Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia
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|ClinicalTrials.gov Identifier: NCT02135874|
Recruitment Status : Recruiting
First Posted : May 12, 2014
Last Update Posted : February 27, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Acute Bilineal Leukemia Acute Biphenotypic Leukemia Acute Leukemia of Ambiguous Lineage Acute Undifferentiated Leukemia Mixed Phenotype Acute Leukemia Mixed Phenotype Acute Leukemia, B/Myeloid, Not Otherwise Specified Mixed Phenotype Acute Leukemia, T/Myeloid, Not Otherwise Specified Recurrent Mixed Phenotype Acute Leukemia||Drug: Clofarabine Drug: Cytarabine Drug: Dexamethasone Drug: Idarubicin Biological: Rituximab Drug: Sorafenib Drug: Sorafenib Tosylate Drug: Vincristine Drug: Vincristine Sulfate||Phase 2|
I. To evaluate the response rate of the chemotherapy regimen in patients with mixed phenotype acute leukemia.
I. To evaluate the durability of response, the overall and event-free survival rates, and the safety profile of the regimen.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Clofarabine, Idarubicin, Cytarabine, Vincristine, and Corticosteroids for Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia|
|Actual Study Start Date :||October 27, 2014|
|Estimated Primary Completion Date :||December 31, 2034|
|Estimated Study Completion Date :||December 31, 2034|
Experimental: Treatment (combination chemotherapy)
See Detailed Description.
Drug: Sorafenib Tosylate
Drug: Vincristine Sulfate
- Response (complete response or overall response rate) [ Time Frame: Up to 2 months ]The two groups of patients (newly diagnosed or relapsed/refractory) will be evaluated separately. The posterior response rate and their 95% credible intervals will be estimated.
- 4-week mortality rate (Newly diagnosed patients) [ Time Frame: At 4 weeks ]For discrete or categorical data, descriptive statistics will include tabulations of frequencies. For continuous data, summary statistics including n, mean, standard deviation, median, minimum and maximum will be computed.
- Incidence of toxicity (Newly diagnosed patients) [ Time Frame: Up to 4 weeks after completion of study treatment ]Will be defined as any grade 3 or greater clinically significant non-hematological toxicity related to treatment. Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. For discrete or categorical data, descriptive statistics will include tabulations of frequencies.
- 4-week mortality rate (Relapsed patients) [ Time Frame: At 4 weeks ]
- Incidence of toxicity (Relapsed patients) [ Time Frame: Up to 4 weeks after completion of study treatment ]Will be defined as any grade 3 or greater clinically significant non hematological toxicity related to treatment. Graded according to NCI CTCAE version 4.0.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Breast feeding females
- Patients with active, uncontrolled infections
- Patients with active secondary malignancy will not be eligible unless approved by the principal investigator
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): NCT02135874
|Contact: Elias Jabbouremail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Elias Jabbour 713-792-4764|
|Principal Investigator: Elias Jabbour|
|Principal Investigator:||Elias Jabbour||M.D. Anderson Cancer Center|
|Responsible Party:||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
NCI-2014-02322 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2013-0073 ( Other Identifier: M D Anderson Cancer Center )
|First Posted:||May 12, 2014 Key Record Dates|
|Last Update Posted:||February 27, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Leukemia, Biphenotypic, Acute
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Immunological
Physiological Effects of Drugs