Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-04-30

Brief Summary

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The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission (CR1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell transplantation (SCT).

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Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Leukemia Stem Cells - Consolidation

Without LSC, standard cytarabine consolidation

Group Type EXPERIMENTAL

Cytarabine consolidation

Intervention Type DRUG

Cytarabine-based consolidation per institutional standards.

Leukemia Stem Cells - Consolidation

LSC present, randomized to cytarabine consolidation

Group Type EXPERIMENTAL

Cytarabine consolidation

Intervention Type DRUG

Cytarabine-based consolidation per institutional standards.

Leukemia Stem Cells - Transplant

LSC present, randomized to allogeneic transplant

Group Type EXPERIMENTAL

Allogeneic transplant

Intervention Type DRUG

Allogeneic stem cell transplant per institutional standards.

Interventions

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Cytarabine consolidation

Cytarabine-based consolidation per institutional standards.

Intervention Type DRUG

Allogeneic transplant

Allogeneic stem cell transplant per institutional standards.

Intervention Type DRUG

Other Intervention Names

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HiDAC Bone marrow transplant Stem cell transplant Hematopoietic stem cell transplant BMT HSCT

Eligibility Criteria

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Inclusion Criteria

1. Age greater than or equal to 18 years
2. Able to give informed consent
3. New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2

Exclusion Criteria

1. Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy
2. Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up
3. Pregnancy: Women of childbearing potential who are β- HCG+

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No