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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01991457
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
124.1
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
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 :
Aug 27, 2013
Anticipated Primary Completion Date :
Dec 28, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Treatment

Fludarabine, Total Body Irradiation (TBI)

Drug: Fludarabine

Procedure: Total Body Irradiation

Outcome Measures

Primary Outcome Measures

  1. Number of subjects Disease-free survival [2 years post-transplant]

Secondary Outcome Measures

  1. Number of subjects that survived [2 years post-transplant]

  2. Number of subjects with neutrophil engraftment [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 [Within first 100 days post-transplant]

  4. Number of subjects with Acute GVHD [2 years post transplant]

  5. Mean rate of Immune Reconstitution [1 year post transplant]

    Track the growth rate of and the number of lymphocyte subsets.

  6. Number of subjects with relapse [2 Years post-transplant]

  7. Number of subjects with platelet engraftment [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 [2 years post transplant]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UAB Bone Marrow Transplantation and Cellular Therapy Program Birmingham Alabama United States 35249

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

  • Principal Investigator: Donna E Salzman, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Omer Jamy, Primary Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01991457
Other Study ID Numbers:
  • UAB 1285
First Posted:
Nov 25, 2013
Last Update Posted:
Apr 19, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Keywords provided by Omer Jamy, Primary Investigator, University of Alabama at Birmingham
ALL
Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Fludarabine

Study Results

No Results Posted as of Apr 19, 2022