SL-401 in Advanced, High Risk Myeloproliferative Neoplasms (Systemic Mastocytosis, Advanced Symptomatic Hypereosinoophic Disorder, Myelofibrosis, Chronic Myelomonocytic Leukemia)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02268253 |
Recruitment Status
:
Recruiting
First Posted
: October 20, 2014
Last Update Posted
: January 29, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myelofibrosis Chronic Myelomonocytic Leukemia | Drug: SL-401 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | SL-401 in Patients With Advanced, High Risk Myeloproliferative Neoplasms (Systemic Mastocytosis, Advanced Symptomatic Hypereosinoophic Disorder, Myelofibrosis, Chronic Myelomonocytic Leukemia) |
Study Start Date : | December 2014 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | June 2019 |

- Maximum Tolerated Dose [ Time Frame: Completed first cycle of therapy and for an expected 24 weeks ]Participants will be followed for the duration of the study, an expected 24 weeks

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All Patients (Stages 1 and 2):
- The patient is ≥18 years old
- The patient has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
-
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
- 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)
- The patient has signed informed consent prior to initiation of any study-specific procedures or treatment
- The patient is able to adhere to the study visit schedule and other protocol requirements, including follow-up for response assessments
- The patient 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
- 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):
- Patient has persistent clinically significant toxicities Grade ≥2 from previous chemotherapy not readily controlled by supportive measures (excluding alopecia, nausea, and fatigue)
- Patient has received treatment with chemotherapy, wide-field radiation, or biologic therapy within 14 days of study entry
- Patient has received treatment with another investigational agent within 14 days of study entry or concurrent treatment with another investigational agent.
- Patient has previously received treatment with SL-401 or has a known hypersensitivity to any components of the drug product
- 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
- 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 medication)
- 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
- 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
- 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
- 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
- Patient is pregnant or breast feeding
- Patient has known human immunodeficiency virus (HIV)
- Patient has evidence of active or chronic Hepatitis B or Hepatitis C infection.
- Patient is oxygen-dependent
- 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)

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): NCT02268253
Contact: Shay Shemesh, MS | 646-502-2309 | Trials@stemline.com |
United States, California | |
City of Hope | Recruiting |
Duarte, California, United States, 91010 | |
Contact: Haris Ali, M.D. 626-256-4673 ext 62684 harisali@coh.org | |
Principal Investigator: Haris Ali, M.D. | |
University of California, Los Angeles | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Gary Schiller, MD 310-825-5513 gschiller@mednet.ucla.edu | |
Principal Investigator: Gary Schiller, M.D. | |
United States, Kansas | |
University of Kansas Cancer Center | Recruiting |
Westwood, Kansas, United States, 66205 | |
Contact: Abdulraheem Yacoub, M.D. 913-588-6029 ayacoub@kumcc.edu | |
Principal Investigator: Abdulraheem Yacoub, M.D. | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Moshe Talpaz, MD mtalpaz@med.umich.edu | |
Principal Investigator: Moshe Talpaz, M.D. | |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Mrinal Patnaik, M.B.B.S.. patnaik.mrinal@mayo.edu | |
Principal Investigator: Mrinal Patnaik, M.B.B.S. | |
United States, New Jersey | |
Hackensack University Medical Center | Recruiting |
Hackensack, New Jersey, United States, 07601 | |
Contact: James McCloskey, M.D. jmccloskey@hackensackumc.org | |
Principal Investigator: James McCloskey, M.D. | |
United States, New York | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263 | |
Contact: Eunice Wang, MD 716-845-3544 eunice.wang@roswellpark.org | |
Principal Investigator: Eunice Wang, MD | |
Weill Cornell Medical Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Sangman Lee, M.D. sal9053@med.cornell.edu | |
Principal Investigator: Sangman Lee, M.D. | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Naveen Pemmaraju, M.D. 713-792-4956 npemmaraju@mdanderson.org | |
Principal Investigator: Naveen Pemmaraju, M.D. | |
Canada, Alberta | |
University of Alberta | Recruiting |
Edmonton, Alberta, Canada, T6G 2G3 | |
Contact: Minakshi Taparia, MD 780-407-1584 | |
Principal Investigator: Minakshi Taparia, M.D. | |
Canada, Ontario | |
Princess Margaret Cancer Centre | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Vikas Gupta, MD 416-946-4521 vikas.gupta@uhn.ca | |
Principal Investigator: Vikas Gupta, M.D. |
Responsible Party: | Stemline Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02268253 History of Changes |
Other Study ID Numbers: |
STML-401-0314 |
First Posted: | October 20, 2014 Key Record Dates |
Last Update Posted: | January 29, 2018 |
Last Verified: | January 2018 |
Additional relevant MeSH terms:
Leukemia Neoplasms Primary Myelofibrosis Leukemia, Myelomonocytic, Acute Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Juvenile Myeloproliferative Disorders Mastocytosis Mastocytosis, Systemic |
Neoplasms by Histologic Type Bone Marrow Diseases Hematologic Diseases Leukemia, Myeloid Myelodysplastic-Myeloproliferative Diseases Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin Diseases |