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
Last Update Posted : October 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Minimal Residual Disease Leukemia, Lymphoblastic, Acute Leukemia, Myelogenous, Acute||Drug: Clofarabine Drug: Cytarabine Drug: Methotrexate||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 2012|
|Actual Study Completion Date :||October 2012|
- Drug: Clofarabine
20 mg/m2/day intravenously (IV) over 2 hours (given at hours 0 to 2) on days 1 through 5.Other Name: Clolar
- Drug: Cytarabine
1 gram/m2/day intravenously (IV) over 2 hours to be given 4 hours after the initiation of clofarabine on days 1 through 5.Other Name: AraC
- Drug: Methotrexate
Methotrexate to be given intrathecally (IT) to all acute lymphoblastic leukemia (ALL) patients on day 1 at the dose defined by age below:
Other Name: MTX
- 8 mg for patients age 1-1.99
- 10 mg for patients age 2-2.99
- 12 mg for patients 3-8.99 years of age
- 15 mg for patients >9 years of age
- Drug: 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:
Other Name: AraC
- 30 mg for patients age 1-1.99
- 50 mg for patients age 2-2.99
- 70 mg for patients >3 years of age
- Ability of clofarabine and cytarabine to eliminate minimal residual disease (MRD) in acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL) patients whose bone marrows exhibit complete remission by morphology. [ Time Frame: Day 22-36 of course 1 and 2 ]Patient's bone marrow will be evaluated for the amount of minimal residual disease (MRD) present after treatment on course 1 and 2.
- To describe the toxicity profile with this treatment [ Time Frame: Day 1-36 of course 1 and 2 ]All toxicities and adverse events will be collected throughout the study.
- To describe the toxicity profile during hematopoietic cell transplant (HCT) for patients who achieve remission and proceed to transplant. [ Time Frame: Every 3 months for life following completion or 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 determine the duration of complete remission after this treatment to minimize minimal residual disease. [ Time Frame: Every 3 months for life following completion or protocol therapy. ]If a patient eliminates all minimal residual disease (MRD) while being treated on this protocol. Data regarding the patient relapse will be collected to determine the length of remission.
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
Show 25 Study Locations
|Study Chair:||Blythe Thomson, MD||Seattle Children's Hospital|