NCT02756572

Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms

A Feasibility Study of "Early" Allogeneic Hematopoietic Cell Transplantation for Relapsed or Refractory High-Grade Myeloid Neoplasms

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies how well early stem cell transplantation works in treating patients with high-grade myeloid neoplasms that has come back after a period of improvement or does not respond to treatment. Drugs used in chemotherapy, such as filgrastim, cladribine, cytarabine and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a donor peripheral blood cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Early stem cell transplantation may result in more successful treatment for patients with high-grade myeloid neoplasms.

Detailed description

OUTLINE: RE-INDUCTION CHEMOTHERAPY: Patients receive filgrastim subcutaneously (SC) on days 0-5, mitoxantrone hydrochloride intravenously (IV) over 60 minutes on days 1-3, cladribine IV over 2 hours on days 1-5, and cytarabine IV over 2 hours on days 1-5. CONDITIONING REGIMEN: Beginning 14-60 days after re-induction chemotherapy, patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2, melphalan IV on days -3 to -2, cyclosporine orally (PO) twice daily (BID) starting on day -3. Sirolimus PO BID starting on day -3 will be given to patients who have matched unrelated donors or mismatched unrelated donors. Patients \>55 years or with significant co-morbidities will only receive melphalan IV on day -2 and will also receive total body irradiation (TBI) on day -1 or day 0. EARLY TRANSPLANT: Patients undergo allogeneic HCT after conditioning regimen on day 0. GVHD PROPHYLAXIS: Patients with matched donors will receive mycophenolate mofetil PO three times daily (TID) on days 0-30, then twice a day (BID) until day 40; and cyclosporine PO BID on days -3 to 96, with a taper until day 150. Patients with matched unrelated donors also receive sirolimus PO BID on days -3 to 150, with a taper until day 180. Patients with mismatched unrelated donors will receive mycophenolate mofetil PO TID on days 0-30, then BID until day 100, with a taper until day 150; cyclosporine PO BID on days -3 to 150, then taper until day 180; and sirolimus BID PO days -3 to 180, then a taper until day 365. After completion of study treatment, patients are followed up periodically.

Conditions

• Blasts 10 Percent or More of Bone Marrow Nucleated Cells
• Chronic Myelomonocytic Leukemia-2
• High Grade Malignant Neoplasm
• Myelodysplastic Syndrome
• Myelodysplastic Syndrome With Excess Blasts-2
• Myeloid Neoplasm
• Previously Treated Myelodysplastic Syndrome
• Recurrent Acute Myeloid Leukemia
• Refractory Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Cladribine	Given IV
DRUG	Cyclosporine	Given PO
DRUG	Cytarabine	Given IV
BIOLOGICAL	Filgrastim	Given SC
DRUG	Fludarabine Phosphate
PROCEDURE	Allogeneic Hematopoietic Stem Cell Transplantation	Undergo allogeneic hematopoietic stem cell transplantation
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Melphalan	Given IV
DRUG	Mitoxantrone Hydrochloride	Given IV
DRUG	Mycophenolate Mofetil	Given PO
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Sirolimus	Given PO
RADIATION	Total-Body Irradiation	Undergo TBI
DRUG	Melphalan Hydrochloride	Given IV

Timeline

• Start date: 2016-09-22
• Primary completion: 2020-03-01
• Completion: 2020-07-01
• First posted: 2016-04-29
• Last updated: 2021-11-08
• Results posted: 2021-03-22

Locations

1 site across 1 country: United States