Tagraxofusp (SL-401) in Patients With CMML or MF

  • STATUS
    Recruiting
  • End date
    Jul 24, 2022
  • participants needed
    130
  • sponsor
    Stemline Therapeutics, Inc.
Updated on 24 January 2021
platelet count
anemia
myelofibrosis
hydroxyurea
chronic myelomonocytic leukemia
ejection fraction
leukemia
neutrophil count
dysplasia
myelomonocytic leukemia
monocytosis
cmml-2
thrombocytosis

Summary

This multi-center, multi-arm trial is evaluating the safety and efficacy of tagraxofusp, a CD123-targeted therapy, in patients with either chronic myelomonocytic leukemia (CMML) or myelofibrosis (MF). There are two CMML cohorts, one enrolling patients with CMML (CMML-1 or CMML-2) who are refractory/resistant or intolerant to hypomethylating agents (HMA), hydroxyurea (HU), or intensive chemotherapy; and one enrolling treatment-naive patients with CMML (CMML-1 or CMML-2) with molecular features associated with poor prognosis. The MF cohort will enroll patients who are resistant/refractory or intolerant to approved JAK therapy (JAK1/JAK2 or JAK2).

Details
Condition Chronic myelomonocytic leukemia, Juvenile Myelomonocytic Leukemia, Myelosclerosis with myeloid metaplasia, Advanced Systemic Mastocytosis, Advanced Symptomatic Primary Eosinophilic Disorder, Myelofibrosis, chronic myelomonocytic leukaemia, cmml
Treatment SL-401
Clinical Study IdentifierNCT02268253
SponsorStemline Therapeutics, Inc.
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Clinically significant cardiovascular disease, pulmonary disease, or known active or suspected disease involvement of the central nervous system (CNS)
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)
Uncontrolled intercurrent illness
Patient is pregnant or breast feeding
Patient has known human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
Patient is oxygen-dependent
Additional Exclusion Criteria Specific to Patients with MF and CMML (Stages 2
and 3A) apply

Exclusion Criteria

All Patients (Stages 2 and 3A)
Persistent clinically significant toxicities Grade 2 from previous therapies not readily controlled by supportive measures (excluding alopecia, nausea, and fatigue)
Treatment with any disease-related therapy, including radiation therapy or investigational agent, within 14 days of study entry
Allogeneic SCT within 3 months of study entry
Previous treatment with tagraxofusp or known hypersensitivity to any components of the drug product
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note