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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


Phase 1/Phase 2
N/A
30 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Lymphoblastic Lymphoma, Diffuse Large B-cell Lymphoma, Burkitt Lymphoma/Leukemia

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine MTD

Outcome Description:

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.

Outcome Time Frame:

100 days

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

NYMC 542

NCT ID:

NCT01842672

Start Date:

March 2013

Completion Date:

December 2018

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Acute Myelogenous Leukemia
  • Lymphoblastic Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Burkitt Lymphoma/Leukemia
  • pediatric non-hodgkins lymphoma
  • pediatric acute leukemia
  • clofarabine
  • mitoxantrone
  • Burkitt Lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

New York Medical CollegeValhalla, New York  10595