Fludarabine / Total Body Irradiation Regimen for ALLO HCT in Acute Lymphoblastic Leukemia (FluTBI)

January 11, 2024 updated by: Omer Jamy, University of Alabama at Birmingham

Single Arm Phase II Study of Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia (ALL) in Older Patients Using Fludarabine and Total Body Irradiation (FluTBI) Regimen

The goal of this research is to test if the conditioning regimen, fludarabine and total body irradiation (FluTBI), can lead to a safer and more effective stem cell transplant treatment regimen for ALL patients older than 40 years of age and/or younger patients with high risk medical conditions. The primary objective is to establish the efficacy of allo HCT in older ALL patients using myeloablative FluTBI conditioning regimen. The investigators are also assessing the safety and toxicity of allo HCT in older ALL patients using myeloablative FluTBI conditioning regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • UAB Bone Marrow Transplantation and Cellular Therapy Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Disease Criteria:

    • ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration.
    • Philadelphia chromosome positive ALL is allowed.
    • Lymphoid blastic crisis of CML will be included (provided that patients achieve CR).
  • Age Criteria: Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen.
  • Organ Function Criteria: All organ function testing should be done within 28 days of study registration.
  • Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram.
  • Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted.
  • Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula:

CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL).

  • Hepatic:

    • Serum bilirubin 2.0 g/dL
    • Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN
    • Alkaline phosphatase 2.5 ULN
  • Performance status: Karnofsky ≥ 70%
  • Consent: Patient must be informed of the investigational nature of this study in accordance with institutional and federal guidelines and have the ability to provide written informed consent prior to initiation of any study-related procedures, and ability,in the opinion of the principal investigator, to comply with all the requirements of the study.
  • Presence of a willing adult HLA-matched sibling (excluding identical twin) or HLA-matched unrelated donor meeting all the criteria for routine allo HSCT. All donors will be evaluated for eligibility and suitability per the standard of care according to the FACT and NMDP guidelines.

Exclusion Criteria:

  • Non-compliant to medications.
  • No appropriate caregivers identified.
  • HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive
  • Active life-threatening cancer requiring treatment other than ALL
  • Uncontrolled medical or psychiatric disorders.
  • Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration.
  • Active central nervous system (CNS) leukemia
  • Preceding allogeneic HSCT
  • Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment
Fludarabine, Total Body Irradiation (TBI) Fludarabine: 40 mg/m2 X 4 days TBI: TBI 2 Gy 2 times a day X 3 days
Drug: Fludarabine
Procedure: Total Body Irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Disease-free Survival
Time Frame: 2 years post-transplant
Percentage of patients without relapse of disease at 2 years
2 years post-transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Regimen Related Toxicity
Time Frame: Within first 100 days post-transplant
Within first 100 days post-transplant
Number of Subjects With Platelet Engraftment
Time Frame: Within 100 days post transplant
Platelet engraftment is defined as the first of 3 consecutive days with a platelet count > 20,000/μL without platelet transfusion for 7 days.
Within 100 days post transplant
Percentage of Subjects That Survived
Time Frame: 2 years post-transplant
2 years post-transplant
Time to Neutrophil Engraftment
Time Frame: Within the first 100 days
Neutrophil engraftment is defined as the first of 3 consecutive days with an absolute neutrophil count (ANC) > 500/μL. Measuring the number of days it takes for (ANC) > 500/μL.
Within the first 100 days
Percentage of Subjects With Acute GVHD
Time Frame: 2 years post transplant
2 years post transplant
Number of Patients With Immune Reconstitution
Time Frame: 1 year post transplant
1 year post transplant
Percentage of Subjects With Relapse
Time Frame: 2 Years post-transplant
2 Years post-transplant
Percentage of Subjects With Chronic GVHD
Time Frame: 2 years post transplant
2 years post transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Omer H Jamy, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2013

Primary Completion (Actual)

January 30, 2020

Study Completion (Actual)

August 23, 2022

Study Registration Dates

First Submitted

September 29, 2013

First Submitted That Met QC Criteria

November 17, 2013

First Posted (Estimated)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAB 1285

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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