Clinical Trials Logo

Clinical Trial Summary

This phase II trial studies how well donor peripheral blood stem cell (PBSC) transplant works in treating patients with hematologic malignancies. Cyclophosphamide when added to tacrolimus and mycophenolate mofetil is safe and effective in preventing severe graft-versus-host disease (GVHD) in most patients with hematologic malignancies undergoing transplantation of bone marrow from half-matched (haploidentical) donors. This approach has extended the transplant option to patients who do not have matched related or unrelated donors, especially for patients from ethnic minority groups. The graft contains cells of the donor's immune system which potentially can recognize and destroy the patient's cancer cells (graft-versus-tumor effect). Rejection of the donor's cells by the patient's own immune system is prevented by giving low doses of chemotherapy (fludarabine phosphate and cyclophosphamide) and total-body irradiation before transplant. Patients can experience low blood cell counts after transplant. Using stem cells and immune cells collected from the donor's circulating blood may result in quicker recovery of blood counts and may be more effective in treating the patient's disease than using bone marrow.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To demonstrate that use of PBSC in place of marrow as the source of lymphocytes and stem cells for nonmyeloablative transplants from related, haploidentical donors will not result in unacceptable rates of high-grade acute or chronic GVHD, non-relapse mortality or relapse compared to historical data on nonmyeloablative transplants from unrelated donors. SECONDARY OBJECTIVES: I. Estimates of the rates of neutrophil and platelet recovery, number of red blood cell (RBC) and platelet transfusions, incidences of graft failure, transplant-related toxicities, disease-free survival and overall survival. OUTLINE: Patients receive fludarabine intravenously (IV) over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Patients undergo donor peripheral blood stem cell transplant on day 0. Patients then receive tacrolimus IV once daily or orally (PO) twice daily (BID) on days 5-180 (may be continued if active GVHD is present), mycophenolate mofetil IV or PO thrice daily (TID) on days 5-35 (may be continued if GVHD present), and filgrastim IV beginning on day 5 until the absolute neutrophil count (ANC) is >= 1,000/mm^3 for three consecutive days. Treatment continues in the absence of disease progression or unacceptable toxicity. ;


Study Design


Related Conditions & MeSH terms

  • Acute Biphenotypic Leukemia
  • Acute Erythroid Leukemia in Remission
  • Acute Leukemia in Remission
  • Acute Lymphoblastic Leukemia in Remission
  • Acute Myeloid Leukemia in Remission
  • Acute Myeloid Leukemia With FLT3/ITD Mutation
  • Acute Myeloid Leukemia With Multilineage Dysplasia
  • Acute Undifferentiated Leukemia
  • Adult Acute Lymphoblastic Leukemia in Complete Remission
  • B Acute Lymphoblastic Leukemia With T(1;19)(Q23;P13.3); E2A-PBX1 (TCF3-PBX1)
  • Blasts Under 5 Percent of Bone Marrow Nucleated Cells
  • Burkitt Lymphoma
  • Childhood Acute Lymphoblastic Leukemia in Complete Remission
  • DS Stage II Plasma Cell Myeloma
  • DS Stage III Plasma Cell Myeloma
  • Hematologic Neoplasms
  • Hematopoietic Cell Transplant Recipient
  • Leukemia
  • Leukemia, Biphenotypic, Acute
  • Leukemia, Erythroblastic, Acute
  • Leukemia, Lymphoid
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Lymphoma
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Mantle-Cell
  • Multiple Myeloma
  • Myelodysplastic Syndrome
  • Myelodysplastic Syndromes
  • Neoplasms, Plasma Cell
  • Ph+ ALL
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Preleukemia
  • Recurrence
  • Recurrent Anaplastic Large Cell Lymphoma
  • Recurrent Follicular Lymphoma
  • Recurrent Hodgkin Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Plasma Cell Myeloma
  • Refractory Plasma Cell Myeloma
  • Secondary Acute Myeloid Leukemia
  • Syndrome
  • T Lymphoblastic Lymphoma

NCT number NCT01028716
Study type Interventional
Source Fred Hutchinson Cancer Center
Contact
Status Terminated
Phase Phase 2
Start date May 19, 2010
Completion date October 7, 2021

See also
  Status Clinical Trial Phase
Completed NCT04022785 - PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Phase 1
Completed NCT01200355 - Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome Phase 4
Active, not recruiting NCT02530463 - Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome Phase 2
Completed NCT02057185 - Occupational Status and Hematological Disease
Completed NCT01682226 - Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies Phase 2
Completed NCT02485535 - Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant Phase 1
Completed NCT03941769 - 2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/II Phase 1/Phase 2
Completed NCT00001637 - Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults Phase 2
Recruiting NCT06195891 - Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome Phase 1
Active, not recruiting NCT04188678 - Resiliency in Older Adults Undergoing Bone Marrow Transplant N/A
Completed NCT00987480 - Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine Phase 2
Recruiting NCT02356159 - Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation Phase 1/Phase 2
Completed NCT04666025 - SARS-CoV-2 Donor-Recipient Immunity Transfer
Completed NCT02756572 - Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms Phase 2
Terminated NCT02877082 - Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients Phase 2
Completed NCT02543879 - Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies Phase 1
Completed NCT02262312 - Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome Phase 0
Completed NCT02188290 - Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation N/A
Recruiting NCT02330692 - Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and Relapse in Myelodysplastic Syndrome
Completed NCT01684150 - A Phase 1, Open-Label, Dose-Escalation & Expanded Cohort, Continuous IV Infusion, Multi-center Study of the Safety, Tolerability,PK & PD of EPZ-5676 in Treatment Relapsed/Refractory Patients With Leukemias Involving Phase 1