leukemia patients receiving targeted therapies

Trial Safety

Safety Progress

1 of 3

Trial Design

14 Treatment Groups

BAML-16-001-S4 (Closed)
1 of 14
BAML-16-001-S3
1 of 14
BAML-16-001-S18
1 of 14
BAML-16-001-S8
1 of 14
BAML-16-001-S10 (Closed)
1 of 14
BAML-16-001-S17
1 of 14
BAML-16-001-S9 (Closed)
1 of 14
BAML-16-001-S16 (Closed)
1 of 14
BAML-16-001-S14
1 of 14
BAML-16-001-S18 (Closed)
1 of 14
BAML-16-001-S2
1 of 14
BAML-16-001-S6
1 of 14
BAML-16-001-S1 (Closed)
1 of 14
BAML-16-001-S5 (Closed)
1 of 14
Experimental Treatment

This trial requires 2000 total participants across 14 different treatment groups

This trial involves 14 different treatments. Laboratory Biomarker Analysis is the primary treatment being studied. Participants will be divided into 14 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

BAML-16-001-S4 (Closed)This is a 2 cohort phase 1b/2 clinical trial to assess the feasibility and efficacy of entospletinib (ENTO) stepwise approach to the treatment of patients with balanced translocations of MLL identified cytogenetically (Cohort 1) and patients with MLL-partial tandem duplications identified molecularly (Cohort 2). All enrolled participants will be initiated on monotherapy with ENTO 400 mg PO BID. This dose will be administered continuously in 28 day cycles.
BAML-16-001-S3This is a phase 2 clinical trial to assess the feasibility and efficacy of a stepwise approach to the treatment of IDH2-mutant AML. On day 1 of the trial, all enrolled participants will be initiated on therapy with the IDH2 inhibitor AG-221 for IDH2 R140 and R172-mutant patients. The dosing will be based on phase 1 experience of AG-221, which has established 100 mg daily as a safe and tolerated dose, with preliminary suggestion of efficacy. These will be administered continuously in 28 day cycles. Hydroxyurea will be allowed for the purposes of cytoreduction.
BAML-16-001-S18This is an open-label Phase 1b clinical study of AZD5991 + azacitidine in patients aged ≥60 years with newly diagnosed, previously untreated, hypermethylated and marker-negative AML. The phase 1b1 study will adopt a standard 3+3 design with dose escalation based upon dose limiting toxicities. The recommended Phase 2 dose (RP2D) is defined in this study as the highest dose level where less than 2 dose limiting toxicities (DLT) are observed out of 6 patients. Once the RP2D is defined, patients will be enrolled into 2 separate cohorts (hypermethylation and marker negative group) for the phase 1b2 expansion. These 2 groups will both be treated at the RP2D determined from phase 1b1.
BAML-16-001-S8This is an open-label Phase 1b/2 clinical study of gilteritinib monotherapy, gilteritinib in combination with decitabine, or gilteritinib in combination with decitabine and venetoclax in untreated FLT3 mutated AML with high and low variant allele frequency. Initially, the combination of gilteritinib and decitabine was tested (Group 1); however, subsequently the combination of decitabine and venetoclax was shown to be a highly effective therapy for older AML patients, so the triple combination of gilteritinib in combination with decitabine and venetoclax (Group 2) is now being evaluated in this study.
BAML-16-001-S10 (Closed)This is a phase 1b/2 clinical trial to assess the safety and efficacy of the combination of AZD5153 and venetoclax. In a phase 1b component, safety and tolerability of the combination will be assessed in relapsed/refractory AML patients ≥ 18 years of age. Following determination of the recommended Phase 2 dose (RP2D), newly diagnosed, marker negative patients age ≥ 60 will be enrolled in the phase 2 component; these patients will be treated at the previously identified RP2D for the combination. The RP2D will be the highest dose level with ≤ 1 out of 6 patients with dose limiting toxicity and defined as the maximum tolerated dose.
BAML-16-001-S17This is an open-label Phase 1b dose escalation and expansion clinical trial to determine the safety and recommended dose of SNDX-5613 combined with azacitidine and venetoclax in newly diagnosed, untreated AML patients age ≥ 60 years who are not candidates or do not wish to pursue intensive induction therapy and who have NPM1 mutated/FLT3-ITD and FLT3-TKD wild type or MLL-rearranged disease. After determination of the recommended dose of SNDX-5613, the study will have an expansion cohort to be treated at the recommended dose in combination with azacitidine and venetoclax in the same patient population.
BAML-16-001-S9 (Closed)This is an open-label phase 2 clinical trial of a stepwise approach to the treatment of patients with TP53 mutation AML. On day 1, all enrolled participants will be initiated on therapy with pevonedistat (20 mg/m2) day 1, 3 and 5 together with azacitidine (75 mg/m2 days 1-7 or day 1-5 then day 8, 9) every 28 days. During cycle 1, patients with rapidly progressive disease or severe organ dysfunction, not correctable by hydroxyurea cytoreduction will not be eligible to continue. Those patients who achieved a response, defined as complete response or complete response with incomplete blood count recovery, by the end of cycle 4 will continue on pevonedistat and azacitidine until disease progression, unacceptable toxicity, or 12 cycles of therapy. After 12 months of combined therapy, pevonedistat will be continued until progression of disease, unacceptable toxicity, or up to 2 years of total therapy.
BAML-16-001-S16 (Closed)This is an open-label phase 2 clinical study to assess the feasibility and efficacy of a combination based approach to the treatment of IDH1 mutant AML. On day 1 of the trial, all enrolled participants will be initiated on therapy with the IDH1 inhibitor AG-120 given daily together with azacitidine (days 1-5 and 8-9 or 7 consecutive days 1-7) in 28 day cycles for IDH1 mutant patients. Those patients who have achieved a response, defined as complete response or complete response with incomplete blood count recovery, by the end of cycle 6, will continue on combination therapy for a total of 12 cycles and then patients will go onto receive monotherapy with AG-120 until disease progression or unacceptable side effects that mandate discontinuation of therapy. Patients who cannot complete 12 cycles of azacitidine may proceed onto monotherapy with AG-120.
BAML-16-001-S14The study is an open-label Phase 1b/2 clinical study of TP-0903 given in addition to decitabine in patients ≥ 60 years with newly diagnosed, previously untreated AML with TP53 mutations and/or complex karyotype. The Phase 1b portion of this study will use a standard 3 + 3 design with dose escalation based upon dose limiting toxicities. The maximum tolerated dose will be defined as the highest dose where at most 1 patient in 6 experiences dose-limiting toxicity, and this is generally the recommended Phase 2 dose (RP2D). Once the RP2D is determined from Phase 1b, patients will be enrolled at this dose level to initiate the Phase 2 portion of the study.
BAML-16-001-S18 (Closed)This is an open-label Phase 1b clinical study of AZD5991 + azacitidine in patients aged ≥60 years with newly diagnosed, previously untreated, hypermethylated and marker-negative AML. The phase 1b1 study will adopt a standard 3+3 design with dose escalation based upon dose limiting toxicities. The recommended Phase 2 dose (RP2D) is defined in this study as the highest dose level where less than 2 dose limiting toxicities (DLT) are observed out of 6 patients. Once the RP2D is defined, patients will be enrolled into 2 separate cohorts (hypermethylation and marker negative group) for the phase 1b2 expansion. These 2 groups will both be treated at the RP2D determined from phase 1b1.
BAML-16-001-S2This is an open-label Phase 1b/2 clinical study of BI 836858 given in combination with azacitidine, followed by BI 836858 plus azacitidine maintenance, in newly diagnosed acute myeloid leukemia. The target population is assigned by the Beat AML Master Protocol (the "umbrella" study). Eligible patients will have previously untreated acute myeloid leukemia, age greater than or equal to 60, with any 1 of the following: mutated TET2, IDH1, IDH2, or WT1, or "marker negative" as defined by the overall Beat AML umbrella protocol.
BAML-16-001-S6The study is an open-label phase 2 study of entospletinib in younger and older AML patients with NPM1+/FLT3ITD-AML. It includes patients age ≥18 years who are able and willing to receive 7 + 3 intensive chemotherapy. Entospletinib is administered daily with IV daunorubicin (days 1-3 for Cycle 1) and cytarabine (days 1-7 for Cycle 1). If a second induction is required, it is given with IV daunorubicin (days 1-2 for Cycle 2) and cytarabine (days 1-5 for Cycle 2).
BAML-16-001-S1 (Closed)This is an open-label Phase 1b/2 clinical study of Samalizumab given in addition to standard induction chemotherapy/consolidation, followed by Samalizumab maintenance, in newly diagnosed acute myeloid leukemia. Patients that are marker negative, as defined based on the Beat AML Master Protocol assignment or with CBF karyotype/interphase cytogenetics/molecular testing defined by presence of t(8;21)(q22;q22) or the molecular equivalent RUNX1/RUNX1T1 fusion transcript or inv(16)(p13q22) or t(16;16)(p13;q22) or the molecular equivalent CBFB/MYH11 fusion transcript based on the Beat AML will receive Samalizumab in combination with induction therapy followed by Samalizumab maintenance.
BAML-16-001-S5 (Closed)This is a phase 2 clinical trial to assess the feasibility and efficacy of a stepwise approach to the treatment of patients with TP53 mutations (identified molecularly) with/without complex karyotype (Cohort A) or complex karyotype (3 or greater metaphase abnormalities without TP53) (Cohort B). All enrolled participants will be initiated on entospletinib 400 mg orally twice daily. This dose will be administered continuously in 28 day cycles.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

University of Cincinnati Medical Center - Cincinnati, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia or one of the other 3 conditions listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Cohort Inclusion Criteria - Group A: Subjects must have previously untreated AML according to the WHO classification with blasts in bone marrow of 10% to 19% or blasts in blood of 10% to 19% show original
Subjects in Group B had relapsed or refractory AML, which is defined as having never achieved a CR or recurrence of AML within 6 months of achieving CR show original
Patients who are not in a specific known cytogenetic and genomic group for which treatment in Group A or B is allowed by the sub-study where age 18 and older is allowed, but are 60 years or older at the time of diagnosis, will be followed on the Master Protocol and not considered screen failures show original
Subjects must be able to understand and provide written informed consent

Patient Q&A Section

What are the signs of leukemia?

"These signs may include easy bruising or bleeding, swollen lymph nodes, easy fatigue, easy bruising or bleeding, easy bruising or bleeding, and fast heart rate. Symptoms that are not indicative of acute leukemia are more likely signs of cancer. As signs are not a diagnostic criterion they cannot be used to diagnose acute leukemia; they are, however, useful to identify patients at risk of having more serious health problems and to monitor their health for irregularities or problems that warrant urgent medical attention. Patients typically have one or more of these signs. Occasionally, signs of acute leukemia can be present but not reported, such as fever or bone pain (particularly in early disease), and they can occur on top of any other symptoms." - Anonymous Online Contributor

Unverified Answer

What is leukemia?

"Leukemia is a cancer of the blood and bone marrow that is diagnosed following the development of bleeding, a fever, or the development of symptoms. This type of cancer is diagnosed in approximately 30% of children and 10% of adults diagnosed with cancer. leukemia.com\n" - Anonymous Online Contributor

Unverified Answer

What causes leukemia?

"There are multiple causes of leukemia. It can generally be divided into two types of neoplasms, malignant lymphomas and leukemic cell lymphomas. The causes of leukemia are diverse and can be broadly subdivided into: genetic factors; environmental factors; hematologic disease (such as dysplasia, and myelodysplastic syndrome (MDS)), and immunologic disorders. Infection is a cause of leukemia that is also a risk factor for developing other malignancies, especially lymphoma and solid tumor." - Anonymous Online Contributor

Unverified Answer

Can leukemia be cured?

"Most of the cancers that are currently treated can be very effectively cured if they are identified and removed before they have spread to other organs and sites. Even for the most common forms of leukemia, cure is achievable. The cure is usually complete, or nearly so, in many forms of leukemia. The cure rate is higher for acute forms of leukemia (80-90%) than for chronic forms (70-80%). In many cases of chronic forms of leukemia, long-term remission (cured disease) is possible, but the disease usually returns if treatment is stopped." - Anonymous Online Contributor

Unverified Answer

How many people get leukemia a year in the United States?

"About 1 out of every 100,000 people suffers a new onset of leukemia annually. Women are affected more often than men. The chance of getting leukemia increases with age at onset. Children who have or acquire ALL are at highest risk for leukemia." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia?

"For all-comers, treatment for [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia) involves chemoimmunotherapy-related chemotherapeutic agents. In acute myeloid leukemia, both treatment styles utilize conventional chemotherapy drugs, but most cases also involve targeted therapy agents. Treatment of acute lymphocytic leukemia may also involve non-chemotherapeutic drugs in combination with chemotherapy therapy. All forms of treatment of chronic myeloid leukemia are usually non-curative. All-comers are treated with surgery, and less-aggressive cases (such as early-stage chronic myelogenous leukemia) may also require chemotherapy." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving laboratory biomarker analysis?

"As most laboratories utilize different assays to measure serum c-Jun N-terminal kinases, we will evaluate the level of serum kinase activity using immunoassay to allow comparison between assays or when they differ." - Anonymous Online Contributor

Unverified Answer

What is the latest research for leukemia?

"What you learn from the scientific research into leukemia in recent years is that there is no such thing as a miracle chemotherapeutic agent. Chemotherapy to treat patients is highly demanding and difficult to achieve. The development of more effective medicines is very rewarding for scientists. The development of targeted therapy, which could be regarded as the “ultimate cancer drug” is just as exciting. This form of chemotherapy, especially target therapy that inhibits or inhibits cancer cell growth, is particularly in need of development. In this review we will show you what scientists believe targeting chemotherapy or targeted therapy can do for human cancer patients. There are a lot of hurdles to overcome in the development of targeted therapy to treat cancer." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for leukemia?

"Most patients in this study were elderly and they expressed minimal understanding of trial procedures. Physicians should explain trial procedures and trial potential benefits/harm in an approach that is compatible with patients' ability to understand. Clinicians must also be aware of what potential questions and worries patients have, particularly about the nature of a drug regimen or the length of an intensive therapy regimen." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets leukemia?

"The average age a person gets leukemia is about 10.5 years of age. However, not all leukemia may develop until age 10, which would mean that the majority of the people who are diagnosed with leukemia at age 10 are already in remission." - Anonymous Online Contributor

Unverified Answer

Does laboratory biomarker analysis improve quality of life for those with leukemia?

"Significant increases in QoL were evident in survivors of leukemia who completed labbiomarker analysis compared with those who did not. LabBiomarker Analysis is becoming a standard part of diagnostic workup. While the impact on treatment decisions remains unclear, labBiomarkers are bringing important clinical, economic and research benefits for survivors of cancer." - Anonymous Online Contributor

Unverified Answer

What does laboratory biomarker analysis usually treat?

"Recent findings, we identified specific laboratory biomarkers tested for in each case that are useful in selecting the optimal therapy for each patient and can guide treatment recommendations for both newly diagnosed patients and for previously treated patients. It will soon be possible to use similar strategies to identify patient-specific therapeutic biomarkers for use in clinical trials, particularly for clinical trials that include patients with previously treated AML." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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