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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| 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) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Mitoxantrone/Clofarabine
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.
|
Drug: Clofarabine
Dose Escalation of Clofarabine
Other Names:
Drug: Mitoxantrone 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
5.1.2.2 (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 Criteria:
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.
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, MD | 914-594-3650 | mitchell_cairo@nymc.edu | |
| Contact: Lauren Harrison, MSN | 617-285-7844 | lauren_harrison@nymc.edu |
| United States, New York | |
| New York Medical College | Recruiting |
| Valhalla, New York, United States, 10595 | |
| Contact: Mitchell Cairo, MD 914-594-3650 mitchell_cairo@nymc.edu | |
| Contact: Lauren Harrison, MSN 617-285-7844 lauren_harrison@nymc.edu | |
| 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 | |
| Responsible Party: | New York Medical College |
| ClinicalTrials.gov Identifier: | NCT01842672 History of Changes |
| Other Study ID Numbers: |
NYMC 542 L 10, 819 ( Other Identifier: New York Medical College Institutional Review Board ) |
| First Posted: | April 30, 2013 Key Record Dates |
| Last Update Posted: | March 29, 2018 |
| Last Verified: | March 2018 |
Keywords provided by New York Medical College:
|
pediatric non-hodgkins lymphoma pediatric acute leukemia clofarabine mitoxantrone |
Additional relevant MeSH terms:
|
Lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma, B-Cell Burkitt Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections Mitoxantrone Clofarabine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors |