Clofarabine Pre-conditioning Followed by Stem Cell Transplant for Non-remission AML

• Status: Recruiting
• Trial end date: 2026-06-03
• Target enrollment: 0
• Participant gender: All

Summary

The Investigators would like to study the incidence of complete remission (CR) at day +30 after Clofarabine followed by haploidentical transplant. The conditioning regimen used is Fludarabine, Busulfan (2 doses) or cyclophosphamide (2 doses) and Total Body Irradiation (TBI) with post transplant cyclophosphamide for patients with Acute Myeloid Leukemia (AML) who are not in remission prior to considering allogeneic transplant with haploidentical donors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Busulfan; Clofarabine; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Lenograstim; Mycophenolic Acid; Sargramostim; Tacrolimus; Vidarabine

Criteria

Inclusion Criteria:

1. Diagnostic criteria of AML, induction failure without having achieved remission after at least 2 attempts at induction chemotherapy, or relapsed after any complete remission (CR).

2. 18 to 75 years of age.

3. Planned or scheduled to receive an allogeneic HSCT from haploidentical related donors, matched and mismatched unrelated donors.

4. All organ function testing should be done within 28 days of study registration.

• Performance status: Karnofsky ≥ 70% (Appendix A).

• Cardiac: LVEF ≥ 50% by MUGA or echocardiogram.

• Pulmonary: FEV1 and FVC ≥ 50% predicted, DLCO (corrected for hemoglobin) ≥ 50% of predicted.

• Renal: Creatinine clearance (CrCl) ≥ 60 mL/min/1.73 m2

• Hepatic: Serum bilirubin ≤1.5 x upper limit of normal (ULN); (AST)/(ALT) ≤ 2.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN.

5. Both men and women need to use an approved method of birth control and/or abstinence due to unknown risks to the fetus.

Exclusion Criteria:

1. Acute promyelocytic leukemia (APL)

2. Known history of non-compliance with medication regimens, scheduled clinic visits, or self-care.

3. In the opinion of the investigator, no appropriate caregivers identified.

4. HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive

5. Active Hepatitis B and Hepatitis C.

6. In the opinion of the physician investigator, uncontrolled medical or psychiatric disorders.

7. Uncontrolled infections requiring treatment within 14 days of registration.

8. Active central nervous system (CNS) leukemia.

9. Cord blood transplant excluded.

10. Prior allogeneic HSCT within last 6 months.

11. Patients with >= grade 2 acute GVHD.

12. Patients with >=moderate chronic GVHD.

13. Pregnant or Breastfeeding. Women of child bearing potential (WCBP) are required to have a negative serum or urine pregnancy test prior to initiation of conditioning regimen.

14. Haploidentical related donors who are positive for DSA ≥ 5000 MFI by solid phase microarray method (Luminex).