Clinical Trials Logo

Clinical Trial Summary

This phase II trial studies how well giving treosulfan together with fludarabine phosphate and total-body irradiation (TBI) works in treating patients with hematological cancer who are undergoing umbilical cord blood transplant (UCBT). Giving chemotherapy, such as treosulfan and fludarabine phosphate, and TBI before a donor UCBT helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related or unrelated donor, that do not exactly match the patient's blood, are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CsA) and mycophenolate mofetil (MMF) after the transplant may stop this from happening.


Clinical Trial Description

PRIMARY OBJECTIVES: I. Graft failure/rejection and secondary graft failure. II. Day -200 non-relapse mortality. SECONDARY OBJECTIVES: I. Platelet engraftment by six months. II. Grade II-IV and III-IV acute graft-versus-host disease (GVHD) at day 100 and one year. III. Chronic GVHD. IV. Clinically significant infections. V. Overall survival. VI. Relapse or disease progression. VII. Immune reconstitution (Fred Hutchinson Cancer Research Center [FHCRC] only). VIII. Emergence of a dominant unit (FHCRC only). OUTLINE: Patients are assigned to 1 of 2 arms. ARM I (low risk for graft failure): Patients receive a conditioning regimen comprising fludarabine phosphate intravenously (IV) over 1 hour once daily (QD) on days -6 to -2 and treosulfan IV over 120 minutes on days - 6 to -4. Patients undergo TBI on day -1. Patients then undergo donor UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour or orally (PO) 2-3 times daily on days -3 to 100, followed by a taper in the absence of GVHD. Patients also receive mycophenolate mofetil IV 3 times daily on days 0 to 40, followed by a taper in the absence of GVHD. ARM II (high risk for graft failure): Patients receive a conditioning regimen, TBI, donor UCBT, GVHD prophylaxis, and mycophenolate mofetil as in Arm I. After completion of the study treatment, patients are followed up at 6 months and 1 and 2 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00796068
Study type Interventional
Source Fred Hutchinson Cancer Center
Contact
Status Completed
Phase Phase 2
Start date February 24, 2009
Completion date December 14, 2021

See also
  Status Clinical Trial Phase
Completed NCT02626715 - Reduced-Intensity Conditioning (RIC) and Myeloablative Conditioning (MAC) for HSCT in AML/MDS Phase 2
Recruiting NCT02905552 - Myelodysplasic Syndromes and Risk Factors for Infection N/A
Completed NCT01772953 - Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT Phase 2
Suspended NCT01211691 - Study of KB004 in Subjects With Hematologic Malignancies (Myelodysplastic Syndrome, MDS, Myelofibrosis, MF) Phase 1/Phase 2
Active, not recruiting NCT06294275 - A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects Phase 1
Completed NCT00533416 - Safety of ON 01910.Na in Patients With Myelodysplasia Phase 1
Active, not recruiting NCT04401748 - Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome Phase 3
Recruiting NCT04608110 - A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome Phase 1
Recruiting NCT03613532 - Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN Phase 1
Withdrawn NCT03486353 - A Study of FF-10501-01 in Combination With Azacitidine in Patients With Myelodysplastic Syndrome Phase 2
Terminated NCT02259348 - Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation Phase 2
Terminated NCT01459159 - Study of (Telintra®) in Non-Del(5q) Myelodysplastic Syndrome Phase 2
Terminated NCT01422486 - Phase 2 Study of Telintra® in Deletion 5q Myelodysplastic Syndrome Phase 2
Terminated NCT00542828 - Rabbit Anti-thymocyte Globulin in the Treatment of Patients With Low to Intermediate-1 Risk Myelodysplastic Syndrome Phase 2
Completed NCT01685619 - AML-MDS Novel Prognostic Tests Clinical Study
Recruiting NCT01861093 - Safety Study of Cord Blood Units for Stem Cell Transplants Phase 2
Unknown status NCT01983761 - Study of ASC-101 in Patients With Hematologic Malignancies Who Receive Dual-cord Umbilical Cord Blood Transplantation Phase 1/Phase 2
Recruiting NCT01758042 - Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders N/A
Completed NCT01338337 - Study of Vidaza (Azacitidine) Versus Support Treatment in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) Without the 5q Deletion and Transfusion Dependent Anaemia Phase 2
Completed NCT01221857 - Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies Phase 1/Phase 2