Clofarabine With Cytarabine for Patients With Minimal Residual Disease Positive Leukemia
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|ClinicalTrials.gov Identifier: NCT01158885|
Recruitment Status : Terminated (Study terminated for lack of accrual.)
First Posted : July 8, 2010
Results First Posted : October 7, 2019
Last Update Posted : October 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Minimal Residual Disease Leukemia, Lymphoblastic, Acute Leukemia, Myelogenous, Acute||Drug: Clofarabine Drug: Cytarabine intravenous Drug: Methotrexate Drug: Intrathecal (IT) Cytarabine||Phase 2|
Recent studies have demonstrated that even low levels of minimum residual disease (MRD) (>0.01% abnormal blasts) after aggressive re-induction therapy indicate a relatively poor outcome in relapsed acute lymphoblastic leukemia (ALL) patients, including those who proceed to allogeneic stem cell transplant (alloSCT). A similarly poor prognosis was seen in pediatric acute myelogenous leukemia patients with sub-morphologic disease prior to alloSCT. Studies to identify therapies that can eliminate persistent leukemia, have low toxicity profiles and can serve as a bridge to transplant are needed.
This study will test the ability of clofarabine + cytarabine to eliminate minimal residual disease (MRD) in acute myelogenous leukemia and acute lymphoblastic leukemia patients whose bone marrows exhibit complete remission by morphology. The toxicity profile of this regimen will be evaluated in addition to toxicity experienced by patients who proceed to stem cell transplant. Overall length of remission will also be collected.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clofarabine With Cytarabine for MRD Positive Leukemia|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||October 24, 2012|
|Actual Study Completion Date :||October 24, 2012|
Experimental: Single Arm
A maximum of two courses of the following regimen will be administered.
20 mg/m2/day intravenously (IV) over 2 hours (given at hours 0 to 2) on days 1 through 5.
Drug: Cytarabine intravenous
1 gram/m2/day intravenously (IV) over 2 hours to be given 4 hours after the initiation of clofarabine on days 1 through 5.
Methotrexate to be given intrathecally (IT) to all acute lymphoblastic leukemia (ALL) patients on day 1 at the dose defined by age below:
Drug: Intrathecal (IT) Cytarabine
Intrathecal (IT) cytarabine is optional for acute myelogenous leukemia (AML) patients.
If intrathecal cytarabine is to be given, it must be given at least 72 hours but not more than 7 days prior to the initiation of intravenous cytarabine.
Dose should be given according to age as defined below:
- Minimal Residual Disease (MRD) [ Time Frame: Sample collected between Days 22-36 of courses 1 and 2 ]To be assessed in acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL) patients whose bone marrows exhibit complete remission by morphology. Patient's bone marrow will be evaluated for the amount of minimal residual disease (MRD) present after treatment on courses 1 and 2.
- Occurrence of a Dose-Limiting Toxicity [ Time Frame: Beginning with the first dose of investigational product until 30 days following the last dose of clofarabine ]All toxicities and adverse events will be collected from the first dose of study drug until 30 days following the last dose of Clofarabine
- Occurrence of Toxicity During Hematopoietic Cell Transplant (HCT) for Patients Who Achieve Remission and Proceed to Transplant [ Time Frame: Every 3 months for life following completion of protocol therapy. ]After the patient completes therapy on this protocol, data will continue to be collected regarding whether the patient proceeded to HCT. Toxicity and adverse event information will be collected.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158885
|United States, North Carolina|
|Carolina-Levine Children's Hospital|
|Charlotte, North Carolina, United States, 28204|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Study Chair:||Blythe Thomson, MD||Seattle Children's Hospital|