Mitoxantrone and Clofarabine for Treatment of Recurrent NHL or Acute Leukemia
MITCL
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
2 other identifiers
interventional
41
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2013
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 22, 2013
CompletedFirst Posted
Study publicly available on registry
April 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedOctober 25, 2022
October 1, 2022
8.4 years
April 22, 2013
October 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine MTD
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.
100 days
Secondary Outcomes (2)
Response Rate
1 year
Monitor for Minimal Residual Disease
1 Year
Study Arms (1)
Mitoxantrone/Clofarabine
EXPERIMENTALClofarabine 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.
Interventions
Dose Escalation of Clofarabine
Eligibility Criteria
You may qualify if:
- Age ≤30.99 years old
- Disease Status (Part A - Safety Phase)
- ALL in 1st, 2nd or 3rd relapse OR primary induction failure.
- AML in 1st ,2nd or 3rd relapse OR primary induction failure.
- T-or B -- Lymphoblastic Lymphoma (T-LBL, B-LBL); Diffuse Large B-cell Lymphoma (DLBCL) or Burkitt Lymphoma/Leukemia in 1st, 2nd or 3rd relapse OR primary induction failure.
- (Part B - Efficacy Phase)
- ALL in 2nd or 3rd relapse OR primary induction failure.
- AML in 2nd or 3rd relapse OR primary induction failure.
- T-or B -- Lymphoblastic Lymphoma (T-LBL, B-LBL); Diffuse Large B-cell Lymphoma (DLBCL) or Burkitt Lymphoma/Leukemia in 1st, 2nd or 3rd relapse OR primary induction failure.
- Adequate renal function defined as:
- \- Normal Serum creatinine based on age or Creatinine clearance \> 60 ml/min or \>60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (GFR) as determined by the institutional normal range.
- Adequate liver function defined as:
- Direct bilirubin \< 1.5 upper limit of normal (ULN) for age, and SGOT (AST) or SGPT (ALT) \<3 x ULN
- Adequate cardiac function defined as:
- Shortening fraction \>27% by echocardiogram, or
- +9 more criteria
You may not qualify if:
- Patients with prior myeloablative allogeneic stem cell transplantation \<3 months prior to proposed enrollment on study and/or ≥Grade II active acute GVHD or extensive chronic GVHD.
- Females who are pregnant (positive HCG) or lactating.
- Karnofsky \<60% or Lansky \<60% if less than 16 years of age.
- Age \>30.99 years of age.
- Patients with active CNS disease.
- Any patient with uncontrolled infection prior to study entry.
- Patients with Down syndrome are excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
New York Medical College
Valhalla, New York, 10595, United States
Levine Children's Hospital
Charlotte, North Carolina, 28204, United States
Related Publications (1)
Hochberg J, Oesterheld J, Gardenswartz A, Flower A, Klejmont L, Basso J, Shi Q, Harrison L, Borowitz MJ, Loken MR, Cairo MS. Mitoxantrone in combination with clofarabine (MITCL) in children, adolescents and young adults with relapsed/refractory acute leukaemia: final results of a phase I/II trial. EClinicalMedicine. 2025 Apr 28;83:103211. doi: 10.1016/j.eclinm.2025.103211. eCollection 2025 May.
PMID: 40641817DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2013
First Posted
April 30, 2013
Study Start
March 1, 2013
Primary Completion
August 1, 2021
Study Completion
September 1, 2022
Last Updated
October 25, 2022
Record last verified: 2022-10