Clinical Trial: NCT02135874 - My Cancer Genome

NCT02135874

Description:

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.

Related Conditions:

Acute Leukemia of Ambiguous Lineage

Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT02135874

Trial Eligibility

Document

Title

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

Clinical Trial IDs

ORG STUDY ID: 2013-0073
SECONDARY ID: NCI-2014-02322
SECONDARY ID: 2013-0073
NCT ID: NCT02135874

Conditions

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

Interventions

Drug	Synonyms	Arms
Clofarabine	Clofarex, Clolar	Treatment (combination chemotherapy)
Cytarabine	.beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453	Treatment (combination chemotherapy)
Dexamethasone	Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Fluorodelta, Fortecortin, Gammacorten, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex	Treatment (combination chemotherapy)
Idarubicin	4-Demethoxydaunomycin, 4-demethoxydaunorubicin, 4-DMDR	Treatment (combination chemotherapy)
Rituximab	ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Rituxan, Rituximab ABBS, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, rituximab biosimilar TQB2303, rituximab-abbs, RTXM83, Truxima	Treatment (combination chemotherapy)
Sorafenib	BA4 43 9006, BAY 43-9006, Bay-439006	Treatment (combination chemotherapy)
Sorafenib Tosylate	BAY 43-9006 Tosylate, BAY 54-9085, Nexavar, sorafenib	Treatment (combination chemotherapy)
Vincristine	LEUROCRISTINE, VCR, Vincrystine	Treatment (combination chemotherapy)
Vincristine Sulfate	Kyocristine, Leurocristine sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate	Treatment (combination chemotherapy)

Purpose

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.

Trial Arms

Name	Type	Description	Interventions
Treatment (combination chemotherapy)	Experimental	See Detailed Description.	Clofarabine Cytarabine Dexamethasone Idarubicin Rituximab Sorafenib Sorafenib Tosylate Vincristine Vincristine Sulfate

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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Response (complete response or overall response rate)
Time Frame:	Up to 2 months
Safety Issue:
Description:	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.

Secondary Outcome Measures

Measure:	4-week mortality rate (Newly diagnosed patients)
Time Frame:	At 4 weeks
Safety Issue:
Description:	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.

Measure:	Incidence of toxicity (Newly diagnosed patients)
Time Frame:	Up to 4 weeks after completion of study treatment
Safety Issue:
Description:	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.

Measure:	4-week mortality rate (Relapsed patients)
Time Frame:	At 4 weeks
Safety Issue:
Description:

Measure:	Incidence of toxicity (Relapsed patients)
Time Frame:	Up to 4 weeks after completion of study treatment
Safety Issue:
Description:	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.

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	M.D. Anderson Cancer Center

Last Updated

April 28, 2021

Clinical Trials /

Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia