A Phase 1 Trial of TST of PD 0332991 Followed by Cytarabine and Mitoxantrone for Adults With Relapsed and Refractory Acute Leukemias and High-Risk Myelodysplasia

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. Identifier: NCT01701375
Recruitment Status : Terminated (Material sponsor withdrew support)
First Posted : October 5, 2012
Results First Posted : September 9, 2013
Last Update Posted : September 9, 2013
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Relapsed Acute Leukemia
Refractory Acute Leukemia
High-Risk Myelodysplasia
Intervention: Drug: PD 0332991

  Participant Flow

  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.
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Reporting Groups
Arm 1
  • PD 0332991 will be given orally days 1,2,3
  • Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6
  • Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose

Baseline Measures
   Arm 1 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   2 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 45.5  (27) 
[Units: Participants]
Female   1 
Male   1 
Region of Enrollment 
[Units: Participants]
United States   2 

  Outcome Measures

1.  Primary:   The Toxicities of Administration of PD 0332991 in Combination With Cytarabine and Mitoxantrone.   [ Time Frame: 42 days ]

2.  Secondary:   To Determine the Maximal Tolerated Dose (MTD) of PD 0332991 in Timed Sequential Combination With Ara-C and Mitoxantrone   [ Time Frame: 42 days ]
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
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  More Information