Status:
COMPLETED
Mitoxantrone and Clofarabine for Treatment of Recurrent NHL or Acute Leukemia
Lead Sponsor:
New York Medical College
Conditions:
Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE1
PHASE2
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 leu...
Eligibility Criteria
Inclusion
- 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.
- 1.2.2 (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
- Ejection fraction of \>50% by radionuclide angiogram or echocardiogram.
- Performance Status
- For patients age 1-16 years, Lansky score of ≥60.
- For patients \> 16 years, Karnofsky score of ≥60.
- Negative urine pregnancy test for females of child bearing age.
- Prior Therapy - Patients are eligible if they have been treated with clofarabine, mitoxantrone, or a combination of both in the past. However, the maximal lifetime cumulative previous anthracycline dose should not exceed doxorubicin dose equivalent of 450 mg/m2 (see Table 1). Patients who received more than one anthracycline prior to study entry should have each individual agent cumulative dose converted to doxorubicin equivalent and added together (eg, a patient who received cumulative dose of Daunorubicin at 200 mg/m2 and Mitoxantrone 48 mg/m2 has a total doxorubicin dose equivalent of 358.6 mg/m2 (200 mg/m2 x 0.833 + 48 mg/m2 x 4).
- Table 1. Anthracycline Conversion Agent Conversion Factor to Doxorubicin Dose Doxorubicin Multiply total dose x 1 Daunorubicin Multiply total dose x 0.833 Idarubicin Multiply total dose x 5 Mitoxantrone Multiply total dose x 4
- Informed Consent
- \- Patients or the patient's legally authorized guardian must be fully informed about their illness and the investigational nature of this protocol (including foreseeable risks and possible side effects), and must sign an informed consent in accordance with the institutional policies approved by the U.S. Department of Health and Human Services.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01842672
Start Date
March 1 2013
End Date
September 1 2022
Last Update
October 25 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
New York Medical College
Valhalla, New York, United States, 10595
2
Levine Children's Hospital
Charlotte, North Carolina, United States, 28204