ASTX727 + Donor Lymphocytes for Blood Cancers

Recruiting in Palo Alto (17 mi)

Overseen ByBetul Oran, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?To learn if ASTX727 given alone or in combination with donor lymphocyte infusion (DLI) can help to control certain types of hematological neoplasms (blood-based cancers) after a stem cell transplant.

Eligibility Criteria

This trial is for individuals who have undergone a stem cell transplant and are now dealing with certain types of blood cancers. Participants should meet specific health criteria set by the researchers to ensure they can safely receive the treatments being tested.

Inclusion Criteria

I am over 100 days post-transplant for AML/MDS with MRD detected.

I have AML or MDS and had a bone marrow or stem cell transplant.

I am between 18 and 75 years old.

+2 more

Exclusion Criteria

Use of any anti-leukemic agents after MRD is documented. Use of any of the following after transplantation and prior to starting study therapy for cohort #2. Overall grade II-IV acute GVHD. Chronic GvHD, moderate or severe by NIH criteria. Active uncontrolled systemic fungal, bacterial or viral infection. Symptomatic or uncontrolled arrhythmias. Significant active cardiac disease within the previous 6 months. Known active viral infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV). Prior history of solid tumors other than AML and MDS, unless the subject has been free of the disease for >/= 1 year. However, subjects with the following history/concurrent conditions are allowed: Basal or squamous cell carcinoma of the skin; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis [TNM] clinical staging system).

Participant Groups

The study is testing ASTX727, an oral medication, alone or combined with donor lymphocyte infusion (DLI), to see if it can control blood-based cancers after a stem cell transplant. It's in early stages (Phase I/II) to assess effectiveness and safety.

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment1 Intervention

If participants do not test positive for MRD, you will be enrolled in Group 2. Participants in this group will only receive ASTX727. If participants are enrolled in Group 2, the participant will take ASTX727 on Days 1-3 of each cycle.

Group II: Group 1Experimental Treatment2 Interventions

If participants test positive for minimal residual disease (MRD), participants will be enrolled in Group 1. MRD refers to small numbers of cancer cells that remain in the body during or after treatment. Participants in this group will receive ASTX727 and DLI. If participants are enrolled in Group 1, the participant will take ASTX727 on Days 1-4 of each cycle.

ASTX727 is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Inqovi for: