Pomalidomide + Chemotherapy for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen byJoshua F Zeidner

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing if adding pomalidomide to standard chemotherapy can improve treatment for patients with a specific type of newly diagnosed leukemia. Pomalidomide works by cutting off the blood supply to cancer, boosting the immune system, and killing cancer cells. The chemotherapy drugs attack cancer cells in multiple ways. Pomalidomide is related to thalidomide and has shown remarkable activity in patients who did not respond to other treatments.

Research Team

Joshua F Zeidner

Principal Investigator

Ohio State University Comprehensive Cancer Center LAO

Eligibility Criteria

Adults aged 18-75 with newly diagnosed acute myeloid leukemia (AML) and specific genetic mutations or changes related to myelodysplastic syndrome, who have good organ function and performance status. They must not have had previous AML treatment except hydroxyurea or leukapheresis, no Wilson's Disease, uncontrolled illnesses, prior allogeneic stem cell transplant, or certain cumulative doses of daunorubicin. Women of childbearing potential must test negative for pregnancy and use two forms of birth control.

Inclusion Criteria

Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 x institutional ULN

My leukemia is classified as therapy-related or stems from a previous blood disorder.

My leukemia diagnosis was confirmed with a specific test showing more than 20% immature blood cells.

See 40 more

Exclusion Criteria

Patients with psychiatric illness/social situations that would limit compliance with study requirements

My white blood cell count is high, but it can be lowered for treatment.

Patients who are receiving any other investigational agents

See 11 more

Treatment Details

Interventions

Liposome-encapsulated Daunorubicin-Cytarabine (Anti-tumor antibiotic, Anti-metabolites)
Pomalidomide (Immunomodulatory Agent)

Trial OverviewThe trial is testing the addition of Pomalidomide—an immunomodulatory drug—to standard chemotherapy (Daunorubicin and Cytarabine Liposome) in patients with AML that has characteristics similar to myelodysplastic syndrome. The study aims to see if this combination improves outcomes compared to the usual treatment alone.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (daunorubicin and cytarabine liposome, pomalidomide)Experimental Treatment4 Interventions

INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 and then pomalidomide PO QD beginning between days 21-30 for 14 days in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial.

Group II: Arm B (daunorubicin and cytarabine liposome)Active Control3 Interventions

INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial.