SL-401 in Advanced, High Risk Myeloproliferative Neoplasms (Systemic Mastocytosis, Advanced Symptomatic Primary Eosinophilic Disorder, Myelofibrosis, Chronic Myelomonocytic Leukemia)

Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Age Range:18 - Any
Start Date:December 2014
End Date:December 2019
Contact:Shay Shemesh

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SL-401 in Patients With Advanced, High Risk Myeloproliferative Neoplasms (Systemic Mastocytosis, Advanced Symptomatic Primary Eosinophilic Disorder, Myelofibrosis, Chronic Myelomonocytic Leukemia)

This is a non-randomized open label multi-center study. Patients with high-risk
myeloproliferative neoplasms (systemic mastocytosis [SM], advanced symptomatic primary
eosinophilic disorder [PED], myelofibrosis [MF], and chronic myelomonocytic leukemia [CMML])
will be treated with SL-401, which will be administered as a brief intravenous infusion for 3
consecutive days initially every 21 days for 4 cycles; every 28 days for cycles 5-7; then
every 42 days. Stage 1 will consist of a period in which several doses of SL-401 are
evaluated. The Stage 2 portion will enroll up to 30 patients each with one of the two
myeloproliferative malignancies: MF and CMML. In entirety, the Stage 2 portion will consist
of up to 60 patients who will be treated at a maximum tolerated dose or maximum tested dose
in which multiple dose-limiting toxicities are not observed (identified in Stage 1).

Inclusion Criteria:

All Patients (Stages 1 and 2):

1. The patient is ≥18 years old.

2. The patient has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.

3. The patient has adequate baseline organ function, including cardiac, renal, and
hepatic function:

- Left ventricular ejection fraction (LVEF) ≥ institutional lower limit of normal
as measured by multigated acquisition scan or 2-dimensional (2-D) echocardiogram
within 28 days prior to start of therapy and no clinically significant
abnormalities on a 12-lead electrocardiogram (ECG)

- Serum creatinine ≤1.5 mg/dL (or ≤114 µmol/L)

- Serum albumin ≥3.2 g/dL (or ≥32 g/L) in the absence of receipt of (IV) albumin
within the previous 72 hours

- Bilirubin ≤1.5 mg/dL (or ≤26 µmol/L)

- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper
limit of normal (ULN)

- CPK ≤2.5 times the ULN

4. If a woman of child bearing potential, the patient has a negative serum or urine
pregnancy test within 1 week prior to SL-401 treatment (intervals shorter than 1 week
are acceptable, if required by institutional guidelines).

5. The patient has signed informed consent prior to initiation of any study-specific
procedures or treatment.

6. The patient is able to adhere to the study visit schedule and other protocol
requirements, including follow-up for response assessments.

7. The patient (either male or female) agrees to use acceptable contraceptive methods for
the duration of time in the study, and to continue to use acceptable contraceptive
methods for 2 months after the last SL-401 infusion.

8. Patient has an absolute neutrophil count (ANC) ≥0.5×10⁹/L.

Additional Inclusion Criteria Specific to Patients with MF and CMML (Stages 1 and 2)

Exclusion Criteria:

All Patients (Stages 1 and 2):

1. Patient has persistent clinically significant toxicities Grade ≥2 from previous
chemotherapy not readily controlled by supportive measures (excluding alopecia,
nausea, and fatigue).

2. Patient has received treatment with chemotherapy, wide-field radiation, or biologic
therapy within 14 days of study entry.

3. Patient has received treatment with another investigational agent within 14 days of
study entry or concurrent treatment with another investigational agent.

4. Patient has previously received treatment with SL-401 or has a known hypersensitivity
to any components of the drug product.

5. Patient has an active malignancy and/or cancer history (excluding myeloproliferative
disorders and concomitant myeloid malignancies as specified in the inclusion criteria)
that can confound the assessment of the study endpoints. Patients with a past cancer
history (within 2 years of entry) and/or ongoing active malignancy or substantial
potential for recurrence must be discussed with the Sponsor before study entry.
Patients with the following neoplastic diagnoses are eligible: non-melanoma skin
cancer, carcinoma in situ (including superficial bladder cancer), cervical
intraepithelial neoplasia, or organ-confined prostate cancer with no evidence of
progressive disease.

6. Patient has clinically significant cardiovascular disease (e.g., uncontrolled or any
New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled angina,
history of myocardial infarction or stroke within 6 months of study entry,
uncontrolled hypertension or clinically significant arrhythmias not controlled by

7. Patient has uncontrolled, clinically significant pulmonary disease (e.g., chronic
obstructive pulmonary disease, pulmonary hypertension) that, in the Investigator's
opinion, would put the patient at significant risk for pulmonary complications during
the study.

8. Patient has known active or suspected disease involvement of the central nervous
system (CNS). If suspected due to clinical findings, CNS disease should be ruled out
with relevant imaging and/or examination of cerebrospinal fluid.

9. Patient is receiving immunosuppressive therapy, with the exception of corticosteroids
as specified in the inclusion criteria and tacrolimus, for treatment or prophylaxis of
graft-versus-host disease (GVHD). If the patient has been on immunosuppressive
treatment or prophylaxis for GVHD, the treatment(s) must have been discontinued at
least 14 days prior to study drug and there must be no evidence of Grade ≥2 GVHD.

10. Patient has uncontrolled intercurrent illness including, but not limited to,
uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness
that would limit compliance with study requirements.

11. Patient is pregnant or breast feeding.

12. Patient has known human immunodeficiency virus (HIV).

13. Patient has evidence of active or chronic Hepatitis B or Hepatitis C infection.

14. Patient is oxygen-dependent.

15. Patient has any medical condition that in the Investigator's opinion place the patient
at an unacceptably high risk for toxicities.

Additional Exclusion Criteria Specific to Patients with MF and CMML (Stages 1 and 2)
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