Is NCT01515527 recruiting in Houston, TX?

Yes, NCT01515527 is currently recruiting participants at its Houston, TX location. This leukemia clinical trial is actively enrolling qualified participants.

How do I join the leukemia clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Leukemia Clinical Trial in Houston, TX

About This Leukemia Study in Houston

The goal of this clinical research study is to learn if cladribine given in combination with low-dose cytarabine (LDAC) and decitabine can help control the disease in patients with AML or MDS. The safety of this drug combination will also be studied. Cladribine is designed to interfere with the cell's ability to process DNA (the genetic material of cells). It can also insert itself into the DNA of cancer cells to stop them from growing and repairing themselves. Cytarabine is designed to insert itself into DNA of cancer cells to stop them from growing and repairing themselves. Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die. This is an investigational study. Cladribine is FDA approved and commercially available for use in patients with hairy cell leukemia. Its use in patients with AML is investigational. Cytarabine is FDA approved and commercially available for use in patients with AML. Decitabine is FDA approved and commercially available for use in patients with MDS. Its use for patients with AML is investigational. Up to 160 patients will take part in this study. All will be enrolled at MD Anderson.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

Inclusion Criteria

Patients with previously untreated AML or high risk MDS (\>/= 10 % blasts or IPSS \>/= intermediate-2). Prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, ATRA, or total dose of cytarabine up to 2g is allowed. Patients with history of MDS transformed to AML are eligible regardless of their prior therapy for MDS provided this will be their first induction therapy for AML.

Age \>/= 60 years. Patients aged \< 60 years who are unsuitable for standard induction therapy may be eligible after discussion with PI

Adequate organ function as defined below:

liver function (bilirubin \< 2mg/dL, AST and/or ALT \<3 x ULN)

kidney function (creatinine \< 1.5 x ULN ).

ECOG performance status of ≤ 2.

A negative urine 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 signed informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol.

Prior therapy with decitabine will be allowed unless the patient experienced progression to AML while being treated with decitabine.

Exclusion Criteria

Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.

Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Patient with documented hypersensitivity to any of the components of the chemotherapy program.

Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. Cohort 2 Inclusion Criteria: 8\. Patients with previously untreated AML who are not currently eligible for other frontline clinical trials of AML therapy. Prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, ATRA, or total dose of cytarabine up to 2g is allowed. Patients with history of MDS transformed to AML are eligible regardless of their prior therapy for MDS provided this will be their first induction therapy for AML. 9\. Age \>/= 18 years who are unsuitable for standard induction therapy are eligible after discussion with PI 10. Patients must have one of the following:

Creatinine \>/= 2 mg/dL

Total bilirubin \>/= 2 mg/dL

ECOG Performance Status equal to 3 or 4

Is ineligible for participation in a protocol of higher priority 11. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. 12\. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol. 13\. Prior therapy with decitabine will be allowed unless the patient experienced progression to AML while being treated with decitabine. Exclusion Criteria: 5\. Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided. 6\. Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, unless these illnesses are judged to be related to the underlying leukemia. 7\. Patient with documented hypersensitivity to any of the components of the chemotherapy program. 8\. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. Cohort 3 Inclusion Criteria:

Patients with relapsed and or refractory AML who have received at least one prior therapy for their AML.

Age \>/= 18 years.

Adequate organ function as defined below:

liver function (bilirubin \< 2mg/dL, AST and/or ALT \<3 x ULN)

kidney function (creatinine \< 1.5 x ULN ).

ECOG performance status of ≤ 2.

A negative urine 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 signed informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol.

Prior therapy with venetoclax will be allowed. Exclusion Criteria

Patient with documented hypersensitivity to any of the components of the chemotherapy program. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT01515527) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Leukemia Treatment Options in Houston, TX

If you're searching for leukemia treatment options in Houston, TX, this clinical trial (NCT01515527) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all leukemia clinical trials near you to find additional studies recruiting in your area.

Leukemia Clinical Trial in Houston, TX

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