Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

SL-401 in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia

Protocol: OSU-13247

Full Title

SL-401 in Patients with Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm

Purpose

This is a non-randomized, open-label, multi center study. A cycle of therapy is 5

consecutive days every 21 days for 6 or more cycles. Stage I will consist of a brief run-in

period in which patients with BPDCN (previously untreated and previously treated) and AML

(persistent/recurrent and previously untreated) will be treated with SL-401 at 3 dose

levels. During Stage 2, two cohorts of BPDCN and AML patients will be treated at the maximum

tolerated dose or maximum tested dose in which multiple dose-limiting toxicities are not

observed (identified in Stage 1).

Are you eligible?

Inclusion Criteria:

Stage 1

Inclusion Criteria:

1. The patient has a diagnosis of AML or BPDCN according to WHO classification (AML;

excluding acute promyelocytic leukemia [APL, FAB M3]) or confirmed by hematopathology

(BPDCN)

2. The patient must meet one of the following (a) or (b) or (c):

1. Has evidence of persistent or recurrent AML in the peripheral blood and/or bone

marrow that is refractory to, or has relapsed from, their most recent prior line

of treatment.

A prior line of treatment is considered an induction regimen if it involves

an approved or investigational cytotoxic chemotherapy agent, biological

agent, and/or hypomethylating agent administered alone or in a combination

regimen, with the intent to induce robust cytoreduction (i.e., CR).

The previous induction regimen may have been a SCT with intent to induce a

CR.

Consolidation and/or maintenance (including SCT) may have been given in

CR/CRi, but are not counted as a line of treatment.

Hydroxyurea will not be considered a prior line of treatment.

2. Has previously untreated AML and is considered to be at high risk for disease

progression and/or is unlikely to derive more than transient benefit from

standard therapy by having at least one of the following:

Treatment-related AML, except if it is associated with favorable

cytogenetics (e.g., inversion 16, t(16;16), t(8;21), t(15;17)).

AML with antecedent hematological disease (e.g., myelodysplastic syndrome

(MDS), myelofibrosis, polycythemia vera, etc.) and not a candidate for stem

cell transplantation (SCT) in their current disease state.

3. Has histological and/or cytological evidence of BPDCN in the peripheral blood,

bone marrow, spleen, lymph nodes, skin, and/or other sites that is either

previously untreated or is persistent/recurrent following prior treatment for

BPDCN.

3. The patient is ≥ 18 years old.

4. The patient has an ECOG performance score (PS) of 0-2.

5. The patient has adequate baseline organ function, including cardiac, renal, and

hepatic function:

Left ventricular ejection fraction (LVEF) ≥ 40% as measured by MUGA scan or 2-D

ECHO within 28 days prior to start of therapy and no clinically significant

abnormalities on a 12-lead ECG

Serum creatinine ≤ 1.5 mg/dl

Serum albumin ≥ 3.0 g/dl

Bilirubin ≤ 1.5 mg/dl

AST and ALT ≤ 2.5 times the upper limit of normal (ULN)

6. If the patient is a woman of child bearing potential (WOCBP), she has had a negative

serum or urine pregnancy test within 1 week prior to treatment.

7. The patient has signed informed consent prior to initiation of any study-specific

procedures or treatment.

8. The patient is able to adhere to the study visit schedule and other protocol

requirements, including follow-up for survival assessment.

Inclusion Criteria:

1. The patient has a diagnosis of AML or BPDCN according to WHO classification (AML;

excluding acute promyelocytic leukemia [APL, FAB M3]) or confirmed by hematopathology

(BPDCN)

2. The patient must meet one of the following (a) or (b) or (c):

1. Has evidence of persistent or recurrent AML in the peripheral blood and/or bone

marrow that is refractory to, or has relapsed from, their most recent prior line

of treatment.

A prior line of treatment is considered an induction regimen if it involves

an approved or investigational cytotoxic chemotherapy agent, biological

agent, and/or hypomethylating agent administered alone or in a combination

regimen, with the intent to induce robust cytoreduction (i.e., CR).

