NCT03902769

Brief Summary

We previously reported results of a prospective observational study demonstrating that early response defined as reduction in bone marrow (BM) blast counts to less than 5% of BM cells by the fifth day of induction therapy is a strong predictor of remission and overall survival (Ofran Y, et al. AJH, 2015). The long term survival benefit of early response was confirmed later on after a median follow-up for surviving patients of 53 months (range 17.5-84.5).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

April 15, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

2.6 years

First QC Date

April 2, 2019

Last Update Submit

April 4, 2019

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Event free survival

    Two years

Secondary Outcomes (1)

  • Overall survivial

    two years

Study Arms (2)

No allogeneic SCT

EXPERIMENTAL

For standard or intermediate risk AML patients who achieved good rapid response, allogenic SCT will be excluded from treatment plan

Procedure: Prescribing conventional chemotherapy while with holding allo-SCT

Standard post induction therapy

ACTIVE COMPARATOR

For slow responding AML patients, post induction therapy will be provided according to treating physician discretion

Procedure: Prescribing conventional chemotherapy while with holding allo-SCT

Interventions

Prescribing conventional chemotherapy while with holding allo-SCTPROCEDURE

Prescribing conventional chemotherapy (chemotherapy consolidations or autologous SCT) while with holding allo-SCT

Also known as: No Allogeneic for rapid responders
No allogeneic SCTStandard post induction therapy

Eligibility Criteria

Age18 Years - 61 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • AML diagnosis,
  • treated with 3+7 Induction chemotherapy
  • Intermediate/standard risk AML

You may not qualify if:

  • Diagnosed of APL
  • high risk molecular/cytogenetic score

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Yishai Ofran, MD

CONTACT

+972-4-7778026y_ofran@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: One arm open study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of leukemia Service

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 4, 2019

Study Start

April 15, 2019

Primary Completion

November 1, 2021

Study Completion

November 1, 2023

Last Updated

April 8, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share