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DNA Methyltransferase Inhibitor

Guadecitabine + Donor Lymphocytes for Leukemia Relapse After Transplant

Phase 2

Waitlist Available

Led By Betul Oran, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be able to start the drug therapy between 42 to 100 days following allogeneic SCT; No more than 1 prior allogeneic SCT; Post-transplant bone marrow consistent with complete remission with no evidence of minimal residual disease by flow-cytometry or cytogenetics or molecular testing; Adequate engraftment within 14 days prior to starting study drug: absolute neutrophil count (ANC) >= 1.0 x 10^9/L without daily use of myeloid growth factor; and, platelet >= 50 x 10^9/L without platelet transfusion within 1 week; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; Serum creatinine =< 1.5 mg/dL or creatinine clearance greater or equal than 40 cc/min as defined by the Cockcroft-Gault equation; Serum bilirubin =< 1.5 x upper limit of normal (ULN); Aspartate transaminase (AST) or alanine transaminase (ALT) =< 2.5 x ULN; Alkaline phosphatase =< 2.5 x upper limit (UL); No active bleeding; No uncontrolled graft versus host disease (GVHD); No clinical evidence of life-threatening infection; Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent; Human immunodeficiency virus (HIV) negative and hepatitis B surface antigen (HBs-Ag) negative; Negative serum or urine pregnancy test for women with reproductive potential; the only subjects who will be exempt from this criterion are postmenopausal women (defined as women who have been amenorrheic for > 12 months) or subjects who have been surgically sterilized or otherwise proven sterile

Diagnosis of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) according to WHO classification that underwent first allogeneic hematopoietic cell transplant (HSCT) with either peripheral blood or bone marrow as the source of the hematopoietic stem cells

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year

Awards & highlights

Study Summary

This trial tests if guadecitabine can help patients with leukemia & myelodysplasia who relapsed after a stem cell transplant. It could stop cancer cells & protect against graft-vs-host disease, & donor lymphocyte infusions may help.

Who is the study for?

This trial is for patients with acute myeloid leukemia or myelodysplastic syndrome that's come back after a stem cell transplant. Participants must have a good match with their donor, be in specific stages of disease recovery or relapse, and have stable organ function without severe infections or active graft versus host disease. They can't join if they've had certain heart issues recently, uncontrolled infections, multiple transplants, or are HIV positive.Check my eligibility

What is being tested?

The study tests guadecitabine's effectiveness in treating cancer recurrence post-transplant. It examines whether the drug can prevent growth of cancer cells and enhance the immune response against them when followed by an infusion of donor white blood cells (donor lymphocyte infusion).See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site, changes in blood counts leading to increased infection risk or bleeding tendencies, liver enzyme alterations suggesting liver stress, and possible worsening of graft versus host disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have AML or MDS and had my first stem cell transplant using cells from blood or bone marrow.

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My donor and I have a maximum of one mismatch in our HLA markers.

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My cancer has returned or is still present after a stem cell transplant, even though it looks like I'm in remission.

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I am in complete remission from AML or MDS after a stem cell transplant, with no signs of the disease.

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I have MDS with changes in my bone marrow or AML with a bone marrow blast count of 5% or more.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete response (CR) rate (Cohort 1 and 2)

Relapse free survival (RFS) (Cohort 3)

Secondary outcome measures

Disease-free survival time (DFS)

Duration of remission

Bone Transplantation

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (guadecitabine, DLI)Experimental Treatment3 Interventions

Patients receive guadecitabine SC QD on days 1-5. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive DLI IV over 10-30 minutes on day 6 of cycles 2, 4, and 6 in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Donor Lymphocytes

2008

Completed Phase 2

~10

Guadecitabine

2014

Completed Phase 3

~570