30 Participants Needed

Decitabine + Lisaftoclax + Olverembatinib for Leukemia

NS
Overseen ByNicholas Short, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: M.D. Anderson Cancer Center
Must be taking: BCR::ABL1 TKI
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

To find the recommended doses of lisaftoclax and olverembatinib that can be given in combination with decitabine to participants with advanced CML and Ph+ AML.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have taken strong inducers of CYP3A or p-glycoprotein within 14 days before starting the study, and certain recent treatments are restricted. It's best to discuss your current medications with the study team.

What data supports the effectiveness of the drug combination Decitabine + Lisaftoclax + Olverembatinib for Leukemia?

Research shows that Decitabine, when combined with other drugs like venetoclax, has been effective in treating acute myeloid leukemia (AML), especially in older patients or those unfit for intensive chemotherapy. This combination has led to high rates of complete remission and improved overall survival in these patients.12345

What makes the drug combination of Decitabine, Lisaftoclax, and Olverembatinib unique for leukemia treatment?

This drug combination is unique because it combines Decitabine, which alters DNA methylation to promote cell differentiation, with Lisaftoclax and Olverembatinib, potentially offering a novel mechanism of action and improved outcomes for leukemia patients compared to existing treatments.12456

Research Team

Nicholas James Short | MD Anderson ...

Nicholas Short

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with advanced chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute myeloid leukemia (Ph+ AML). Participants should not have had previous treatments that failed. Specific health conditions and medications may exclude some individuals.

Inclusion Criteria

I am 18 or older with a specific type of leukemia.
My kidneys are working well enough (creatinine clearance β‰₯30 mL/min).
I have had a bad reaction or no response to a previous BCR-ABL1 TKI treatment.
See 6 more

Exclusion Criteria

Pregnant or breastfeeding women
Participants with psychiatric illness/social situations that would limit compliance with study requirements
I have no allergies to Decitabine, Lisaftoclax, Olverembatinib, or similar drugs.
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Participants receive varying doses of lisaftoclax in combination with decitabine and olverembatinib to establish the minimum safe and biologically-effective dose

4 cycles

Phase II Treatment

Participants receive lisaftoclax at the recommended dose found in Phase I, in combination with decitabine and olverembatinib

4 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and survival outcomes

1 year

Treatment Details

Interventions

  • Decitabine
  • Lisaftoclax
  • Olverembatinib
Trial Overview The study aims to determine the safe doses of lisaftoclax and olverembatinib when used together with decitabine in patients with advanced CML or Ph+ AML. It's an early-phase trial, meaning it's mostly about safety and finding the right dose.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment3 Interventions
Participants enrolled in Phase II, participants will receive lisaftoclax at the recommended dose that was found in Phase I
Group II: Phase 1Experimental Treatment3 Interventions
Participants enrolled in Phase I, the dose of lisaftoclax you receive will depend on when a participants join this study. Up to 2 dose levels of lisaftoclax will be tested. Between 3-12 participants will be enrolled at each dose level.

Decitabine is already approved in European Union, United States, Canada, Japan for the following indications:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Dacogen for:
  • Acute myeloid leukemia
  • Myelodysplastic syndromes
πŸ‡ΊπŸ‡Έ
Approved in United States as Dacogen for:
  • Myelodysplastic syndromes
  • Acute myeloid leukemia
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Approved in Canada as Dacogen for:
  • Myelodysplastic syndromes
  • Acute myeloid leukemia
πŸ‡―πŸ‡΅
Approved in Japan as Dacogen for:
  • Myelodysplastic syndromes
  • Acute myeloid leukemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Ascentage Pharma Group Inc.

Industry Sponsor

Trials
54
Recruited
5,700+

Findings from Research

In a comparison of two combination therapies for acute myeloid leukemiaβ€”glasdegib+low-dose cytarabine (LDAC) and venetoclax+LDACβ€”no statistically significant differences in overall survival or complete remission rates were found, suggesting similar efficacy.
When choosing between these treatments, factors like safety profiles, ease of administration, and patient preferences will be important since both therapies appear equally effective.
Comparative effectiveness of glasdegib versus venetoclax combined with low-dose cytarabine in acute myeloid leukemia.Tremblay, G., Daniele, P., Bell, T., et al.[2021]
A case of early-relapsed high-risk T-cell acute lymphoblastic leukemia (T-ALL) with high BCL-2 expression was successfully treated with a combination of decitabine and venetoclax, leading to complete remission (CR).
The results suggest that decitabine and venetoclax may work synergistically in treating BCL-2 positive acute lymphoblastic leukemia, indicating a potential new therapeutic strategy for this high-risk group.
Venetoclax in association with decitabine as effective bridge to transplant in a case of relapsed early T-cell lymphoblastic leukemia.Zappone, E., Cencini, E., Defina, M., et al.[2020]
In a study involving 145 older patients (median age 74) with acute myeloid leukemia (AML) who were ineligible for intensive chemotherapy, the combination of venetoclax with decitabine or azacitidine resulted in a high complete remission (CR) rate of 67%, demonstrating its efficacy in this challenging population.
The treatment was well tolerated, with no cases of tumor lysis syndrome reported, and the median overall survival was 17.5 months, indicating that venetoclax combined with hypomethylating agents is a promising option for elderly patients with AML.
Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia.DiNardo, CD., Pratz, K., Pullarkat, V., et al.[2021]

References

Comparative effectiveness of glasdegib versus venetoclax combined with low-dose cytarabine in acute myeloid leukemia. [2021]
Venetoclax in association with decitabine as effective bridge to transplant in a case of relapsed early T-cell lymphoblastic leukemia. [2020]
Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. [2021]
10-day decitabine with venetoclax for newly diagnosed intensive chemotherapy ineligible, and relapsed or refractory acute myeloid leukaemia: a single-centre, phase 2 trial. [2021]
The history of oral decitabine/cedazuridine and its potential role in acute myeloid leukemia. [2023]
A real-world study of infectious complications of venetoclax combined with decitabine or azacitidine in adult acute myeloid leukemia. [2022]
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