Status:
COMPLETED
Phase II Trial of LMB-2, Fludarabine and Cyclophosphamide for Adult T-Cell Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult T-Cell Leukemia (ATL)
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
PHASE2
Brief Summary
BACKGROUND: * Cluster of differentiation 25 (CD25) (p55, Tac or interleukin 2 receptor (IL2R) alpha) is strongly expressed in virtually 100% of patients with adult T-cell leukemia/lymphoma (ATL), a h...
Detailed Description
BACKGROUND: * Cluster of differentiation 25 (CD25) (p55, Tac or interleukin receptor 2 (IL2Ra) is strongly expressed in virtually 100 % of patients with adult T-cell leukemia/lymphoma (ATL), a highly...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Diagnosis of acute or lymphomatous adult T-cell leukemia (ATL) by flow cytometry of blood or immunohistochemistry of biopsy tissue, confirmed by National Cancer Institute (NCI) Laboratory of Pathology, and previously treated unless the patient is ineligible for or refuses other protocols or treatments for ATL.
- Neutralizing antibodies less than or equal to 75% neutralization of 200 ng/ml of LMB-2.
- At least 18 years old.
- Eastern Cooperative Oncology Group (ECOG) 0-2.
- Able to understand and give informed consent.
- Negative pregnancy test for females of childbearing potential.
- The transaminases alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must each be less than or equal to 3-times the upper limits of normal (UNL) or less than or equal to 10-times normal if due to ATL. Albumin must be greater than or equal to 3.0 gm/dL. Total bilirubin must be less than or equal to 1.5 mg/dL except in patients with Gilberts syndrome (as defined by greater than 80 percent unconjugated bilirubin) it must be less than 5mg/dl.
- Creatinine less than 2.0 mg/dL.
- Absolute neutrophil count (ANC) greater than or equal to 1000/uL and platelets greater than or equal to 50,000/uL.
- Current or prior features of acute ( corrected calcium (Ca)++ \> 2.73 or lactate dehydrogenase (LDH) 2- fold above ULN) or chronic (LDH 1.5-2-fold above ULN or absolute lymphocyte count \>4 x10\^9/L with T-cells \>3.5 x10\^9/L) ATL. Patients with smoldering ATL (no acute or chronic features) and symptomatic ATL skin lesions are also eligible.
- EXCLUSION CRITERIA:
- Prior therapy with LMB-2.
- Central nervous system disease as evidenced by clinical symptomatology.
- Cytotoxic chemotherapy, steroids or monoclonal antibody (Mab) within 3 weeks of enrollment, except anti Tac Mab (i.e. daclizumab), which cannot be used within 12 weeks of enrollment. Hydroxyurea is considered different from cytotoxic chemotherapy and may be used up to the day before enrollment providing it is not increased during the week prior to enrollment and that patients disease burden is not decreasing during that time.
- Uncontrolled infection.
- Untreated or uncontrolled 2nd malignancy.
- Patients who are pregnant or breast-feeding.
- Patients who have human immunodeficiency virus (HIV) or hepatitis C, since in these patients reductions in normal T- or B-cells would increase the risk of exacerbation of their underlying disease. Patients would not be excluded for hepatitis B surface antigen positivity if on Lamivudine or Entecavir.
- Patients receiving warfarin (Coumadin \[R\])
- Patients with a left ventricular ejection fraction of less than 45%.
- Patients with a diffusing capacity of the lungs for carbon monoxide (DLCO) less than 50% of normal or an forced expiratory volume 1 (FEV1) less than 50% of normal.
- No concomitant use of alternative complimentary therapies or over the counter (OTC) agents allowed without prior approval of the principal investigator (PI).
- Tumor or lymph node masses \> 4 cm.
Exclusion
Key Trial Info
Start Date :
October 31 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00924170
Start Date
October 31 2008
End Date
May 5 2021
Last Update
November 14 2023
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892