Clinical trial · Interventional
Clofarabine Pre-conditioning Followed by Stem Cell Transplant for Non-remission AML
Clofarabine Pre-conditioning Followed by Hematopoietic Stem Cell Transplant With Post-Transplant Cyclophosphamide for Non-remission Acute Myeloid Leukemia
NCT04002115CI-TRIAL-00069604terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): terminated due to low accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
| Cellcept | Drug | — | UNRESOLVED |
| Clofarabine | Drug | Clofarabine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Granulocyte Colony-Stimulating Factor | Drug | — | UNRESOLVED |
| Tacrolimus | Drug | — | UNRESOLVED |
| Total Body Irradiation (TBI) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Clofarabine 30 mg/m^2
- description
- Day -14 through Day -10 Clofarabine 30 mg/m\^2, Day - 9 Day of rest, Day - 8 Day of rest, Day - 7 Day of rest, Day - 6 Fludarabine 40 mg/m\^2 IV and Busulfan 3.2 mg/kg IV (Regimen A, Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B), Day - 5 Fludarabine 40 mg/m\^2 IV and Busulfan 3.2 mg/kg IV (Regimen A, Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B), Day - 4 Fludarabine 40 mg/m\^2 IV(Regimen A, Fludarabine 24 mg/m\^2 IV for Regimen B), Day - 3 Fludarabine 40 mg/m\^2 IV(Regimen A, Fludarabine 24 mg/m\^2 IV for Regimen B), Day - 2 Day of Rest, Day -1 Total Body Irradiation 200 cGys, Day 0 stem cell transplant infusion, Day +1 Day of rest, Day +2 Day of rest, Day +3 Cyclophosphamide 50 mg/kg IV, Day +4 Cyclophosphamide 50 mg/kg IV, Day +5 Start G-CSF, Tacrolimus, and MMF.
- interventionNames
- Drug: Clofarabine
- Drug: Fludarabine
- Drug: Busulfan
- Procedure: Total Body Irradiation (TBI)
- Drug: Cyclophosphamide
- Drug: Granulocyte Colony-Stimulating Factor
- Drug: Tacrolimus
- Drug: Cellcept
Primary outcomes (1)
- measure
- Complete Remission (CR) Rate at Day 30 Post HSCT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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 orepatitis positive serology including HBsAg, hepatitis B core antibody, and hepatitis C antibody. Hepatitis B surface antibody positive due to vaccination or natural immunity are permitted. 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). 15. Any patient with steroid dose more than 10 mg/day within a week of registration . 16. Autoimmune disorder requiring any active immunosuppression therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.