Medical Access Program for Valemetostat Tosylate (DS 3201b) For The Treatment of Patients With Relapsed/Refractory (R/R) Peripheral T-cell Lymphoma (PTCL)

Sponsor: Daiichi Sankyo

Expanded Access
Sponsor score: 40

ClinicalTrials ID:NCT07862465

This Medical Access Program provides valemetostat tosylate to patients with relapsed/refractory PTCL who are ineligible for clinical trials. Treatment continues until disease progression, unacceptable toxicity, or other specified conditions occur. The starting dose is 200 mg daily in 28-day cycles. Eligibility criteria are not specified in the summary.

Patient Parameters

Program Overview

Valemetostat tosylate demonstrates antitumour activity in patients with peripheral T-cell lymphomas (PTCL) with a manageable safety profile. This Medical Access Program (MAP) offers an alternative treatment option for patients with PTCL who are ineligible for clinical trials by providing access to valmetostat tosylate, a medicinal product that has received marketing authorisation in Japan.

Description

A patient enrolled in the MAP can continue treatment until any of the following occurs, whichever comes first:

  • Disease progression.
  • Unacceptable toxicity.
  • The benefit-risk no longer favors the individual.
  • Valemetostat tosylate becomes commercially available in the US or other treatment options become available.
  • Withdrawal of consent to continue treatment.
  • Pregnancy.
  • Physician discretion.
  • Death.

Eligibility Criteria

Patients are only eligible after signing the Informed Consent Form (ICF) and must meet all of the following criteria to be eligible for the MAP:

  1. The patient is ≥18 years of age or the minimum legal adult age (whichever is greater) at the time the ICF is signed.

  2. The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

  3. The treating physician will confirm the following:

    1. Patients with the indicated subtypes of PTCL are eligible, according to 2016 World Health Organization classification prior to receiving the first dose of valemetostat tosylate.

    2. The patient must have at least 2 prior lines of systemic therapy for PTCL or ATLL. Patients with ALCL must have prior brentuximab vedotin treatment.

    3. The patient has an adequate organ function with hepatic and renal function laboratory parameters as specified in the protocol.

    4. The patient has an adequate bone marrow function.

    5. Female patients of childbearing potential agree to use highly effective, low user dependence contraception methods and refrain from donating eggs during treatment and for 3 months after the last dose.

      Note: Monthly at-home pregnancy testing recommended after the last dose of valemetostat tosylate and for 3 months

    6. Male patients capable of producing sperm agree to use highly effective with low user dependence contraception methods and refrain from donating sperm during treatment and for 3 months after the last dose.

Patients who meet any of the following criteria will not be eligible for the MAP:

  1. The patient is eligible and can participate in a clinical trial involving an investigational medicine that may potentially treat the condition (s) indicated in this program and/or the patient may be treated and benefit from approved drugs available for the treatment of the condition(s) indicated in this program.
  2. The patient has a diagnosis of mycosis fungoides, Sézary syndrome, and primary cutaneous ALCL and systemic dissemination of primary cutaneous ALCL.
  3. The patient has a diagnosis of precursor T-cell leukemia and lymphoma (T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma), T-cell prolymphocytic leukemia, or T-cell large granular lymphocytic leukemia.
  4. The patient has undergone a transplant and has not yet recovered, as determined at the discretion of the treating HCP.
  5. The patient has an uncontrolled or significant cardiovascular disease.
  6. Patients who are pregnant or breastfeeding or intend to become pregnant during the program.
  7. The patient shows evidence of ongoing uncontrolled acute systemic bacterial, fungal, or viral infection i.e. HIV, Hepatitis B&C requiring systemic therapy.
  8. The patient has any active uncontrolled systemic diseases or other medical conditions considered to be poorly controlled by the healthcare provider, including, but not limited to, bleeding diatheses.
  9. The patient has a known or suspected hypersensitivity to valemetostat tosylate or any of the excipients.

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