Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT01028716|
Recruitment Status : Recruiting
First Posted : December 9, 2009
Last Update Posted : January 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Biphenotypic Leukemia Acute Erythroid Leukemia in Remission Acute Leukemia in Remission Acute Lymphoblastic Leukemia in Remission Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Acute Myeloid Leukemia in Remission Acute Myeloid Leukemia With FLT3/ITD Mutation Acute Myeloid Leukemia With Inv(3) (q21.3;q26.2); GATA2, MECOM Acute Myeloid Leukemia With Multilineage Dysplasia Acute Myeloid Leukemia With t(6;9) (p23;q34.1); DEK-NUP214 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) B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 Burkitt Lymphoma Childhood Acute Lymphoblastic Leukemia in Complete Remission DS Stage II Plasma Cell Myeloma DS Stage III Plasma Cell Myeloma Myelodysplastic Syndrome Recurrent Anaplastic Large Cell Lymphoma Blasts Under 5 Percent of Bone Marrow Nucleated Cells 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 T Lymphoblastic Lymphoma Hematopoietic Cell Transplant Recipient||Drug: Cyclophosphamide Biological: Filgrastim Drug: Fludarabine Phosphate Procedure: Laboratory Biomarker Analysis Drug: Mycophenolate Mofetil Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Procedure: Peripheral Blood Stem Cell Transplantation Drug: Tacrolimus Radiation: Total-Body Irradiation Drug: Fludarabine||Phase 2|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Phase II Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source|
|Actual Study Start Date :||February 8, 2010|
|Estimated Primary Completion Date :||January 4, 2023|
|Estimated Study Completion Date :||January 4, 2023|
Experimental: Treatment (nonmyeloablative HCT, TBI)
Patients receive fludarabine 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 PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is >= 1,000/mm^3 for three consecutive days.
Drug: Fludarabine Phosphate
Procedure: Laboratory Biomarker Analysis
Drug: Mycophenolate Mofetil
Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Peripheral Blood Stem Cell Transplantation
Given IV or PO
Radiation: Total-Body Irradiation
Undergo total-body irradiation (TBI)
- Cumulative incidence of non-relapse mortality, defined as death without evidence of disease progression [ Time Frame: Up to 1 year ]
- Incidence of chronic graft versus host disease [ Time Frame: Up to 1 year post-transplant ]Scored according to the National Cancer Institute criteria. The time to onset of limited and extensive chronic graft versus host disease will be recorded.
- Incidence of grades III/IV acute graft versus host disease [ Time Frame: At day 84 ]Grading determined by organ system stages. Grade III/IV acute graft versus host disease is defined as skin: stage IV, liver: stages II-IV, and/or gastrointestinal tract: stages II-IV.
- Relapse of malignancy after transplantation [ Time Frame: Up to 7 years ]Defined by either morphological or cytogenetic evidence of acute leukemia consistent with pre-transplant features, or radiologic evidence of lymphoma progression. When in doubt, the diagnosis of recurrent or progressive lymphoma should be documented by tissue biopsy.
- Donor cell engraftment [ Time Frame: Up to day 84 post-transplant ]Donor chimerism in the T-cell (CD3-positive) and granulocyte (CD33-positive) fractions of sorted peripheral blood greater or equal to 50%.
- Infections [ Time Frame: Up to 7 years ]Reported by anatomic site, date of onset, organism and resolution, if any.
- Neutrophil recovery [ Time Frame: Up to day 84 post-transplant ]Achievement of an absolute neutrophil count greater or equal to 500/mm^3 for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil recovery.
- Platelet recovery [ Time Frame: Up to day 84 post-transplant ]The first day of a sustained platelet count > 20,000/mm^3 with no platelet transfusions in the preceding seven days.
- Primary graft failure [ Time Frame: At day 84 ]Defined as < 5% donor CD3 chimerism. Chimerism will be measured by short tandem repeat-polymerase chain reaction on peripheral blood sorted into CD3 and CD33 cell fractions.
- Progression-free survival [ Time Frame: Time interval to relapse/recurrence, to death or to last follow-up, assessed for up to 7 years ]Defined as the minimum time interval to relapse/recurrence, to death or to last follow-up.
- Secondary graft failure [ Time Frame: Up to day 84 post-transplant ]Initial recovery followed by neutropenia with < 5% donor chimerism. If no chimerism assays were performed and absolute neutrophil count is less than 500/mm^3, then it will be counted as a secondary graft failure.
- Toxicity of treatment regimen [ Time Frame: Up to day 90 ]Assessed by Common Terminology Criteria for Adverse Events version 3.0. The incidence of all adverse events greater or equal to grade 3 will be determined.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028716
|Contact: Rachel B. Salitfirstname.lastname@example.org|
|United States, Washington|
|VA Puget Sound Health Care System||Withdrawn|
|Seattle, Washington, United States, 98101|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Rachel B. Salit 206-667-1317 email@example.com|
|Principal Investigator: Rachel B. Salit|
|Principal Investigator:||Rachel B. Salit||Fred Hutch/University of Washington Cancer Consortium|