Phase 2 Lymphoma Trial, Recruiting NCT04216524 Sponsor: M.D. Anderson Cancer Center Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT04216524
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with blastic plasmacytoid dendritic cell neoplasm (BPDCN), confirmed by tissue testing, who have either never received treatment or whose disease has come back or stopped responding to treatment.
  • People who are starting their first treatment may have already received some emergency chemotherapy before joining, including one prior cycle of a BPDCN-directed therapy such as SL-401.
  • People who have previously received or are currently receiving the drugs cytarabine (ARA-C) or hydroxyurea to control rapidly growing disease may still be considered.
  • People whose disease has returned or stopped responding to treatment and who have completed at least one prior cycle of therapy.
  • People aged 18 years or older.
  • People with a general health and activity level rated as reasonably functional (this is measured on a standard medical scale — confirm with trial site what this means for a specific situation).
  • People whose organs (including kidneys, liver, and protein levels in the blood) are working well enough to meet specific laboratory thresholds set by the trial (confirm with trial site for exact values).
  • People who are willing and able to read and sign a consent form agreeing to take part.
  • People who are able to attend all required study visits and follow-up appointments.
  • Women who could become pregnant, and men enrolled in the trial, must agree to use effective contraception during the study and for 2 months after the last dose of the study drug; acceptable methods include birth control pills or injections, intrauterine devices (IUDs), or a double-barrier method such as a condom used with spermicide. Men must also agree not to donate sperm during the study and for at least 8 weeks after their last dose of SL-401.
  • People whose heart is pumping effectively, confirmed by a heart scan (MUGA or echocardiogram) performed within 30 days before the first treatment.

Who may not be able to join:

  • People who are pregnant or breastfeeding.
  • People with a known active hepatitis B or hepatitis C infection, or who have tested positive for HIV.
  • People who have had major surgery or radiation therapy within the 14 days before the first study treatment.
  • People who have active or untreated disease affecting the membranes around the brain and spinal cord, or who have spinal cord compression causing symptoms.
  • People with serious heart disease, including those with significant heart failure, or who have had unstable chest pain, a stroke, or a heart attack within the past 6 months.
  • People who have difficulty absorbing medications through the digestive system or have other conditions that prevent taking medication by mouth.
  • People with other serious ongoing medical, mental health, or laboratory conditions that the trial doctor believes could make participation unsafe or affect the reliability of the trial results.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Naveen Pemmaraju, M.D. Anderson Cancer Center

Phone: 713-792-4956

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
29 May 2020
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Progression free survival (PFS); Incidence of adverse events; Overall response rate; Rate of stem cell transplant

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov