Fludarabine Phosphate, Low-Dose Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer
NCT ID: NCT00005799
Last Updated: 2019-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
1999-11-30
Brief Summary
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Detailed Description
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I. To determine whether stable allogeneic engraftment from unrelated hematopoietic stem cell donors can be safely established using a non-myeloablative conditioning regimen in patients with hematologic malignancies and renal cell carcinoma.
SECONDARY OBJECTIVES:
I. To evaluate whether donor lymphocyte infusion (DLI) can be safely used in patients with mixed or full donor chimerism to eliminate persistent or progressive disease.
OUTLINE:
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2. Patients also undergo low-dose total-body irradiation (TBI) on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) or bone marrow transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) on days -3 to 100 with taper to day 177 and mycophenolate mofetil PO BID on days 0-40 with taper to day 96. Patients with mixed chimerism, persistent or progressive disease, and no evidence of graft-versus-host disease and who have been off immunosuppression for at least 2 weeks undergo DLI over 30 minutes. DLI may be repeated every 65 days for up to 3 doses.
After completion of study treatment, patients are follow-up periodically for 5 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (chemotherapy, TBI, HSCT)
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0.
TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 100 with taper to day 177 and mycophenolate mofetil PO BID on days 0-40 with taper to day 96. Patients with mixed chimerism, persistent or progressive disease, and no evidence of graft-versus-host disease and who have been off immunosuppression for at least 2 weeks undergo DLI over 30 minutes. DLI may be repeated every 65 days for up to 3 doses.
fludarabine phosphate
Given IV
total-body irradiation
Undergo low-dose TBI
nonmyeloablative allogeneic hematopoietic stem cell transplantation
Undergo nonmyeloablative HSCT
allogeneic bone marrow transplantation
Undergo nonmyeloablative allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
Undergo nonmyeloablative allogeneic PBSC transplantation
therapeutic allogeneic lymphocytes
Undergo DLI
cyclosporine
Given PO
mycophenolate mofetil
Given PO
pharmacological study
Correlative studies
laboratory biomarker analysis
Correlative studies
Interventions
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fludarabine phosphate
Given IV
total-body irradiation
Undergo low-dose TBI
nonmyeloablative allogeneic hematopoietic stem cell transplantation
Undergo nonmyeloablative HSCT
allogeneic bone marrow transplantation
Undergo nonmyeloablative allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
Undergo nonmyeloablative allogeneic PBSC transplantation
therapeutic allogeneic lymphocytes
Undergo DLI
cyclosporine
Given PO
mycophenolate mofetil
Given PO
pharmacological study
Correlative studies
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with metastatic renal cell carcinoma with the histologic subtypes of clear cell, papillary and medullary may be accepted regardless of age
* The following diseases will be permitted although other diagnoses can be considered if approved by PCC or the participating institution's patient review committees and the principal investigator
* Non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), Hodgkin lymphoma (HL) - must have received and failed frontline therapy
* Multiple myeloma - must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative HSCT is permitted
* Acute myeloid leukemia (AML)/acute lymphoblastic leukemia (ALL) - must be in complete remission and have received cytotoxic chemotherapy at some stage before transplant; patients with molecular or early relapse will be accepted providing a donor is available; patients with persistent or refractory disease will be considered on a case by case basis and transplants must be approved by the institution's patient review committees
* Chronic myelogenous leukemia (CML) - patients will be accepted in chronic phase or accelerated phase; patients who have received prior autografts after high dose therapy or have undergone intensive chemotherapy for either peripheral blood stem cell (PBSC) mobilization or treatment of advanced CML may be enrolled provided they are in complete remission (CR), chronic phase (CP) or accelerated phase (AP)
* Myelodysplastic syndromes (MDS) - all patients with MDS will be eligible for this protocol; however, those patients with MDS and frank AML (\> 30% blasts in bone marrow aspirate by morphology or flow cytometry) will require induction chemotherapy to obtain a complete remission (marrow blasts \< 5%) and remain in complete remission at time of transplant
* Renal cell carcinoma- must have evidence of disease not amenable to surgical cure or metastatic disease by radiological and histological criteria
* DONOR: Human leukocyte antigen (HLA) matched unrelated donor; donors should be matched for HLA -A, -B, -C, -developmentally regulated ribonucleic acid (RNA) binding protein 1(DRB)1 and -class II, DQ beta 1 (DQB) 1; HLA -A and -B loci should be matched at least to the level of resolution; HLA -C, -DRB1, and -DQB1 should be typed at the highest level of resolution available at the time of donor selection; donor must consent to either a bone marrow harvest or PBSC mobilization with filgrastim (G-CSF) arranged through the National Marrow Donor Program (NMDP) or other donor centers
Exclusion Criteria
* Renal cell carcinoma patients with expected survival of less than 6 months
* Bulky disease resulting in severely limited performance status (\< 70%)
* Any vertebral instability
* Any active central nervous system (CNS) involvement with disease
* Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
* Females who are pregnant
* Patients with non-hematological tumors
* Cardiac ejection fraction \< 30%
* Diffusion capacity of the lung for carbon monoxide (DLCO) \< 30% and/or receiving supplementary continuous oxygen
* Significant elevation of bilirubin and transaminases should be discussed at participating institutions' patient review committees in a case by case basis; evidence of synthetic dysfunction or severe cirrhosis will result in patient exclusion
* Karnofsky score \< 50 (except renal cell carcinoma \[RCC\])
* Patients with poorly controlled hypertension on multiple antihypertensives
* Human immunodeficiency virus (HIV) positive patients
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Brenda Sandmaier
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
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City of Hope Medical Center
Duarte, California, United States
Stanford University Hospitals and Clinics
Stanford, California, United States
University of Colorado
Denver, Colorado, United States
Baylor University Medical Center
Dallas, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Universitaet Leipzig
Leipzig, , Germany
Countries
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References
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Cooper JP, Storer BE, Granot N, Gyurkocza B, Sorror ML, Chauncey TR, Shizuru J, Franke GN, Maris MB, Boyer M, Bruno B, Sahebi F, Langston AA, Hari P, Agura ED, Lykke Petersen S, Maziarz RT, Bethge W, Asch J, Gutman JA, Olesen G, Yeager AM, Hubel K, Hogan WJ, Maloney DG, Mielcarek M, Martin PJ, Flowers MED, Georges GE, Woolfrey AE, Deeg JH, Scott BL, McDonald GB, Storb R, Sandmaier BM. Allogeneic hematopoietic cell transplantation with non-myeloablative conditioning for patients with hematologic malignancies: Improved outcomes over two decades. Haematologica. 2021 Jun 1;106(6):1599-1607. doi: 10.3324/haematol.2020.248187.
Other Identifiers
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NCI-2012-00667
Identifier Type: REGISTRY
Identifier Source: secondary_id
1463.00
Identifier Type: OTHER
Identifier Source: secondary_id
1463.00
Identifier Type: -
Identifier Source: org_study_id
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