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Immunotherapy for Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Blast Phase Chronic Myelogenous Leukemia (BP CML), and Myelodysplastic Syndrome (MDS) Relapse After Allogeneic Transplantation | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Immunotherapy for Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Blast Phase Chronic Myelogenous Leukemia (BP CML), and Myelodysplastic Syndrome (MDS) Relapse After Allogeneic Transplantation

A Pilot Phase II Study of Immunotherapy for the Treatment of AML, ALL, BP CML, and MDS Relapsed After Allogeneic Transplantation

NCT00548847•Emory University

View on ClinicalTrials.gov

Summary

The relapse of acute leukemia, MDS and blast phase CML after allogeneic transplantation affects approximately 1/3 to 1/2 of all transplant recipients and is the main cause of treatment failure. There is currently no effective standard treatment for this condition. This study will test the activity and feasibility of using a regimen to boost the immune system in order to treat AML, ALL, blast phase CML, and MDS relapse after allogeneic transplantation.

Detailed Description

This is a pilot phase II open label study testing the activity and feasibility of utilizing a regimen to boost the immune system in order to treat AML, ALL, blast phase CML, and MDS relapse after allogeneic transplantation. The regimen is a step-wise use of withdrawal of immunosuppression, cytoreduction if needed, administration of granulocyte-macrophage colony-stimulating factor (GM-CSF) and pegylated interferon (IFN) α-2b to patients who relapsed after an allogeneic transplant and will assess efficacy. Relapse is the major problem following allogeneic hematopoietic progenitor cell transplants. There is currently no standard way to treat leukemia that relapsed after transplant, and patients have a poor prognosis. A retrospective analysis of patients treated at Emory showed that administration of GM-CSF and interferon-alpha-2b was well-tolerated and affected long-term remissions in a small number of relapsed patients (after allogeneic transplant). Pre-clinical and clinical data from ours and other centers showed that relapsed leukemic blasts have down-regulation of co-stimulatory molecules and a tendency to evade the immune system. Cytokines can up-regulate co-stimulatory molecules on leukemic blasts and have been shown to increase the cytotoxicity of T-cells. This effect may be beneficial as a graft vs. leukemia effect for patients with relapse after allogeneic transplant.

Eligibility

Age

1 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age \> 1 year.
•2. Patients who have received an allogeneic transplant to treat AML, ALL, MDS, or CML and have relapse or progression of their AML, ALL, MDS, or CML are eligible to participate in the study. Relapse is defined as: reappearance of leukemic blasts as determined by morphologic analysis of the blood or marrow, reappearance of a phenotypic population of leukemia blasts by flow cytometric analysis of the blood or marrow, reappearance of a chromosome abnormality which is associated with the original leukemia as determined by chromosomal or fluorescence in situ hybridization (FISH) testing (ex: a translocation between chromosomes 9 and 22 for CML), reappearance of the molecular marker which is associated with the original leukemia as determined by polymerase chain reaction (PCR) (ex: breakpoint cluster region \[BCR\]-Abelson murine leukemia \[ABL\] for CML or ALL).
•\*Patients who received allogeneic transplantation to treat AML, ALL, MDS, or CML with detectable disease, and did not achieve remission of their leukemia after transplant are eligible.
•3. Eastern Cooperative Oncology Group (ECOG) performance status \< 2 for adults, and Lansky status 60% for children.
•4. Liver functions tests (aspartate transaminase \[AST\]/alanine aminotransferase \[ALT\]/bilirubin) \< 5x the upper limit of normal.
•5. Creatinine \< 3x the upper limit of normal.
•6. Lack of active grade 2-4 acute graft-versus-host disease (GVHD) 3 weeks after discontinuation of immunosuppression.
•7. Patients with limited stage and extensive stage chronic GVHD of mild severity (lichenoid changes), or requiring \< prednisone 10 mg/m² daily will be included.
•8. Recipients of grafts procured from related and unrelated donors with any level of human leukocyte antigen (HLA)-matching.

Exclusion Criteria

•1. Pregnant patients are excluded due to unknown risk to the unborn fetus with cytokines.
•2. Allergy to components of interferon-alpha-2b or GM-CSF.
•3. Current uncontrolled infection.
•4. Current grade 2-4 acute GVHD or chronic extensive GVHD of moderate to severe nature, requiring treatment with more than 10 mg/m² of prednisone daily.
•5. Uncompensated heart failure, New York Heart Association (NYHA) class III-IV:
•* Class I: patients with no limitation of activities; they suffer no symptoms from ordinary activities;
•* Class II: patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion;
•* Class III: patients with marked limitation of activity; they are comfortable only at rest;
•* Class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest.
•6. Breast feeding, due to unknown risk to the infant.
+2 more criteria

Locations (1)

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Key Dates

Start Date

January 1, 2007

Primary Completion Date

March 1, 2015

Completion Date

March 1, 2015

Last Updated

October 26, 2016

Enrollment

ACTUAL participants

Conditions

Leukemia

Interventions

GM-CSF

BIOLOGICAL

Interferon-α-2b

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Immunotherapy for Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Blast Phase Chronic Myelogenous Leukemia (BP CML), and Myelodysplastic Syndrome (MDS) Relapse After Allogeneic Transplantation

Inclusion Criteria

Exclusion Criteria

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients