Is NCT04708054 recruiting in Houston, TX?

Yes, NCT04708054 is currently recruiting participants at its Houston, TX location. This acute myeloid leukemia clinical trial is actively enrolling qualified participants.

How do I join the acute myeloid 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.

Acute Myeloid Leukemia Clinical Trial in Houston, TX

About This Acute Myeloid Leukemia Study in Houston

This phase II trial studies the effect of venetoclax together with busulfan, cladribine, and fludarabine in treating patients with high-risk acute myeloid leukemia or myelodysplastic syndrome who are undergoing stem cell transplant. Chemotherapy drugs, such as venetoclax, busulfan, cladribine, and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax to the current standard of care stem cell transplant regimen of busulfan, fludarabine, and cladribine may help to control high-risk acute myeloid leukemia or myelodysplastic syndrome.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

Inclusion Criteria

Age ≥ 18 and ≤ 70 years. English and non-English speaking patients are eligible.

Patients with acute myeloid leukemia who have previously received induction therapy and one of the following high-risk features:

ELN17 adverse risk prognostic group irrespective of remission status (see Appendix 2)

Measurable residual disease positive (MRD +)

Not in complete remission including complete remission without count recovery (Cri) and/or morphologic leukemia free state (MLFS), primary refractory, or relapsed disease. See Appendix 3 for details.

AML secondary to MDS or MPD

Therapy-related AML.

Not in complete remission after one course of induction therapy Or Patients with myelodysplastic syndrome or CMML and one of the following high-risk features:

Poor or Very poor cytogenetic risk group as per IPSS-R

Mutated P53 or Ras pathway genes (CBL, NRAS, KRAS, NF1, PTPN1) or DNMT 3a or ASXL1 or RUNX1

Maximum IPSS-R \>3.5 between diagnosis and the start of the preparative regimen.

≥ 5% BM blasts at transplant

Therapy-related MDS

HLA-identical sibling or a minimum of 7/8 matched unrelated donor, or a haploidentical related donor available

Subject must voluntarily sign an informed consent

Female subjects of childbearing potential must have negative results for pregnancy test

Adequate hepatic and renal function per local laboratory reference range as follows:

Aspartate transaminase (AST) and alanine transaminase (ALT) \< 3.0X ULN

Bilirubin \<1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)

Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 50 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection. Phase III

Age ≥ 18 and ≤ 65 years. English and non-English speaking patients are eligible.

Patients with acute myeloid leukemia who have previously received induction therapy and one of the following high-risk features:

ELN22 adverse risk prognostic group irrespective of remission status (see Appendix

Measurable residual disease positive (MRD +) including MRD + any time after induction therapy.

Not in complete remission including complete remission without count recovery (Cri) and/or morphologic leukemia free state (MLFS), primary refractory, or relapsed disease. See Appendix 4 for details.

AML secondary to MDS or MPD

Therapy-related AML.

Not in complete remission after one course of induction therapy

Second or higher complete remission Or Patients with myelodysplastic syndrome and one of the following high-risk features:

Poor or Very poor cytogenetic risk group as per IPSS-R

Mutated P53 or Ras pathway genes (CBL, NRAS, KRAS, NF1, PTPN11) or ASXL1 or RUNX1 or moderate high, or high, or very high-risk group as per IPSS-M

Maximum IPSS-R \>3.5 between diagnosis and the start of the preparative regimen.

≥ 5% BM blasts at transplant

Therapy-related MDS Or Patients with CMML

HLA-identical sibling or a minimum of 7/8 matched unrelated donor

Subject must voluntarily sign an informed consent

Female subjects of childbearing potential must have negative results for pregnancy test

Adequate hepatic and renal function per local laboratory reference range as follows:

Aspartate transaminase (AST) and alanine transaminase (ALT) \< 3.0X ULN

Bilirubin \<1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)

Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 50 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.

Exclusion Criteria

Subject is known to be positive for HIV.

Subject has cognitive impairments and/or is a prisoner.

Subject has acute promyelocytic leukemia

Subject has known active CNS involvement with AML.

Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:

Uncontrolled and/or active systemic infection (viral, bacterial or fungal)

Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate.

Cardiac history of CHF requiring treatment or Ejection Fraction \< 50% or unstable angina;

Corrected DLCO \< 50% or FEV1 \<65%.

Administration or consumption of any of the following within 3 days prior to the first dose of study drug:

grapefruit or grapefruit products

Seville oranges (including marmalade containing Seville oranges)

Patients with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures.

Prior allogeneic stem cell transplantation.

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 (NCT04708054) 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.

Acute Myeloid Leukemia Treatment Options in Houston, TX

If you're searching for acute myeloid leukemia treatment options in Houston, TX, this clinical trial (NCT04708054) 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 acute myeloid 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 acute myeloid leukemia clinical trials near you to find additional studies recruiting in your area.

Acute Myeloid Leukemia Clinical Trial in Houston, TX

Expert Care in Houston

IRB Approved

No-Cost Care

Apply for This Houston Location

Why Participate?

Simple Process