Cyclophosphamide and Busulfan Followed by Donor Stem Cell Transplant in Treating Patients With Myelofibrosis, Acute Myeloid Leukemia, or Myelodysplastic Syndrome

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions:	Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Childhood Acute Myeloid Leukemia in Remission; Childhood Myelodysplastic Syndromes; de Novo Myelodysplastic Syndromes; Essential Thrombocythemia; Myelodysplastic Syndrome With Isolated Del(5q); Polycythemia Vera; Previously Treated Myelodysplastic Syndromes; Primary Myelofibrosis; Recurrent Adult Acute Myeloid Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Secondary Myelodysplastic Syndromes; Secondary Myelofibrosis; Untreated Adult Acute Myeloid Leukemia; Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Interventions:	Drug: cyclophosphamide; Drug: busulfan; Drug: tacrolimus; Drug: methotrexate; Genetic: cytogenetic analysis; Other: flow cytometry; Other: pharmacological study; Other: pharmacogenomic studies; Procedure: peripheral blood stem cell transplantation; Procedure: allogeneic hematopoietic stem cell transplantation

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Recruitment Details

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Pre-Assignment Details

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Reporting Groups

Description

Treatment (Cyclophosphamide, Busulfan, Transplant)

CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11. cyclophosphamide: Given IV busulfan: Given IV tacrolimus: Given IV or PO methotrexate: Given IV cytogenetic analysis: Correlative studies flow cytometry: Correlative studies pharmacological study: Correlative studies pharmacogenomic studies: Correlative studies peripheral blood stem cell transplantation: Undergo PBPC transplantation allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation

Participant Flow:   Overall Study

	Treatment (Cyclophosphamide, Busulfan, Transplant)
STARTED	52
COMPLETED	51
NOT COMPLETED	1

  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

Treatment (Cyclophosphamide, Busulfan, Transplant)

CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV or PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1, 3, 6, and 11. cyclophosphamide: Given IV busulfan: Given IV tacrolimus: Given IV or PO methotrexate: Given IV cytogenetic analysis: Correlative studies flow cytometry: Correlative studies pharmacological study: Correlative studies pharmacogenomic studies: Correlative studies peripheral blood stem cell transplantation: Undergo PBPC transplantation allogeneic hematopoietic stem cell transplantation: Undergo allogeneic transplantation

Baseline Measures

	Treatment (Cyclophosphamide, Busulfan, Transplant)
Overall Participants Analyzed; [Units: Participants]	51
Age; [Units: Years]; Median (Full Range)	55; (30 to 65)
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	21 41.2%
Male	30 58.8%

  Outcome Measures

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1. Primary:

Effectiveness of Cyclophosphamide/Busulfan Regimen in Reducing Regimen-related Liver Toxicity [ Time Frame: Up to day +20 ]

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2. Primary:

Non-relapse Mortality (NRM) (Patients With AML/MDS) [ Time Frame: Up to day 200 ]

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  Limitations and Caveats

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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: H. Joachim Deeg MD
Organization: FHCRC
phone: 206 667 4409
e-mail: jdeeg@fhcrc.org

Responsible Party:	Joachim Deeg, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00445744 History of Changes
Other Study ID Numbers:	2130.00; NCI-2010-00270 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); P01HL036444 ( U.S. NIH Grant/Contract )
First Submitted:	March 7, 2007
First Posted:	March 9, 2007
Results First Submitted:	April 5, 2017
Results First Posted:	January 2, 2018
Last Update Posted:	January 2, 2018