CYC065 for Myelodysplastic Syndromes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
MD Anderson Cancer Center, Houston, TX
Myelodysplastic Syndromes+2 More
CYC065 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of two drugs may be more effective than either drug alone for individuals with a certain type of leukemia.

See full description

Eligible Conditions

  • Myelodysplastic Syndromes
  • MDS
  • Acute Myeloid Leukemia (AML)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Myelodysplastic Syndromes

Study Objectives

This trial is evaluating whether CYC065 will improve 1 primary outcome, 2 secondary outcomes, and 1 other outcome in patients with Myelodysplastic Syndromes. Measurement will happen over the course of At the end of cycle 1 (each cycle is 28 days).

Day 28
Maximum tolerated dose (MTD)
Pharmacodynamic effect
Pharmacokinetic effect
Week 4
Anti-tumor activity

Trial Safety

Safety Progress

1 of 3

Other trials for Myelodysplastic Syndromes

Trial Design

1 Treatment Group

CYC065 and venetoclax
1 of 1
Experimental Treatment

This trial requires 25 total participants across 1 different treatment group

This trial involves a single treatment. CYC065 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 and are in the first stage of evaluation with people.

CYC065 and venetoclaxCYC065 will be administered intravenously via 4-hour infusion on Day 1 and Day 15. Venetoclax will be taken daily on Day 1 through Day 15. One cycle will be 28 days or 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from the date of first dose of cyc065 to 4 weeks after the last dose of cyc065
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from the date of first dose of cyc065 to 4 weeks after the last dose of cyc065 for reporting.

Closest Location

MD Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Myelodysplastic Syndromes or one of the other 2 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Previously treated AML or MDS based on WHO classification and having at least 10% blasts in peripheral blood
ECOG 0-2
Adequate renal function
Adequate liver function
INR <=1.2 in patients not receiving chronic anticoagulation
At least 2 weeks from prior cytotoxic chemotherapy, radiation therapy, major surgery or other investigational cancer therapy
Agree to practice effective contraception

Patient Q&A Section

Can myelodysplastic syndromes be cured?

"With good treatment, some patients can be cured, the more favorable the demographic characteristics of the patients, and the better the underlying disease response to treatment. Patients who attain the criteria for the "curable" category did so by the age at which they were diagnosed." - Anonymous Online Contributor

Unverified Answer

How many people get myelodysplastic syndromes a year in the United States?

"Approximately 2,000 cases are diagnosed annually; the incidence of MDS ranges from 0.4 percent of all adult patients in the US to about 1 percent in the population of patients with hematological diseases. This suggests that the diagnosis of MDS is relatively common, but the actual incidence is low." - Anonymous Online Contributor

Unverified Answer

What is myelodysplastic syndromes?

"Patients with MDS have a greater risk of solid tumors such as lung cancer and may have a more aggressive disease, especially if low-grade or higher-grade dysplasia is present. These data suggest active follow-up and careful patient management is advised by the clinician." - Anonymous Online Contributor

Unverified Answer

What are common treatments for myelodysplastic syndromes?

"The common treatments for the MDS have not changed recently. There is a need to develop new types of therapies to treat the MDS. New treatments can improve the survival rates and quality of life of patients with MDS. Aspects of this issue are discussed here.(c)(c)." - Anonymous Online Contributor

Unverified Answer

What are the signs of myelodysplastic syndromes?

"When evaluating individuals with MDS, a careful history and physical examination are imperative for selecting patients who would most benefit from bone marrow biopsy and appropriate treatment. The physical signs of MDS are similar to those of the general healthy population, but often more subtle and subtle.\n" - Anonymous Online Contributor

Unverified Answer

What causes myelodysplastic syndromes?

"Recent studies have found a number of environmental and genetic risk factors for these conditions.\n\nmTORC1 activators may be clinically effective in reducing cancer mortality in myelodysplastic syndromes.\n" - Anonymous Online Contributor

Unverified Answer

Is cyc065 safe for people?

"Cyc065 has been approved by the EMA for the treatment of refractory neutropenia in people with high-risk myelodysplastic syndrome and refractory chronic myelomonocytic leukemia. Considering cyc065 is widely used in clinical practice, it seems appropriate to determine the safety of cyc065 for healthy children. Because cyc065 is known to be effective in patients with high-risk myelodysplastic syndrome and refractory chronic myelomonocytic leukemia, the safety of cyc065 would appear to be acceptable." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating myelodysplastic syndromes?

"Treatment of myelodysplastic syndromes is often not very effective and many patients will eventually transform into acute myeloid leukemia. In order to prevent the development of this disease,

myelodysplastic syndromes must be treated. Currently, it is not clear what specific therapy affects risk for evolution towards acute myeloid leukemia. The disease itself does not progress with an increase in the number of blasts in the blood smear; however, it has been demonstrated that when an individual is treated for a myelodysplastic syndrome, the rate of progression of the disease may be accelerated." - Anonymous Online Contributor

Unverified Answer

Has cyc065 proven to be more effective than a placebo?

"Based on cyc065 clinical trial results, there is a positive association between cyc065 and improvement in MDS symptoms at doses up to 15 and 30 mg/day; subjects taking 30 mg/day cyc065 experienced greater improvement in MDS symptoms than did those taking a placebo on an as of December 2017. These data suggest that cyc065 may have clinical utility in MDS." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving cyc065?

"Cyc065 showed a favorable safety profile and no activity of cyc065 in patients with active relapsed or refractory MDS, including patients after transplantation. In accordance with the FDA announcement, cyc065 was suspended from further clinical testing." - Anonymous Online Contributor

Unverified Answer

How serious can myelodysplastic syndromes be?

"Acute decompensated illness in relation to MDS is commonly severe with significant complications but does not appear to have any appreciable impact on long-term overall survival. Thus these patients can expect to suffer their MDS-related morbidity but be expected to live longer than if they had never experienced MDS." - Anonymous Online Contributor

Unverified Answer

Does myelodysplastic syndromes run in families?

"Although a common finding in hereditary disorders like Fanconi anemia, little evidence has been presented to support the occurrence of multiple cases of MDS in some families. We report three families in whom MDS presenting early in life was noted in more than one member of the same family, and two families presenting with adult-onset disease. Whether this supports a genetic component remains speculative." - 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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