The previous induction regimen may have been a SCT with intent to induce a

CR.

Consolidation and/or maintenance (including SCT) may have been given in

CR/CRi, but are not counted as a line of treatment.

Hydroxyurea will not be considered a prior line of treatment.

2. Has previously untreated AML and is considered to be at high risk for disease

progression and/or is unlikely to deriv

Exclusion Criteria:

Stage 1

Inclusion Criteria:

1. The patient has a diagnosis of AML or BPDCN according to WHO classification (AML;

excluding acute promyelocytic leukemia [APL, FAB M3]) or confirmed by hematopathology

(BPDCN)

2. The patient must meet one of the following (a) or (b) or (c):

1. Has evidence of persistent or recurrent AML in the peripheral blood and/or bone

marrow that is refractory to, or has relapsed from, their most recent prior line

of treatment.

A prior line of treatment is considered an induction regimen if it involves

an approved or investigational cytotoxic chemotherapy agent, biological

agent, and/or hypomethylating agent administered alone or in a combination

regimen, with the intent to induce robust cytoreduction (i.e., CR).

The previous induction regimen may have been a SCT with intent to induce a

CR.

Consolidation and/or maintenance (including SCT) may have been given in

CR/CRi, but are not counted as a line of treatment.

Hydroxyurea will not be considered a prior line of treatment.

2. Has previously untreated AML and is considered to be at high risk for disease

progression and/or is unlikely to derive more than transient benefit from

standard therapy by having at least one of the following:

Treatment-related AML, except if it is associated with favorable

cytogenetics (e.g., inversion 16, t(16;16), t(8;21), t(15;17)).

AML with antecedent hematological disease (e.g., myelodysplastic syndrome

(MDS), myelofibrosis, polycythemia vera, etc.) and not a candidate for stem

cell transplantation (SCT) in their current disease state.

3. Has histological and/or cytological evidence of BPDCN in the peripheral blood,

bone marrow, spleen, lymph nodes, skin, and/or other sites that is either

previously untreated or is persistent/recurrent following prior treatment for

BPDCN.

3. The patient is ≥ 18 years old.

4. The patient has an ECOG performance score (PS) of 0-2.

5. The patient has adequate baseline organ function, including cardiac, renal, and

hepatic function:

Left ventricular ejection fraction (LVEF) ≥ 40% as measured by MUGA scan or 2-D

ECHO within 28 days prior to start of therapy and no clinically significant

abnormalities on a 12-lead ECG

Serum creatinine ≤ 1.5 mg/dl

Serum albumin ≥ 3.0 g/dl

Bilirubin ≤ 1.5 mg/dl

AST and ALT ≤ 2.5 times the upper limit of normal (ULN)

6. If the patient is a woman of child bearing potential (WOCBP), she has had a negative

serum or urine pregnancy test within 1 week prior to treatment.

7. The patient has signed informed consent prior to initiation of any study-specific

procedures or treatment.

8. The patient is able to adhere to the study visit schedule and other protocol

requirements, including follow-up for survival assessment.

Inclusion Criteria:

1. The patient has a diagnosis of AML or BPDCN according to WHO classification (AML;

excluding acute promyelocytic leukemia [APL, FAB M3]) or confirmed by hematopathology

(BPDCN)

2. The patient must meet one of the following (a) or (b) or (c):

1. Has evidence of persistent or recurrent AML in the peripheral blood and/or bone

marrow that is refractory to, or has relapsed from, their most recent prior line

of treatment.

A prior line of treatment is considered an induction regimen if it involves

an approved or investigational cytotoxic chemotherapy agent, biological

agent, and/or hypomethylating agent administered alone or in a combination

regimen, with the intent to induce robust cytoreduction (i.e., CR).

The previous induction regimen may have been a SCT with intent to induce a

CR.

Consolidation and/or maintenance (including SCT) may have been given in

CR/CRi, but are not counted as a line of treatment.

Hydroxyurea will not be considered a prior line of treatment.

2. Has previously untreated AML and is considered to be at high risk for disease

progression and/or is unlikely to deriv

Acute Myeloid Leukemia Leukemia