Mitoxantrone and Clofarabine for Treatment of Recurrent NHL or Acute Leukemia (MITCL)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01842672|
Recruitment Status : Recruiting
First Posted : April 30, 2013
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia Acute Myelogenous Leukemia Lymphoblastic Lymphoma Diffuse Large B-cell Lymphoma Burkitt Lymphoma/Leukemia||Drug: Clofarabine Drug: Mitoxantrone||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Mitoxantrone in Combination With Clofarabine (MITCL) in Children, Adolescents and Young Adults (CAYA) With Refractory/Relapsed Acute Leukemia or High Grade Non-Hodgkin Lymphoma|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Clofarabine Dose escalation starting 20 mg/m2/d days 1-5 Mitoxantrone 12 mg/m2/d days 3-6. Rituximab in patient with CD20+ disease only 375 mg/m2 day 1, 8, 15. IT Depocyt 35 or 50 mg/dose day 1 per cycle. IT ARA-C in children < 3 years age based dosing.
Dose Escalation of Clofarabine
Other Name: Novantrone
- Determine MTD [ Time Frame: 100 days ]2.1 To determine the maximal tolerated dose (MTD) and/or tolerable dose of escalating doses of clofarabine starting from 20mg/m2/day to 40mg/m2/day from Day 1 to Day 5 in combination with mitoxantrone 12mg/m2/day on Day 3-6 as reinduction therapy for children, adolescents and young adults with poor risk refractory/relapsed acute leukemia or high grade NHL.
- Response Rate [ Time Frame: 1 year ]To determine the overall complete and partial response rate (OR) of the combination of mitoxantrone and clofarabine as reinduction therapy for children, adolescents and young adults with refractory/relapsed acute leukemia or high grade NHL.
- Monitor for Minimal Residual Disease [ Time Frame: 1 Year ]To determine the percent of minimal residual disease (MRD) in the peripheral blood following reinduction with mitoxantrone and clofarabine reinduction therapy.
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): NCT01842672
|Contact: Mitchell Cairo, MDemail@example.com|
|Contact: Lauren Harrison, MSNfirstname.lastname@example.org|
|United States, New York|
|New York Medical College||Recruiting|
|Valhalla, New York, United States, 10595|
|Contact: Mitchell Cairo, MD 914-594-3650 email@example.com|
|Contact: Lauren Harrison, MSN 617-285-7844 firstname.lastname@example.org|
|United States, North Carolina|
|Levine Children's Hospital||Recruiting|
|Charlotte, North Carolina, United States, 28204|
|Contact: Javier Oesterheld, MD 704-381-9900 Javier.Oesterheld@carolinashealthcare.org|