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New treatment option for Leukemia
Official title Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
ClinicalTrials.gov ID: NCT01515527
What this study is testing
What is Cladribine?
Cladribine is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for leukemia.
Also referred to as Leustatin, 2-CdA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- Cohort 1
- Patients with previously untreated AML or high risk MDS (\>/= 10 % blasts or IPSS \>/= intermediate-2). Prior therapy with hydroxyurea, hematopoietic...
- 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)
You likely can't join if
- Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects...
- Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure...
- 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...
- Creatinine \>/= 2 mg/dL
- Total bilirubin \>/= 2 mg/dL
See the full eligibility criteria
- Cohort 1
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.