New approaches for treating relapsed T-cell leukemia

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

This study is testing new treatment options for patients with relapsed T-cell leukemia by looking at their genetic information to find the best therapy for them.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 10 sites (Ancona and 9 other locations)
• Trial ID: NCT04582487 on ClinicalTrials.gov

What this trial studies

This study focuses on patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and early T-cell acute lymphoblastic leukemia (ETP-ALL). It involves collecting bone marrow and peripheral blood samples to perform genomic profiling and phosphoproteomic screening, aiming to identify new therapeutic options based on molecular data. Once the profiling results are available, local investigators can request the clinical use of identified compounds. Patients will receive treatment tailored to their molecular profile, alongside supportive care as needed.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with relapsed or refractory T-ALL or ETP-ALL who have not achieved complete remission after initial therapy.

Not a fit: Patients with T-ALL/LBL who are in complete remission or those with CNS 3 disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatments for patients with relapsed T-ALL and ETP-ALL.

How similar studies have performed: Other studies have shown promise in using genomic profiling for targeted therapies in leukemia, suggesting potential success for this approach.

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%

Where this trial is running

Ancona and 9 other locations

• Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica — Ancona, Italy (Recruiting)
• Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia — Bergamo, Italy (Recruiting)
• Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia — Bologna, Italy (Recruiting)
• Asst Degli Spedali Civili Di Brescia - Uo Ematologia — Brescia, Italy (Recruiting)
• Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia — Lecce, Italy (Recruiting)
• Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia — Mestre, Italy (Recruiting)
• Ematologia ed Immunologia Clinica — Perugia, Italy (Recruiting)
• Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica — Roma, Italy (Recruiting)
• Aou Senese - Uoc Ematologia E Trapianti — Siena, Italy (Recruiting)
• Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia — Vicenza, Italy (Recruiting)

Study contacts

• Study coordinator: Paola Fazi

Conditions T Acute Lymphoblastic Leukemia; Early T Acute Lymphoblastic Leukemia; T-lymphoblastic Lymphoma; Etp All