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Trial record 3 of 325 for:    CYTARABINE AND DAUNORUBICIN

Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01804101
Recruitment Status : Completed
First Posted : March 5, 2013
Results First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roland Walter, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Biphenotypic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Untreated Adult Acute Myeloid Leukemia
Interventions Other: Laboratory Biomarker Analysis
Drug: Liposomal Cytarabine-Daunorubicin CPX-351
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Lower-dose CPX-351) Arm II (Higher Dose COX-351)
Hide Arm/Group Description

INDUCTION/RE-INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.

CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Liposomal Cytarabine-Daunorubicin CPX-351: Given IV

INDUCTION/RE-INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.

CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Liposomal Cytarabine-Daunorubicin CPX-351: Given IV

Period Title: Overall Study
Started 38 10
Completed 38 10
Not Completed 0 0
Arm/Group Title Arm I (Lower-dose Liposomal Cytarabine-daunorubicin CPX-351) Arm II (Closed to Accrual Effective 4/21/14) Total
Hide Arm/Group Description

INDUCTION/RE-INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.

CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Liposomal Cytarabine-Daunorubicin CPX-351: Given IV

INDUCTION/RE-INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.

CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Liposomal Cytarabine-Daunorubicin CPX-351: Given IV

Total of all reporting groups
Overall Number of Baseline Participants 38 10 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 10 participants 48 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  26.3%
2
  20.0%
12
  25.0%
>=65 years
28
  73.7%
8
  80.0%
36
  75.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 10 participants 48 participants
Female
13
  34.2%
3
  30.0%
16
  33.3%
Male
25
  65.8%
7
  70.0%
32
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 10 participants 48 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
38
 100.0%
10
 100.0%
48
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 10 participants 48 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
3
   7.9%
0
   0.0%
3
   6.3%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
35
  92.1%
10
 100.0%
45
  93.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 38 participants 10 participants 48 participants
38
 100.0%
10
 100.0%
48
 100.0%
1.Primary Outcome
Title Treatment-related Mortality Rate. (TRM)
Hide Description Estimate whether the 32 units/m2 or the 64 units/m2 or both dose levels of CPX-351 are likely to improve treatment-related mortality (TRM) rate while keeping the CR rate constant in patients with untreated high-risk MDS or non-APL AML at high risk of TRM.
Time Frame Up to 1 month after completion of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Lower-dose Liposomal Cytarabine-daunorubicin CPX-351) Arm II (Closed to Accrual Effective 4/21/14)
Hide Arm/Group Description:

INDUCTION/RE-INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.

CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Liposomal Cytarabine-Daunorubicin CPX-351: Given IV

INDUCTION/RE-INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.

CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Liposomal Cytarabine-Daunorubicin CPX-351: Given IV

Overall Number of Participants Analyzed 38 10
Measure Type: Count of Participants
Unit of Measure: Participants
6 2
2.Secondary Outcome
Title Overall Remission Rate (CR+CRp)
Hide Description Overall Remission Rate for the CR/CR with incomplete platelet count recovery (CRp) rate after up to 4 cycles of induction/re-induction therapy.
Time Frame Up to day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Lower-dose CPX-351) Arm II (Higher Dose COX-351)
Hide Arm/Group Description:

INDUCTION/RE-INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.

CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Liposomal Cytarabine-Daunorubicin CPX-351: Given IV

INDUCTION/RE-INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.

CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Liposomal Cytarabine-Daunorubicin CPX-351: Given IV

Overall Number of Participants Analyzed 38 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
  26.3%
1
  10.0%
Time Frame 3 years
Adverse Event Reporting Description SAE reporting per our institution, is if it's related and unexpected. None of our AE's met this criteria per protocol. AE's are were review by study coordinator and PI threw medical records and outside records from patients other physicians.
 
Arm/Group Title Arm I (Lower-dose Liposomal Cytarabine-daunorubicin CPX-351) Arm II (Closed to Accrual Effective 4/21/14)
Hide Arm/Group Description

INDUCTION/RE-INDUCTION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.

CONSOLIDATION: Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Liposomal Cytarabine-Daunorubicin CPX-351: Given IV

INDUCTION/RE-INDUCTION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or CRp continue on to consolidation.

CONSOLIDATION: Patients receive higher-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1 and 3. Treatment repeats every 40 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Liposomal Cytarabine-Daunorubicin CPX-351: Given IV

All-Cause Mortality
Arm I (Lower-dose Liposomal Cytarabine-daunorubicin CPX-351) Arm II (Closed to Accrual Effective 4/21/14)
Affected / at Risk (%) Affected / at Risk (%)
Total   10/38 (26.32%)      5/10 (50.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Lower-dose Liposomal Cytarabine-daunorubicin CPX-351) Arm II (Closed to Accrual Effective 4/21/14)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Lower-dose Liposomal Cytarabine-daunorubicin CPX-351) Arm II (Closed to Accrual Effective 4/21/14)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/38 (100.00%)      10/10 (100.00%)    
Blood and lymphatic system disorders     
epistaxis   2/38 (5.26%)  2 0/10 (0.00%)  0
Thrombocytopenia   7/38 (18.42%)  7 2/10 (20.00%)  2
Leukopenia   3/38 (7.89%)  3 1/10 (10.00%)  1
Endocrine disorders     
Increased Creatinine   3/38 (7.89%)  3 0/10 (0.00%)  0
Gastrointestinal disorders     
Constipation   5/38 (13.16%)  5 0/10 (0.00%)  0
Diarrhea   3/38 (7.89%)  3 0/10 (0.00%)  0
General disorders     
Fatigue   8/38 (21.05%)  8 2/10 (20.00%)  2
Edema   5/38 (13.16%)  5 0/10 (0.00%)  0
Infections and infestations     
Neutroprenic Fever   5/38 (13.16%)  5 2/10 (20.00%)  2
PICC Line infection   1/38 (2.63%)  1 1/10 (10.00%)  1
Neutropenia   9/38 (23.68%)  9 3/10 (30.00%)  3
hypoxemia   2/38 (5.26%)  2 1/10 (10.00%)  1
Metabolism and nutrition disorders     
Nausea   4/38 (10.53%)  4 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Roland B. Walter
Organization: Fred Hutchinson Cancer Center
Phone: 206-667-3599
EMail: rwalter@fredhutch.org
Layout table for additonal information
Responsible Party: Roland Walter, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01804101     History of Changes
Other Study ID Numbers: 2642.00
NCI-2013-00481 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2642
2642.00 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: March 1, 2013
First Posted: March 5, 2013
Results First Submitted: January 11, 2018
Results First Posted: May 25, 2018
Last Update Posted: May 25, 2018