Clinical Trial: Mitoxantrone and Clofarabine for Treatment of Recurrent NHL or Acute Leukemia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: The combination of mitoxantrone and clofarabine as reinduction therapy will be safe, well tolerated and effective in children, adolescents and young adults with poor risk refractory/relapsed acute leukemia and high grade non-Hodgkin lymphoma (NHL).

Detailed Summary:
Sponsor: New York Medical College

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: New York Medical College

Dates:
Date Received: April 22, 2013
Date Started: March 2013
Date Completion: December 2018
Last Updated: July 29, 2016
Last Verified: July 2016