Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00134004 |
Recruitment Status :
Completed
First Posted : August 24, 2005
Results First Posted : August 24, 2015
Last Update Posted : October 6, 2015
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | August 22, 2005 | |||
First Posted Date ICMJE | August 24, 2005 | |||
Results First Submitted Date ICMJE | June 26, 2015 | |||
Results First Posted Date ICMJE | August 24, 2015 | |||
Last Update Posted Date | October 6, 2015 | |||
Study Start Date ICMJE | October 2004 | |||
Actual Primary Completion Date | January 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
|
|||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer | |||
Official Title ICMJE | A Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Bone Marrow for Patients With Hematologic Malignancies | |||
Brief Summary | RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and radiation therapy before a donor bone marrow transplant helps stop the growth of cancer cells. Giving chemotherapy or radiation therapy before or after transplant also stops the patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem cells may replace the patient's immune system cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer. |
|||
Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to risk of relapse (standard [defined as ≤ 30% risk] vs high [defined as ≥ 70% risk]).
Treatment continues in the absence of disease progression. After completion of study transplantation, patients are followed on days 30, 60, 100, and 180; at 1 year; and then annually for 4 additional years. PROJECTED ACCRUAL: A total of 75-100 patients will be accrued for this study within 3-4 years. |
|||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE |
|
|||
Intervention ICMJE |
|
|||
Study Arms ICMJE | Experimental: Mini-haplo Transplant
Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
Interventions:
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
210 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | January 2015 | |||
Actual Primary Completion Date | January 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 6 Months to 74 Years (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00134004 | |||
Other Study ID Numbers ICMJE | J0457 CDR0000440990 P01CA015396 ( U.S. NIH Grant/Contract ) P30CA006973 ( U.S. NIH Grant/Contract ) JHOC-J0457 ( Other Identifier: Johns Hopkins SKCCC ) JHOC-04072704 |
|||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||
Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
|
|||
PRS Account | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||
Verification Date | September 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |