TSALV: Advanced Chemotherapy Treatment for Relapsed Leukemia or Lymphoma in Children

A Phase II Study Incorporating Panobinostat, Bortezomib, and Liposomal Vincristine into Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma

Category:

Leukemia / Lymphoma

Diseases Treated:

Leukemia, Lymphoma

Eligibility Overview:

  • T-call acute lymphoblastic leukemia or lymphoma that has:
    • Come back after treatment the first time or
    • Did not respond to treatment the first time
  • 21 years or younger
  • Able to swallow capsules
  1. Brief Summary

    This is a phase-II study to evaluate the efficacy of a salvage regimen in children with relapsed T-cell acute lymphoblastic leukemia or lymphoma. Most patients with this disease severity have a poor prognosis, even when treated with intensive salvage chemotherapy and hematopoietic stem cell transplantation.

    Peg-asparaginase, mitoxantrone, intrathecal triples (IT) (intrathecal methotrexate/hydrocortisone/ cytarabine) (ITMHA) and dexamethasone are commonly used drugs to treat relapsed or refractory ALL or lymphoma. This study will add to this combination regimen three additional drugs: panobinostat, bortezomib and liposomal vincristine (VSLI).

    Panobinostat has been approved by the FDA for treating adults with multiple myeloma but it has not been approved for use in children and has not been given together with the other drugs used in this study. It has not been widely studied in children. VSLI has been approved by the FDA for adults with relapsed or refractory ALL, but has not yet been approved for treating children with leukemia or lymphoma. Bortezomib has been approved by the FDA for treating adults with a cancer called multiple myeloma and adults with relapsed mantle cell lymphoma; it has not been approved for treating children.

    Primary Objectives

    • To estimate the complete remission rate for patients with T-cell lymphoblastic leukemia and lymphoma in first relapse.

    Secondary Objectives

    • To evaluate minimal residual disease levels at end of each block of therapy.
    • To describe the toxicities of vincristine sulfate liposome injection when used in combination with chemotherapy and bortezomib.

    Eligibility Criteria

    Inclusion Criteria include:

    • Diagnosis of relapsed or refractory acute lymphoblastic leukemia or lymphoma
    • 21 years or younger
    • Able to swallow capsules
    • Karnofsky or Lansky performance score is ≥ 60%.

    Exclusion Criteria include:

    • Prior histone deaceytylases (HDAC), DAC, HSP90 inhibitors or valproic acid for treatment of cancer
    • Need for valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment
    • Impaired cardiac function or clinically significant cardiac diseases
    • Impairment of gastrointestinal function
    • Major surgery ≤ 4 weeks prior to starting treatment or unrecovered from side effects of such therapy
    • Positive for human immunodeficiency virus or hepatitis B/C.

    Study Design

    Open label, Phase II

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

  2. About this study

    This study will test a new drug combination to see if it can treat cancer that has come back after treatment or that has not improved with treatment.

    Acute lymphoblastic leukemia (ALL) is the most common type of childhood cancer. Children with ALL don’t have enough normal white blood cells so their body has a hard time fighting infections. Standard treatment for ALL may include chemotherapy, radiation and stem cell transplant. Most children respond well to standard treatment, but others may have cancer that comes back or does not respond to treatment at all.

    This study will test a combination chemotherapy that includes three new drugs: panobinostat, bortezomib and liposomal vincristine (VSLI). The U.S. Food and Drug Administration (FDA) has approved these drugs to treat certain cancers in adults. The drugs have not been approved to treat leukemia or lymphoma in children.

    Purpose of this study

    Researchers want to know if adding panobinostat, bortezomib and liposomal vincristine to standard chemotherapy drugs will treat ALL and lymphoma in children successfully when the disease has come back or not responded to earlier treatment. They also want to know how the body processes these drugs. The goal is to improve testing and treatments for these diseases.

    Eligibility overview

    • T-call acute lymphoblastic leukemia or lymphoma that has:
      • Come back after treatment the first time or
      • Did not respond to treatment the first time
    • 21 years or younger
    • Able to swallow capsules
  3. TSALV Quick View
    Sponsor St. Jude Children’s Research Hospital 
    Clinicaltrials.gov identifier NCT02518750
    Trial start date December 2015
    Estimated enrollment 40
    Study type Interventional
    Study Phase Phase II
    Conditions

    Leukemia, Lymphoma

    Ages 21 and under
    Principal investigator Sima Jeha, MD
    Study site St. Jude Children’s Research Hospital
    For a consultation or to discuss TSALV St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Sima Jeha, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org