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

Phase 2

Completed

• Conditions: Adult Lymphoblastic Lymphoma
• Interventions: Drug: Fludarabine; Procedure: Total Body Irradiation

• Registration Number: NCT01991457
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-08-27
• Study First Submitted: 2013-09-29
• Study First Submitted QC: 2013-11-17
• Study First Posted: 2013-11-25
• Primary Completion: 2020-01-30
• Study Completion: 2022-08-23
• Results First Submitted: 2022-08-23
• Results First Submitted QC: 2022-08-23
• Results First Posted: 2022-09-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Disease-free Survival	2 years post-transplant	Percentage of patients without relapse of disease at 2 years

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects That Survived	2 years post-transplant
Number of Subjects With Regimen Related Toxicity	Within first 100 days post-transplant
Percentage of Subjects With Acute GVHD	2 years post transplant
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.
Percentage of Subjects With Chronic GVHD	2 years post transplant
Time to 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. Measuring the number of days it takes for (ANC) \> 500/μL.
Number of Patients With Immune Reconstitution	1 year post transplant
Percentage of Subjects With Relapse	2 Years post-transplant

Trial Locations

Locations (1)

UAB Bone Marrow Transplantation and Cellular Therapy Program; 🇺🇸 Birmingham, Alabama, United States