Lenalidomide and Gemcitabine in Relapsed or Refractory Peripheral T-cell Lymphomas

NCT05105412 | Terminated Phase 1 DMC

• 1 other identifier: T1421
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 5

Brief Summary

This is a single country multi-center, open-label phase Ib/II single-arm study in relapsed or refractory PTCL patients. Patients will be treated with the combination of lenalidomide and gemcitabine until disease progression, intolerable toxicity, or patient withdrawal.

Conditions

Peripheral T-cell Lymphomas (PTCL)

Keywords

peripheral T-cell lymphomas (PTCL)

Outcome Measures

Primary Outcomes (2)

• DLT

  To evaluate the dose-limited toxicity (DLT) of combination of lenalidomide and gemcitabine

  12 months

• ORR

  To evaluate the objective response rate of combination of lenalidomide and gemcitabine by Lugano classification

  24 months

Secondary Outcomes (3)

• PFS

  24months

• OS

  24months

• Treatment-related adverse events

  24months

Study Arms (1)

Lenalidomide and Gemcitabine

EXPERIMENTAL

Lenalidomide and Gemcitabine

Drug: Lenalidomide and Gemcitabine (Dose level 11); Drug: Lenalidomide and Gemcitabine (Dose level 21); Drug: Lenalidomide and Gemcitabine (Dose level 31); Drug: Lenalidomide and Gemcitabine (Dose level 41)

Interventions

Lenalidomide and Gemcitabine (Dose level 11) DRUG

lenalidomide 25 mg/day D1-D14 and gemcitabine 1000 mg/m2 D1, D8

Also known as: Dose level 11

Lenalidomide and Gemcitabine

Lenalidomide and Gemcitabine (Dose level 21) DRUG

lenalidomide 15 mg/day D1-D14 and gemcitabine 1000 mg/m2 D1, D8

Also known as: Dose level 21

Lenalidomide and Gemcitabine

Lenalidomide and Gemcitabine (Dose level 31) DRUG

lenalidomide 10 mg/day D1-D14 and gemcitabine 1000 mg/m2 D1, D8

Also known as: Dose level 31

Lenalidomide and Gemcitabine

Lenalidomide and Gemcitabine (Dose level 41) DRUG

lenalidomide 10 mg/day D1-D14 and gemcitabine 800 mg/m2 D1, D8

Also known as: Dose level 41

Lenalidomide and Gemcitabine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adult patients (20 years of age) have the following three subtypes of PTCL:
• (1)Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), (2)Angioimmunoblastic lymphoma (AITL), or (3)Anaplastic large cell lymphoma (ALCL). If patients had CD30-positive systemic ALCL, they should receive brentuximab vedotin before enrollment 2. (1) In transplant-eligible patients: patients who have relapsed disease after autologous stem-cell transplantation (2) In transplant-ineligible patients: patients who have received at least first-line systemic chemotherapy treatment and have a stable disease, progressive disease, or relapsed disease.
• \. Patients have an ECOG Scale of Performance Status score of 0-1. 4. Patients have at least one measurable lesion by CT with a size of \> 1.5 cm in at least one axis.
• \. Patients have adequate renal function: serum creatinine (Cr) ≤ 1.5 times the upper limit of normal range (ULN) and calculated creatinine clearance (Ccr) ≥ 40 mL/min.
• \. Patients have adequate bone marrow function:
• Absolute neutrophil count (ANC) ≥ 1500/μL, Without growth factor support (filgrastim or lenograstim) for at least 14 days
• Platelet count ≥ 75 000/μL. Evaluated at least 7 days after last platelet transfusion
• Hemoglobin ≥ 8 g/dL. May receive transfusion 7. Patients have adequate hepatic function: serum alkaline phosphatase (ALP), alanine, or aspartate aminotransferase levels (ALT \& AST) ≤ 2.5 times the ULN and serum total bilirubin ≤ 1.5 times the ULN.

You may not qualify if:

• Patients have already been exposed to lenalidomide and gemcitabine.
• Patients have less than 100 days from previous autologous stem cells transplantation prior to first study drug dose.
• Patients have HIV infection.
• Patients have cerebral or meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy.
• Patients have symptomatic neurologic disease compromising normal activities of daily living or requiring medication.
• Patients have any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose.
• Patients received prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy (eg, immunoglobulin replacement, other monoclonal antibody therapies) within 4 weeks of first study drug dose.
• Patients have known hypersensitivity to any excipient contained in the drug formulation of lenalidomide or gemcitabine.
• Patients have known positive hepatitis B surface antigen but not receive anti-hepatitis B drug, or known or suspected active hepatitis B and C infection.
• Patients have diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
• Patients have any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
• A left-ventricular ejection fraction \<50%.
• Myocardial infarction within 2 years of randomization.
• New York Heart Association (NYHA) Class III or IV heart failure
• Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• National Taiwan University Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator
• China Medical University Hospital: collaborator

Study Sites (5)

Chang-Gung Memorial Hospital, Kaohsiung

Kaohsiung City, Taiwan

Location

National Cheng-Kung University Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

National Taiwan University Cancer Center

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Lenalidomide; Gemcitabine

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines

Study Officials

• Tsang-Wu Liu

  Taiwan Cooperative Oncology Group, NHRI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 3, 2021
• Study Start: June 15, 2022
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-06

Locations

TW (5)