RECRUITING

A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts

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Conditions

Myelodysplastic SyndromesMyeloproliferative Chronic Myelomonocytic Leukemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To learn if the combination of cladribine, cytarabine, venetoclax, and azacitidine can help to control higher-risk myelodysplastic syndrome (MDS) with excess blasts and/or higher-risk chronic myelomonocytic leukemia (CMML).

Official Title

A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts

Quick Facts

Study Start:2022-09-23
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05365035

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \>/= 18 years.
  2. 2. Diagnosis of MDS or CMML by WHO and:
  3. * MDS relapsed cohort (Cohort A): MDS with Int-2 or High risk IPSS and \>5% blasts with no response after 6 cycles of azacitidine, decitabine, guadecitabine, CC-486 or ASTX727 (decitabine/cedazuridine) or relapse or progression after any number of cycles
  4. * CMML relapsed cohort (Cohort B): CMML 1 or 2 with no response after 6 cycles of azacitidine, decitabine, guadecitabine, CC-486 or ASTX727 (decitabine/cedazuridine) or relapse or progression after any number of cycles
  5. * MDS HMA-naïve cohort (Cohort C): MDS with Int-2 or High risk by IPSS and \>10% blasts OR diagnosis
  6. * CMML HMA-naïve cohort (Cohort D): CMML-2; OR CMML-1 with at least one of the following high-risk features: extramedullary disease, splenomegaly of \>5cm below costal margin, platelets \<100x109/L, Hgb level \<10g/dL, WBC \>13x109/L, clonal cytogenetic abnormality (other than monosomy Y).
  7. 3. Eastern Cooperative Oncology Group (ECOG) performance status of \</= 2
  8. 4. Creatinine clearance \> 30 ml/min no end/stage renal disease (using Cockcroft-Gault)
  9. 5. Adequate hepatic function with total bilirubin 2x ULN, AST or ALT 2.5 xULN unless deemed to be due to underlying disease involvement.
  10. 6. Willing to adhere to and comply with all prohibitions and restrictions specified in the protocol.
  11. 7. Patient must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study.
  12. 8. White blood cell (WBC) count \<50,000/L. Hydroxyurea may be used to control leukocytosis prior to C1D1. Use of hydroxyurea beyond this point may be permitted as clinically indicated, on a case-by-case basis and after discussion with the PI.
  13. 9. English and Non-English speaking patients will be allowed
  1. 1. Uncontrolled infection not adequately responding to appropriate antibiotics
  2. 2. New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF \<50% by echocardiogram or multigated acquisition (MUGA) scan.
  3. 3. History of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias.
  4. 4. Female patients who are pregnant or lactating.
  5. 5. Patients with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives \[birth control pills\], contraceptive injections, intrauterine devices \[IUD\], double-barrier method \[spermidical jelly or foam with condoms or diaphragm\], contraceptive patch, or surgical sterilization) throughout the study.
  6. 6. Female patients with reproductive potential who do not have a negative urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening.
  7. 7. Patients receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy.

Contacts and Locations

Study Contact

Guillermo Bravo, MD
CONTACT
(713) 794-3604
gmontalban1@mdanderson.org

Principal Investigator

Guillermo Bravo, MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Guillermo Bravo, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-23
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2022-09-23
Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Myelodysplastic Syndromes
  • Myeloproliferative Chronic Myelomonocytic Leukemia