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Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01168219
Recruitment Status : Completed
First Posted : July 23, 2010
Results First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia
Adult Acute Monoblastic Leukemia
Adult Acute Monocytic Leukemia
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With Maturation
Adult Acute Myeloid Leukemia With Minimal Differentiation
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A
Adult Acute Myeloid Leukemia Without Maturation
Adult Acute Myelomonocytic Leukemia
Adult Erythroleukemia
Adult Pure Erythroid Leukemia
Alkylating Agent-Related Acute Myeloid Leukemia
de Novo Myelodysplastic Syndrome
Myelodysplastic Syndrome
Myelodysplastic Syndrome With Excess Blasts
Previously Treated Myelodysplastic Syndrome
Recurrent Adult Acute Myeloid Leukemia
Secondary Myelodysplastic Syndrome
Untreated Adult Acute Myeloid Leukemia
Interventions: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Biological: Anti-Thymocyte Globulin
Drug: Azacitidine
Drug: Busulfan
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Methotrexate
Other: Pharmacological Study
Drug: Tacrolimus

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From July 2010 and October 2013, a total of 68 participants were recruited to this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Chemotherapy and Transplant)

REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]).

TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.

GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).

CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1.


Participant Flow:   Overall Study
    Treatment (Chemotherapy and Transplant)
STARTED   68 
COMPLETED   68 
NOT COMPLETED   0 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Treatment (Chemotherapy and Transplant)

REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]).

TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.

GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).

CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1.


Baseline Measures
   Treatment (Chemotherapy and Transplant) 
Overall Participants Analyzed 
[Units: Participants]
 68 
Age 
[Units: Years]
Median (Full Range)
 62.9 
 (44.8 to 74.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  22.1% 
Male      53  77.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      3   4.4% 
Not Hispanic or Latino      61  89.7% 
Unknown or Not Reported      4   5.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   1.5% 
Asian      2   2.9% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   1.5% 
White      60  88.2% 
More than one race      2   2.9% 
Unknown or Not Reported      2   2.9% 
Region of Enrollment 
[Units: Participants]
 
United States   68 
Disease type 
[Units: Participants]
Count of Participants
 
Myelodysplastic Syndrome (MDS)      24  35.3% 
Acute Myeloid Leukemia (AML)      44  64.7% 


  Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: At 2 years ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Treatment Related Mortality (TRM)   [ Time Frame: Up to 6 months post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ravi Vij, MD
Organization: Washington University School of Medicine
e-mail: rvij@im.wustl.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01168219     History of Changes
Other Study ID Numbers: NCI-2011-02053
NCI-2011-02053 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CALGB-100801
CDR0000681025
CALGB 100801 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-100801 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: July 22, 2010
First Posted: July 23, 2010
Results First Submitted: March 5, 2018
Results First Posted: April 3, 2018
Last Update Posted: April 3, 2018