NCT02135874 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2024-03-22

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Participants Complete Response

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outcome · POSTED

4-week Mortality Rate

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
See Detailed Description.
intervention Names
Drug: Clofarabine
Drug: Cytarabine
Drug: Dexamethasone
Drug: Idarubicin
Biological: Rituximab
Drug: Sorafenib
Drug: Sorafenib Tosylate
Drug: Vincristine
Drug: Vincristine Sulfate
label
Treatment (combination chemotherapy)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (combination chemotherapy)
description
Given IV
name
Clofarabine
other Names
Clofarex
Clolar
type
DRUG
arm Group Labels
Treatment (combination chemotherapy)
description
Given IV
name
Cytarabine
other Names
.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
type
DRUG
arm Group Labels
Treatment (combination chemotherapy)
description
Given IV
name
Dexamethasone
other Names
Aacidexam
Adexone
Aknichthol Dexa
Alba-Dex
Alin
Alin Depot
Alin Oftalmico
Amplidermis
Anemul mono
Auricularum
Auxiloson
Baycadron
type
DRUG
arm Group Labels
Treatment (combination chemotherapy)
description
Given IV
name
Idarubicin
other Names
4-Demethoxydaunomycin
4-demethoxydaunorubicin
4-DMDR
type
DRUG
arm Group Labels
Treatment (combination chemotherapy)
description
Given IV
name
Rituximab
other Names
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
type
BIOLOGICAL
arm Group Labels
Treatment (combination chemotherapy)
description
Given PO
name
Sorafenib
other Names
BA4 43 9006
BAY 43-9006
Bay-439006
type
DRUG
arm Group Labels
Treatment (combination chemotherapy)
description
Given PO
name
Sorafenib Tosylate
other Names
BAY 43-9006 Tosylate
BAY 54-9085
Nexavar
sorafenib
type
DRUG
arm Group Labels
Treatment (combination chemotherapy)
description
Given IV
name
Vincristine
other Names
LEUROCRISTINE
VCR
Vincrystine
type
DRUG
arm Group Labels
Treatment (combination chemotherapy)
description
Given IV
name
Vincristine Sulfate
other Names
Kyocristine
Leurocristine sulfate
Leurocristine, sulfate
Oncovin
Vincasar
Vincosid
Vincrex
Vincristine, sulfate
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 16
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Response is Complete Response (CR) is Neutrophil count \>/= 1.0 x 10\^9/L, . Platelet count \>/= 100 x 10\^9/L, Bone marrow aspirate \< 5% blasts, No extramedullary leukemia.
measure
Participants Complete Response
time Frame
Up to 2 months

secondary Outcomes

description
Number of participants who died after 4 weeks of treatment.
measure
4-week Mortality Rate
time Frame
At 4 weeks

Full study description

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.

Source references