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

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. Identifier: NCT01991457
Recruitment Status : Recruiting
First Posted : November 25, 2013
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Ayman Saad, University of Alabama at Birmingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adult Lymphoblastic Lymphoma Drug: Fludarabine Procedure: Total Body Irradiation Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 2013
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Fludarabine, Total Body Irradiation (TBI)
Drug: Fludarabine
Procedure: Total Body Irradiation

Primary Outcome Measures :
  1. Number of subjects Disease-free survival [ Time Frame: 2 years post-transplant ]

Secondary Outcome Measures :
  1. Number of subjects that survived [ Time Frame: 2 years post-transplant ]
  2. Number of subjects with 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.

  3. Number of subjects with regimen related toxicity [ Time Frame: Within first 100 days post-transplant ]
  4. Number of subjects with Acute GVHD [ Time Frame: 2 years post transplant ]
  5. Mean rate of Immune Reconstitution [ Time Frame: 1 year post transplant ]
    Track the growth rate of and the number of lymphocyte subsets.

  6. Number of subjects with relapse [ Time Frame: 2 Years post-transplant ]
  7. 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.

  8. Number of subjects with chronic GVHD [ Time Frame: 2 years post transplant ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01991457

Contact: Tiffany D Hill, RN 205-996-8023

United States, Alabama
UAB Bone Marrow Transplantation and Cellular Therapy Program Recruiting
Birmingham, Alabama, United States, 35249
Contact: Tiffany D Hill, RN    205-996-8023   
Contact: Lindsey M Stephens, RN    205-975-2713   
Principal Investigator: Ayman A Saad, MD         
Sub-Investigator: Shin Mineishi, MD         
Sub-Investigator: Donna Salzman, MD         
Sub-Investigator: Racquel D Innis-Shelton, MD         
Sub-Investigator: Ruby Meredith, MD, PhD         
Sub-Investigator: Lawrence S Lamb, PhD         
Sub-Investigator: Antonio Di Stasi, MD         
Sub-Investigator: Luciano Costa, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
Principal Investigator: Ayman A Saad, MD University of Alabama at Birmingham

Additional Information:

Responsible Party: Ayman Saad, Associate Professor, University of Alabama at Birmingham Identifier: NCT01991457     History of Changes
Other Study ID Numbers: UAB 1285
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Ayman Saad, University of Alabama at Birmingham:

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents