Brief Title
Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia
Official Title
A Phase 2 Study of Clofarabine, Idarubicin, Cytarabine, Vincristine, and Corticosteroids for Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia
Brief Summary
This phase II trial studies how well clofarabine, idarubicin, cytarabine, vincristine
sulfate, and dexamethasone work in treating patients with mixed phenotype acute leukemia that
is newly diagnosed or has returned after a period of improvement (relapsed). Drugs used in
chemotherapy, such as clofarabine, idarubicin, cytarabine, vincristine sulfate, and
dexamethasone, work in different ways to stop the growth of cancer cells, either by killing
the cells, by stopping them from dividing, or by stopping them from spreading.
Detailed Description
PRIMARY OBJECTIVE:
I. To evaluate the response rate of the chemotherapy regimen in patients with mixed phenotype
acute leukemia.
SECONDARY OBJECTIVE:
I. To evaluate the durability of response, the overall and event-free survival rates, and the
safety profile of the regimen.
OUTLINE:
INDUCTION THERAPY: Patients receive clofarabine intravenously (IV) over 60 minutes on days
1-4 or 1-3; idarubicin IV over 30-60 minutes on days 1-3 or 1-2; cytarabine IV over 2 hours
on days 1-4; vincristine sulfate IV over 15-30 minutes on days 1, 8, and 15; and
dexamethasone IV over 10-30 minutes on days 1-4 and 15-18. Patients with a certain type of
leukemia may receive rituximab IV over 4-6 hours on days 1 and 8 or sorafenib tosylate orally
(PO) twice daily (BID) on days 1-14. Treatment repeats every 28 days for up to 2 cycles in
the absence of disease progression or unacceptable toxicity.
CONSOLIDATION THERAPY: Patients receive clofarabine IV over 60 minutes on days 1-3 or 1-2;
idarubicin IV over 30-60 minutes on days 1-2; cytarabine IV over 2 hours on days 1-3 or 1-2;
vincristine sulfate IV over 15-30 minutes on days 1, 8, and 15; and dexamethasone IV over
10-30 minutes on days 1-4 and 15-18. Patients with a certain type of leukemia may receive
rituximab IV over 4-6 hours on days 1 and 8 of cycles 1-3 or sorafenib tosylate PO BID on
days 1-28 of cycle 1-6 and beyond. Treatment repeats every 28 days for up to 6 cycles in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 6
months thereafter.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response (complete response or overall response rate)
Secondary Outcome
4-week mortality rate (Newly diagnosed patients)
Condition
Acute Bilineal Leukemia
Intervention
Clofarabine
Study Arms / Comparison Groups
Treatment (combination chemotherapy)
Description: See Detailed Description.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
60
Start Date
October 27, 2014
Completion Date
October 30, 2020
Primary Completion Date
October 30, 2020
Eligibility Criteria
Inclusion Criteria:
- Sign an informed consent document
- Newly diagnosed or relapsed mixed phenotype acute leukemia (MPAL), which for this
protocol, will be defined as follows: bone marrow result interpreted by the reading
pathologist (or tissue biopsy for cases of extramedullary disease) as: biphenotypic
leukemia, bilineal leukemia, undifferentiated leukemia, mixed lineage leukemia,
leukemia of ambiguous lineage, T/myeloid leukemia, B/myeloid leukemia, or other
diagnosis indicating the presence of multiple lineages within the cell population
- Eastern Cooperative Oncology Group (ECOG) performance status of =< 3 at study entry
- Adequate organ function as outlined below (unless due to leukemia)
- Serum creatinine =< 3 mg/dL
- Total bilirubin =< 2.5 mg/dL
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) and/or
aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 3
x upper limit of normal (ULN) or =< 5 x ULN if related to disease
- Women of childbearing potential must have a negative serum or urine pregnancy test
within 7 days; women of childbearing potential and men must agree to use contraception
at study entry and for the duration of active study treatment
- Cardiac ejection fraction >= 40% (by either cardiac echocardiogram [echo] or multi
gated acquisition [MUGA] scan); documentation of recent (=< 6 months from screening)
outside reports is acceptable
- If newly diagnosed, prior therapy with hydrea and/or steroid and the use of a single
or a two day dose of cytarabine (up to 3 g/m^2), for emergency use up to 24 hours
prior to start of study therapy is allowed
Exclusion Criteria:
- Breast feeding females
- Patients with active, uncontrolled infections
- Patients with active secondary malignancy will not be eligible unless approved by the
principal investigator
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Elias Jabbour, 713-792-4764, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02135874
Organization ID
2013-0073
Secondary IDs
NCI-2014-02322
Responsible Party
Sponsor
Study Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Elias Jabbour, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
December 2019