Autopsy report · NCT01453140

In-vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus

“Dose Limiting Toxicities”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months after it had already started.
• Ran for about 11 months before it stopped.
• 3 participants enrolled.
• Results were posted on the registry 9 years 8 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 1, Phase 2

Sponsor

Hackensack Meridian Health

Sponsor type

University, hospital or other

Conditions

Graft Versus Host Disease

Interventions

Cyclophosphamide and Sirolimus; Low dose IL-2 with Cytoxan + Sirolimus; Low dose IL-2, low dose Vidaza, cyclophosphamide & Sirolimus; Cyclophosphamide and Sirolimus; Low dose IL-2 with Cytoxan + Sirolimus; Low dose IL-2, Vidaza, Cytoxan & Sirolimus

Participants

3

Sites

1

Countries

United States

Trials that died the same way

• A Phase I Trial Evaluating mFOLFOX6 and Avastin With Nexavar as First-Line Treatment for Metastatic Colorectal Cancer
  “Dose limiting toxicity at the lowest planned dose level.” (90% match in meaning)
• A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
  “Terminated due to dose limiting toxicity” (72% match in meaning)
• Total Therapy Study XIV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia
  “Toxicity” (69% match in meaning)
• A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
  “Extreme toxicity” (69% match in meaning)
• Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer
  “Inadequate toxicity” (66% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.