Uproleselan for Neoplasm Metastasis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Neoplasm Metastasis+4 More
Uproleselan - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of chemotherapy drugs may help treat secondary acute myeloid leukemia.

See full description

Eligible Conditions

  • Neoplasm Metastasis
  • Secondary Acute Myeloid Leukemia (Secondary AML, sAML)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Neoplasm Metastasis

Study Objectives

This trial is evaluating whether Uproleselan will improve 2 primary outcomes and 13 secondary outcomes in patients with Neoplasm Metastasis. Measurement will happen over the course of From date of CR/CRi to date of disease relapse, death or last follow-up, whichever occurred first, assessed up to 4.5 years.

Year 5
Remission duration
Year 5
Progression-free survival
Year 5
Overall survival
Up to 4.5 years
CR with partial hematologic recovery
CR without blood count recovery (CRi)
Complete response (CR)
Incidence of adverse events
Induction mortality
Morphologic leukemia-free state
Overall response rate
Partial response
Rate of complete cytogenetic response
Rate of minimal residual disease (MRD) negativity
Recommended phase II dose
Toxicity

Trial Safety

Safety Progress

1 of 3

Other trials for Neoplasm Metastasis

Trial Design

1 Treatment Group

Treatment (uproleselan, cladribine, cytarabine)
1 of 1
Experimental Treatment

This trial requires 37 total participants across 1 different treatment group

This trial involves a single treatment. Uproleselan is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Treatment (uproleselan, cladribine, cytarabine)INDUCTION THERAPY: Patients receive uproleselan IV over 20 minutes on day 1 and Q 12 hours on days 2-12, cladribine IV over 1-2 hours on days 1-5 and cytarabine SC BID on days 1-10 in the absence of disease progression or unacceptable toxicity. Patients who do not achieve a CR or CRi after cycle 1 may receive a second induction cycle. CONSOLIDATION/MAINTENANCE THERAPY: Patients receive uproleselan IV over 20 minutes on day 1 and Q12 hours on days 2-1. Patients who have achieved at least CR/CRi or morphologic leukemia-free state after induction therapy receive uproleselan IV QD on days 1-12. Patients also receive cladribine IV over 1-2 hours on days 1-3 and cytarabine SC BID on days 1-10. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cladribine
FDA approved
Uproleselan
Not yet FDA approved
Cytarabine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4.5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 4.5 years for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with a diagnosis of treated secondary-AML (TS-AML) who have not received therapy for their AML will be eligible
TS-AML is defined as AML arising from a previously treated antecedent myeloid neoplasm (myelodysplastic syndrome or myeloproliferative neoplasm)
Age >= 18 years
Total bilirubin =< 2mg/dL
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN) - or < 5 x ULN if related to leukemic involvement
Creatinine =< 1.5 x ULN
Known cardiac ejection fraction of > or = 45% within the past 6 months
Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
A negative urine or serum pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial
Patient must have the ability to understand the requirements of the study and informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol

Patient Q&A Section

What is leukemia, myeloid, acute?

"Leukemia, myeloid, acute is a type of blood cancer.\nLeukemia is a group of blood cancer that starts in the bone marrow. Different kinds of leukemia have different types of symptoms which might include a continuous feeling of tiredness, feeling hot, feeling fatigued, feeling a lot of thirst and the feeling of tiredness and being fainter might happen.\nMeadowdale Hospital (now known as Meadowvale Hospital) was the first hospital in New Zealand for patients with leukaemia and it is located in the suburb of Meadowvale. In the early-1950s, the institution in Meadowvale became the first public hospital in New Zealand to use antibiotics to treat its patients." - Anonymous Online Contributor

Unverified Answer

Can leukemia, myeloid, acute be cured?

"AML/MDS are not curable. At present, there are no cures for AML, which is a highly lethal disease. Long-term studies are necessary to better understand leukemogenesis in order to develop new therapies, including gene therapy. Results from a recent paper of future treatment are unlikely to be known by this criterion." - Anonymous Online Contributor

Unverified Answer

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

"Between 4 and 8 people per year get leukemia, myeloid, acute. This is comparable to the mortality (2.1 per year, 5-11 per 100,000 population) and incidence (6.3 per 100 million population) of leukemia. The incidence of myeloid leukemia is 1.7 times the incidence of leukemia, irrespective of demographic subgroups." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia, myeloid, acute?

"Some non-randomized trials suggest that aspirin is ineffective in people with acute leukemias; however, randomized trials are not available that compare aspirin to current standard management for acute leukemias. There are no randomized trials comparing aspirin-containing chemotherapy regimens to active chemotherapy for acute myeloid leukemia. No randomized trials support the use of statins for people with acute myeloid leukemia." - Anonymous Online Contributor

Unverified Answer

What are the signs of leukemia, myeloid, acute?

"Signs such as pale appearance, dry skin, weight loss, fever, and enlargement of lymph node or bone are the most common signs of leukemia, myeloid, acute." - Anonymous Online Contributor

Unverified Answer

What causes leukemia, myeloid, acute?

"In individuals with no family history of cancer, it is likely that both genetic and environmental factors result in a single case of leukemia, myeloid, acute." - Anonymous Online Contributor

Unverified Answer

Does leukemia, myeloid, acute run in families?

"Families with leukemia have a family history of leukemia more than 2 years before the first case. Therefore, an individualized clinical evaluation is needed in familial cases of AML." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets leukemia, myeloid, acute?

"About 38.3% of people who get leukemia (or myeloid, acute) will be more than 49 years of age. In general, leukemia patients who are more than 47 years have good survival chances compared to patients less than 47 years of age. Older patients generally have good survival.\n\nA common cancer to come across is Non-Hodgkin’s Tumor or NHT (T-L). They are a group of cancers that are formed by white blood cells rather than non-purple blood cells." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of uproleselan?

"The common side effects seem to be similar in leukemic and nonleukemic populations treated with lenalidomide, but the patients with myelogenous leukemia appear to run a higher risk of side effects." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for leukemia, myeloid, acute?

"The majority of patients eligible for clinical trials were not eligible based on eligibility criteria. Clinical trials for Leukemia, Myeloid Acute, are often used both to enroll new patients and for data-collection purposes for patients already in the treatment process." - Anonymous Online Contributor

Unverified Answer

What is uproleselan?

"The study results corroborate the hypothesis of a new melanocortin-related peptide. On the other hand, these peptides, which are under preliminary investigation, could possibly be mediators of tumor growth. Findings from a recent study clearly show that melanocortins need to be evaluated further in patients with myeloid diseases." - Anonymous Online Contributor

Unverified Answer

Has uproleselan proven to be more effective than a placebo?

"The study has confirmed that uproleselan (in combination with duloxetine hydrochloride) is more effective than a placebo against pain relief induced by oral administration of morphine. Neither uproleselan nor duloxetine hydrochloride was more effective than a placebo when given alone as analgesics. Uroplus was associated with more nausea and VOM." - 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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