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Protocol # 20-191

Status

Recruiting

Description

This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it works for AML and MDS. A side effect is anything the drug does besides treating cancer. This study will have six groups or "parts." - Part A will find out how much SEA-CD70 should be given to patients. - Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat patients with MDS. - Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat patients with AML. - Part D will find out how much SEA-CD70 with azacitidine should be given to patients. - Part E will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat patients with MDS that has not been treated. - Part F will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat patients with MDS or AML.

Condition

  • Myelodyspastic Syndrome
  • Acute Myeloid Leukemia

Interventions

  • SEA-CD70
  • azacitidine

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Number of participants with adverse events (AEs)
  • Number of participants with laboratory abnormalities
  • Number of participants with a dose-limiting toxicity (DLT) at each dose level (Parts A and D only)

Secondary Outcome:

  • AUC - Area under the plasma concentration-time curve
  • Tmax - Time to maximum concentration attained
  • Cmax - Maximum observed plasma concentration
  • Ctrough - Minimum plasma concentration per dosing interval
  • T1/2 - Terminal elimination half-life
  • Incidence of antidrug antibodies (ADA)
  • Complete remission (CR) Rate
  • Complete remission with incomplete blood count recovery (CRi) rate
  • Complete remission with partial hematologic recovery (CRh) rate
  • Hematologic response (HI) rate
  • Overall response rate (ORR)
  • Blast clearance rate for participants with MDS
  • Duration of remission (DOR)
  • Overall survival (OS)
  • Event-free survival (EFS)
  • MRD-negative ORR
  • Time to response (TTR)
  • Rate of conversion to transfusion independence (TI)
  • Rate of TI maintenance

Enrollment

140

Study Start Date

August 7, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Seagen Inc.

Source

Seagen Inc.

Official title

A Phase 1 Study of SEA-CD70 in Myeloid Malignancies

Clinicaltrials.gov Identifier

NCT04227847

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.