Advancing Chemical and Genomic Strategies for Relapsed/Refractory T-ALL and ETP-ALL

Launched by GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO · Oct 6, 2020

Keywords

ClinConnect Summary

This clinical trial is looking into new ways to treat patients with certain types of T-cell blood cancers, specifically T Acute Lymphoblastic Leukemia (T-ALL) and Early T Acute Lymphoblastic Leukemia (ETP-ALL). The study involves collecting blood and bone marrow samples to analyze their genetic makeup. By understanding the unique characteristics of each patient's cancer, researchers hope to find new treatment options that are better suited to individual needs. This trial is currently recruiting patients who are over 18 years old and have had limited success with previous treatments.

To be eligible for this study, patients must have a specific type of T-cell leukemia or lymphoma that has relapsed (come back) or not responded to initial treatment. They should have a certain level of cancer cells in their blood or bone marrow and meet other health criteria to ensure their safety during the trial. Participants will work closely with their healthcare team, and as new potential treatments are identified from the tests, there may be opportunities to use these treatments in their care. It's important for anyone considering joining this trial to discuss it with their doctor to fully understand its risks and benefits.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients to be enrolled in this study must have T-cell ALL or T-cell lymphoblastic lymphoma (LL) in the first relapse or must have failed primary induction chemotherapy (i.e., never attained a complete remission following an initial course of standard therapy for T-ALL/LBL or have a diagnosis of ETP-ALL \[T-ALL with the following phenotype: Negative: CD1a-, CD8-, CD4-, CD5 (less than 75% of blasts); CD13+, CD33+, CD34+, CD117+, HLA-DR+, CD11b+, and/or CD65+ -in at least 25% of lymphoblasts
• • Ages Eligible for Study: over 18 years
• • Patients with T-ALL/LBL must have greater than 5% blasts in the bone marrow with or without extramedullary disease
• • Patients with T-ALL/LBL must have recurrent disease, documented by clinical or radiographic criteria, as well as histologic verification of the malignancy at original diagnosis
• • Patients may have CNS 1 (WBC count in CSF \<5 and having no blasts) or CNS 2 (WBC count in CSF \<5 and having blasts) disease but not CNS 3 (WBC count in CSF ≥5 and having blasts)
• • ECOG 0-2 or Karnofsky ≥ 50%
• • Patients may be enrolled on study regardless of the timing of prior Intrathecal therapy; however, they may not begin treatment on this protocol until a minimum of 7 days has elapsed since prior intrathecal therapy
• • Adequate renal function defined as serum creatinine ≤ 1.5x upper limit of normal (ULN) for age. If the serum creatinine is above these values, the calculated creatinine clearance or radioisotope GFR must be ≥ 70 mL/min/1.73m2
• • Total bilirubin ≤ 1.5x ULN for age. If the total bilirubin is elevated, patient will still be eligible if the conjugated (direct) serum bilirubin ≤ ULN for age
• • ALT ≤ 5x ULN of normal for age
• • Adequate cardiac function defined as shortening fraction of ≥ 27% by echocardiogram or ejection fraction ≥ 45% by gated radionuclide study
• • No evidence of dyspnea at rest
• • No exercise intolerance
• • A pulse oximetry ≥ 94% at sea level (≥ 90% at altitude ≥ 5000 feet) if there is clinical indication for determination
• • Patients must be capable of understanding the investigational nature, potential risks and benefits of the study. All patients must sign a written informed consent
• Exclusion Criteria:
• • Significant organ compromise that will increase risk of toxicity or mortality
• • Active serious infection not controlled by oral or intravenous antibiotics
• • Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year
• • Known hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)
• • Active grade III-V cardiac failure as defined by the New York Heart Association Criteria
• • Patients with a cardiac ejection fraction (as measured by either multigated acquisition \[MUGA\] or echocardiogram) \< 40%