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Protocol # 21-113

Status

Recruiting

Description

This research is being done to assess the therapeutic activity of a promising combination (azacitidine and venetoclax) versus conventional cytotoxic chemotherapy in induction-eligible patients with acute myeloid leukemia. This study involves the following: - Venetoclax and azacitidine (investigational combination) - Cytarabine and idarubicin or daunorubicin (per standard of care) or Liposomal daunorubicin and cytarabine (per standard of care)

Condition

  • Acute Myeloid Leukemia

Interventions

  • Cytarabine
  • Idarubicin
  • Daunorubicin
  • Liposomal daunorubicin and cytarabine
  • Venetoclax
  • Azacitidine

Phase

Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Event free survival

Secondary Outcome:

  • Rate of response
  • Treatment-related toxicity
  • Rate of Minimal Residual Disease (MRD) negativity
  • 30-day mortality
  • 60-day mortality
  • Overall survival (OS)
  • Rate of stem cell transplantation (SCT) following induction
  • Patient reported quality of life (QOL)
  • Patient-reported depression symptoms
  • Patient-reported anxiety symptoms
  • Patient-reported symptom burden
  • Patient-reported post-traumatic stress symptoms
  • Health care utilization - hospitalizations
  • Health care utilization - days alive and out of the hospital
  • Health care utilization - Intensive care unit admissions
  • Cost of care
  • Incidence of neutropenic infections
  • 100-Day post-transplant mortality
  • Incidence of grade 3 or greater acute graft versus host disease (GVHD)

Enrollment

172

Study Start Date

May 20, 2021

Eligibility

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

Sponsors

Massachusetts General Hospital

Source

Massachusetts General Hospital

Official title

A Phase 2 Randomized Study Comparing Venetoclax and Azacitidine to Induction Chemotherapy for Newly Diagnosed Fit Adults With Acute Myeloid Leukemia

Clinicaltrials.gov Identifier

NCT04801797

     

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.