Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Sidney Kimmel Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT00134004

First received: August 22, 2005

Last updated: September 2, 2015

Last verified: September 2015

History of Changes

Results First Received: June 26, 2015

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes
Interventions:	Drug: cyclophosphamide Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Radiation: radiation therapy

Participant Flow

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Recruitment Details

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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Mini-haplo BMT	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.

Participant Flow: Overall Study

	Mini-haplo BMT
STARTED	210
COMPLETED	210
NOT COMPLETED	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Mini-haplo BMT	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.

Baseline Measures

	Mini-haplo BMT
Number of Participants [units: participants]	210
Age [units: years] Mean (Full Range)	52 (1 to 73)
Gender [units: participants]
Female	61
Male	149
Region of Enrollment [units: participants]
United States	210

Outcome Measures

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1. Primary:

Transplant-related Mortality [ Time Frame: Cumulative incidence for the entire study, up to 11 years ]

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2. Primary:

Relapse Rate [ Time Frame: Cumulative incidence for the entire study, up to 11 years ]

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3. Primary:

Progression-free Survival [ Time Frame: 2 years ]

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4. Secondary:

Graft Failure Rate [ Time Frame: Cumulative incidence for the entire study, up to 11 years ]

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5. Secondary:

Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation [ Time Frame: 1 year ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Dr. Ephraim Fuchs
Organization: Johns Hopkins University
phone: 410-419-6479
e-mail: fuchsep@jhmi.edu

Responsible Party:	Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00134004 History of Changes
Other Study ID Numbers:	J0457 CDR0000440990 P01CA015396 ( US NIH Grant/Contract Award Number ) P30CA006973 ( US NIH Grant/Contract Award Number ) JHOC-J0457 ( Other Identifier: Johns Hopkins SKCCC ) JHOC-04072704
Study First Received:	August 22, 2005
Results First Received:	June 26, 2015
Last Updated:	September 2, 2015
Health Authority:	United States: Food and Drug Administration

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