Venetoclax + Cladribine + Ruxolitinib for Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a combination of three drugs—ruxolitinib, cladribine, and venetoclax—can manage relapsed or refractory T-PLL, a specific type of leukemia. The study will evaluate how effectively these drugs work together to control the disease. It is best suited for patients previously treated for T-PLL without lasting results and who have not received T-PLL directed chemotherapy for at least a week. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this novel combination therapy.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking T-PLL directed chemotherapy or antibody therapy 7 days before starting ruxolitinib, but you may use hydroxyurea or decadron until 24 hours before starting the trial. The protocol does not specify other medication restrictions, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research is examining the safety of using a combination of three drugs—venetoclax, cladribine, and ruxolitinib—to treat leukemia. Past patients who took these drugs experienced varied outcomes. For instance, one study found that individuals using venetoclax and cladribine lived for about 5.8 months on average. This indicates some effectiveness, but the safety information is still under review.
Regarding side effects, some studies have shown that people can tolerate these drugs, though reactions vary. Ruxolitinib is already approved for other uses, providing some insight into its safety. However, more research is needed to understand how well people tolerate the combination with cladribine and venetoclax.
In summary, while previous uses of these drugs provide some safety evidence, the current trial aims to gather more detailed information. Participants should be aware that safety results can vary for each individual.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Venetoclax, Cladribine, and Ruxolitinib for leukemia because these drugs target cancer cells in unique ways. Venetoclax works by inhibiting a protein called BCL-2, which helps cancer cells survive, leading to their death. Cladribine is a chemotherapy agent that integrates into DNA, disrupting cancer cell growth. Ruxolitinib targets and blocks specific enzymes involved in cancer cell signaling pathways. This multi-pronged approach aims to tackle leukemia more effectively than standard treatments, which typically focus on single pathways or mechanisms.
What evidence suggests that this trial's treatments could be effective for leukemia?
Research shows that combining the drugs venetoclax, cladribine, and ruxolitinib may help treat certain types of leukemia. In this trial, participants will receive this combination treatment. Studies have found that venetoclax, when used with other drugs, can significantly decrease cancer cells in the bone marrow. One study showed that patients who received this combination treatment lived for a median of 5.8 months. The goal of this combination is to effectively control the disease by targeting and killing cancer cells. While more data is still being collected, early results suggest this treatment could benefit patients with hard-to-treat forms of leukemia.12346
Who Is on the Research Team?
Tapan Kadia, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with T-cell Prolymphocytic Leukemia that has come back or didn't respond to treatment. They should not have had specific leukemia treatments for at least a week before starting this study, but some exceptions apply. Participants need good liver and kidney function, a certain level of platelets, and a decent heart ejection fraction. People with other cancers can join if it doesn't affect the trial's safety or results.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Ruxolitinib, Cladribine, and Venetoclax. The first cycle is administered on an inpatient basis, with subsequent cycles potentially on an outpatient basis.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cladribine
- Ruxolitinib
- Venetoclax
Trial Overview
The study tests combining three drugs: ruxolitinib, cladribine, and venetoclax in patients whose T-PLL has relapsed or is refractory (not responding to treatment). The aim is to see if this drug combo can control the disease better than current treatments.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive treatment on an inpatient basis for the first cycle and can be administered on an outpatient basis for the subsequent cycles.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Citations
Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in ...
The goal of this clinical research study is to learn if the combination of ruxolitinib with cladribine and venetoclax can help to control the ...
A Phase II Trial of Venetoclax in Combination with ...
Low relapse rates following SCT translate to an estimated overall survival of 71% at 4 years in patients with newly diagnosed AML. CLIA- ...
Venetoclax combined with cladribine in patients ...
At the time of data review, 1 patient was alive at 8.3 months. The median overall survival (OS) was 5.8 months. Conclusions: The combination of ...
Single-center experience with venetoclax combinations in ...
Marrow remission in newly diagnosed and relapsed post–MPN-AML patients treated with venetoclax-containing regimens was 43% and 0%, respectively.
Venetoclax + Cladribine + Ruxolitinib for Leukemia
The goal of this clinical research study is to learn if the combination of ruxolitinib with cladribine and venetoclax can help to control ...
Efficacy and safety of cladribine, low-dose cytarabine ...
The efficacy of the venetoclax-based regimen in R/R AML was not satisfactory, with a remission rate of 21% and a median survival of 3.0 months ...
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