Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Official Title
A Phase I Trial Of Total Body Irradiation, Cyclophosphamide Dose-Adjustment Based On Its Metabolism, And Hematopoietic Stem Cell Transplantation For Patients With Hematological Malignancy
Acronym
Not provided
Organization
Fred Hutchinson Cancer CenterOTHER
Status Module
Record Verification Date
Sep 2010
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2003
Primary Completion Date
Not provided
Completion Date
Jul 2004Actual
First Submitted Date
Jun 5, 2003
First Submission Date that Met QC Criteria
Jun 5, 2003
First Posted Date
Jun 6, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 20, 2010
Last Update Posted Date
Sep 21, 2010Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Fred Hutchinson Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Adjusting the dose of drugs used in chemotherapy such as cyclophosphamide may decrease side effects while stopping cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells.
PURPOSE: Phase I trial to study the effect on the body of dose-adjusted cyclophosphamide combined with total-body irradiation and donor stem cell transplantation in treating patients who have hematologic cancer.
Detailed Description
OBJECTIVES:
Determine a safe and reproducible method of adjusting the dose of cyclophosphamide based on its metabolism when given in combination with total body irradiation and hematopoietic stem cell transplantation in patients with hematologic malignancy.
OUTLINE:
Preparative regimen: Patients undergo total body irradiation twice daily on days -6 to -4. Patients then receive dose-adjusted (based on metabolism) cyclophosphamide IV over 1 hour on days -3 and -2.
Hematopoietic stem cell (HSC) infusion: Patients undergo allogeneic HSC transplantation on day 0.
Patients receive graft-versus-host disease prophylaxis, CNS prophylaxis, and testicular irradiation as per institutional standard practices.
Patients are followed daily until day 80 after transplantation and then regularly thereafter for survival.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Conditions Module
Conditions
Leukemia
Lymphoma
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Keywords
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
cyclophosphamide
Drug
allogeneic bone marrow transplantation
Procedure
peripheral blood stem cell transplantation
Procedure
radiation therapy
Radiation
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of hematological malignancy, including any of the following:
Chronic myeloid leukemia
Acute myeloid leukemia
Acute lymphocytic leukemia
Myelodysplastic syndromes
Lymphoma
Unlikely to respond to conventional treatment and would benefit from hematopoietic stem cell transplantation
No bulky tumor mass requiring additional involved field radiotherapy
No large body burden of tumor cells requiring cytoreductive chemotherapy before total body irraditation and cyclophosphamide
Undergoing conditioning for transplantation at the University of Washington Medical Center
Availability of 1 of the following types of allogeneic donors:
HLA-identical family members
Unrelated donors
Allele match (match grade 1)
One allele mismatch for A, B, C, DRB1 or DQB1 (match grades 2.1 or 2.2)
PATIENT CHARACTERISTICS:
Age
18 to 65
Performance status
Not specified
Life expectancy
Not severely limited by diseases other than malignancy
Not moribund
Hematopoietic
Not specified
Hepatic
Bilirubin no greater than 1.2 mg/dL
No cirrhosis
No hepatic fibrosis with bridging
Renal
Creatinine no greater than 1.2 mg/dL
Cardiovascular
No coronary artery disease
No congestive heart failure requiring therapy
Pulmonary
Oxygen saturation at least 93% (on room air)
Other
Not pregnant or nursing
Fertile patients must use effective contraception
HIV negative
No concurrent infection requiring systemic antibiotic or antifungal therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior hematopoietic stem cell transplantation
Chemotherapy
See Disease Characteristics
Endocrine therapy
Not specified
Radiotherapy
See Disease Characteristics
No prior radiotherapy to the liver or adjacent organs
Surgery
Not specified
Other
No concurrent aspirin or nonsteroidal anti-inflammatory medications such as ibuprofen (e.g., Motrin® or Advil®)
No other concurrent phase I study enrollment
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
George B. McDonald, MD
Fred Hutchinson Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Fred Hutchinson Cancer Research Center
Seattle
Washington
98109-1024
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
stage III adult lymphoblastic lymphoma
stage IV adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV adult Burkitt lymphoma
recurrent adult acute myeloid leukemia
untreated adult acute myeloid leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
recurrent mycosis fungoides/Sezary syndrome
secondary acute myeloid leukemia
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III mantle cell lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV mantle cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma