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Study to Assess Length of Remission With Intensive Chemotherapy in Rapidly Responding AML Patients. (AML)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902769
Recruitment Status : Not yet recruiting
First Posted : April 4, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Yishai Ofran, Rambam Health Care Campus

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).

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Procedure: Prescribing conventional chemotherapy while with holding allo-SCT Not Applicable

Detailed Description:
Patients diagnosed with AML, younger than 61 year of age assigned for intensive chemotherapy, and diagnosed with standard or intermediate risk AML, will undergo BM examination on the fifth day of induction. Patients in whom BM blast count at the fifth day of induction will be lower than 5% will proceed therapy with consolidations or autologous SCT with-holding the option for allo-SCT. MRD monitoring will apply to those with reliable molecular marker.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: One arm open study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Prospective Study to Assess Rate for Prolonged Remission With Intensive Chemotherapy in Rapid Respondents AML Patients Younger Than 61 as Demonstrated by Day 5 Examination of the First Treatment.
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2023


Arm Intervention/treatment
Experimental: No allogeneic SCT
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
Prescribing conventional chemotherapy (chemotherapy consolidations or autologous SCT) while with holding allo-SCT
Other Name: No Allogeneic for rapid responders

Active Comparator: Standard post induction therapy
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
Prescribing conventional chemotherapy (chemotherapy consolidations or autologous SCT) while with holding allo-SCT
Other Name: No Allogeneic for rapid responders




Primary Outcome Measures :
  1. Event free survival [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. Overall survivial [ Time Frame: two years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Diagnosed of APL
  • high risk molecular/cytogenetic score

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902769


Contacts
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Contact: Yishai Ofran, MD +972-4-7778026 y_ofran@rambam.health.gov.il

Sponsors and Collaborators
Rambam Health Care Campus
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Responsible Party: Dr. Yishai Ofran, Director of leukemia Service, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03902769    
Other Study ID Numbers: RMB-250-18
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No