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Alkylating Agent
Veliparib + Temozolomide for Leukemia
Phase 1
Waitlist Available
Led By Ivana Gojo
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Relapsed or refractory pre-B- or T-cell acute lymphoblastic leukemia (ALL); patients with Philadelphia chromosome-positive (Ph+) ALL [t(9;22)] will be eligible provided that they have failed (intolerance/resistance) at least 2 different tyrosine kinase inhibitors (TKIs) or have a mutation associated with resistance to TKIs (T315I)
Chronic myelogenous leukemia (CML) in accelerated or blastic phase; patients failed (resistance/intolerance) at least 2 different TKIs or have a mutation associated with resistance to TKIs (T315I)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 6 hours after drug administration on day 1 of course 1
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of giving veliparib with temozolomide to treat leukemia. Veliparib may stop cancer cell growth by blocking enzymes needed for cell growth. Temozolomide may kill or stop cancer cells from dividing. Giving veliparib with temozolomide may kill more cancer cells.
Who is the study for?
This trial is for adults with various types of acute leukemia, including those who have relapsed or are not responding to other treatments. It's also open to older patients who can't undergo intensive chemotherapy and those with certain genetic mutations. Participants must be able to swallow pills, have no severe infections or illnesses that could interfere with the study, and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Veliparib and Temozolomide. The goal is to find the safest dose that effectively treats acute leukemia by blocking enzymes cancer cells need for growth while stopping their division. This phase I trial will also look at how these drugs affect biomarkers in lab tests.See study design
What are the potential side effects?
Potential side effects from Veliparib and Temozolomide may include allergic reactions similar to other compounds in their class, issues related to uncontrolled infections if present, heart problems like congestive heart failure or arrhythmias, psychiatric conditions affecting compliance, as well as risks associated with pregnancy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia has returned or didn't respond to treatment, and I've tried at least 2 TKIs without success.
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My CML is in an advanced stage and I've not responded to at least 2 TKIs or have a specific resistance mutation.
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I had a stem cell transplant over 60 days ago, have no graft vs. host disease, and stopped all immunosuppressive therapy over 2 weeks ago.
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I finished chemotherapy 3 weeks ago and radiotherapy 2 weeks ago, with no severe side effects.
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My AML has returned or didn't respond to treatment, including failure with tretinoin, arsenic, and gemtuzumab.
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I cannot undergo or have already tried all known curative treatments.
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I am 60 or older with AML and cannot undergo strong chemotherapy due to high-risk factors.
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My leukemia is caused by previous cancer treatments.
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My AML developed from a previous blood disorder.
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My leukemia is classified as CMML-2 based on my blood and bone marrow tests.
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I can take care of myself but might not be able to do heavy physical work.
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I am a woman who can have children and I have a negative pregnancy test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 6 hours after drug administration on day 1 of course 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 6 hours after drug administration on day 1 of course 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MTD of veliparib, determined according to incidence of dose limiting toxicity, graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Secondary outcome measures
Average change from baseline level in RAD51 foci
Average change from baseline level in y-H2AX foci
Average expression of MGMT
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (temozolomide and veliparib)Experimental Treatment4 Interventions
Patients receive veliparib PO QD on day 1 and twice daily on days 4-12 and temozolomide PO QD on days 3-9 of course 1.
Beginning at least 30 days after the start of treatment, patients receive veliparib PO BID on days 1-8 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients achieving complete remission receive 5 more courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Veliparib
2012
Completed Phase 3
~4820
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,087 Total Patients Enrolled
Ivana GojoPrincipal InvestigatorJohns Hopkins University/Sidney Kimmel Cancer Center
4 Previous Clinical Trials
131 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any ongoing infections that are not being treated.I do not have any severe illnesses that would stop me from following the study's requirements.I am HIV positive with a CD4 count over 250, not on zidovudine or stavudine.My leukemia has returned or didn't respond to treatment, and I've tried at least 2 TKIs without success.My CML is in an advanced stage and I've not responded to at least 2 TKIs or have a specific resistance mutation.I do not have active brain leukemia but may have had it in the past.I had a stem cell transplant over 60 days ago, have no graft vs. host disease, and stopped all immunosuppressive therapy over 2 weeks ago.I have a high white blood cell count and haven't used specific treatments for it in the last 24 hours.I am allergic to medications similar to ABT-888 or temozolomide.I finished chemotherapy 3 weeks ago and radiotherapy 2 weeks ago, with no severe side effects.I've had previous chemotherapy, but I'm still physically strong and my organs work well.I am not pregnant and will stop breastfeeding to receive treatment.I am not currently on any experimental treatments or receiving chemotherapy, radiation, or immunotherapy.My AML has returned or didn't respond to treatment, including failure with tretinoin, arsenic, and gemtuzumab.I cannot undergo or have already tried all known curative treatments.I am 60 or older with AML and cannot undergo strong chemotherapy due to high-risk factors.I am over 60 with untreated ALL and cannot have standard chemotherapy due to high-risk factors or my choice.I had a stem cell transplant more than 4 weeks ago and meet other study requirements.I agree to use effective birth control during and for 30 days after the study.I have stopped all my biologic treatments at least a week ago and have recovered from their side effects.I have been treated with temozolomide before.My leukemia is caused by previous cancer treatments.My AML developed from a previous blood disorder.My leukemia is classified as CMML-2 based on my blood and bone marrow tests.I can take care of myself but might not be able to do heavy physical work.I am a woman who can have children and I have a negative pregnancy test.I have undergone previous therapy for my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (temozolomide and veliparib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this the maiden voyage of such an investigation?
"Pharmacological Study has been under clinical examination since 2002, when Schering-Plough initiated the first trial involving 60 participants. Following successful Phase 2 approval of this drug, 224 studies across 1114 cities and 36 nations are presently underway."
Answered by AI
To what degree do the risks of participating in this pharmacological research outweigh the potential benefits?
"Due to the limited clinical data available, this pharmacological study was given a safety score of 1. This is because it only falls under Phase 1 trials and does not provide ample evidence for its efficacy or security."
Answered by AI
What is the estimated sample size for this medical experiment?
"This clinical trial is not accepting any more participants at this time. Initially posted on May 21st 2010 and modified lastly on June 28th 2022, it cannot accommodate new patients presently. Fortunately there are 2,665 studies searching for persons suffering from leukemia myeloid acute and 224 investigations that involve Pharmacological Study in need of individuals to join the research."
Answered by AI
Does this investigation still have open enrollment?
"According to the clinicaltrials.gov database, this trial is not actively seeking participants at present. Initially posted on May 21st 2010 and last updated June 28th 2022, no new patients are being sought for recruitment despite 2889 other trials currently recruiting individuals."
Answered by AI
What other pharmacological research has been undertaken to date?
"Pharmacological Study was initially explored in 2002 at Memorial Sloan Kettering Cancer Center. Up to this point, 906 trials have been completed and 224 additional studies are currently ongoing. Many of these experiments can be found taking place around Chicago, Illinois."
Answered by AI
What maladies does Pharmacological Study typically address?
"Participating in this research study can be beneficial for persons struggling with nitrosourea treatment, advance directives, and refractory, advanced mycosis fungoides issues."
Answered by AI
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