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Protocol No. NCI9924

Principal Investigator Fletcher, Christopher

Phase I

Age Group Adult

Scope National

Sponsor Type Externally Peer-Reviewed

Title A Phase I Trial of the Combination of Lenalidomide and Blinatumomab in Patients with Relapsed or Refractory Non-Hodgkins Lymphoma (NHL)

Objective The purpose of this study is to test the safety of Blinatumomab when combined with Lenalidomide at different dose levels. Blinatumomab is used to treat patients with B cell leukemia. There is data that it also helps patients with B cell lymphoma. Lenalidomide is FDA approved to use for patients with a specific subtype of lymphoma and a related cancer called multiple myeloma. Lenalidomide is believed to activate the immune system. Lenalidomide and Blinatumomab have never been used together which is why their use in this study is considered investigational. We want to find out what effects, good and/or bad, these two drugs, given together, have on you and your lymphoma.

Treatment All study participants will get the same study drugs. Different doses of the study drugs Lenalidomide and Blinatumomab will be given to several study participants. The starting dose of the drugs have been given to many other patients, but have never been given together. There will be 3-6 patients treated at each of the different doses. The first several study participants will receive the lowest dose. If the drug does not cause serious side effects, it will be given to other study participants at a higher dose. The doses will continue to increase for every group of study participants until side effects occur that require the dose to be lowered.

Description Blinatumomab is given by continuous infusion into a vein. The first 9 days it will be given in the hospital. Subsequent doses can be given at home by continuous infusion into a vein using a portable infusion pump. Lenalidomide is a capsule that you will take by mouth every day for three weeks every month in a 28 day cycle, with 7 days of rest.

Key Eligibility
  • Histologically or cytologically confirmed relapsed CD19+ NHL (included in this category are follicular grade I, II, III, marginal zone, mantle cell, gray zone, primary mediastinal, Burkitts, diffuse large B cell, small lymphocytic lymphoma
  • Age ≥18 years
  • ECOG performance status ≤2
  • Life expectancy of greater than 12 weeks
  • Patients must have had at least two prior chemotherapeutic or biologic (e.g., Rituximab alone) regimens and not currently eligible for standard curative options. Steroids alone and local radiation do not count as regimens
  • Any prior therapy must have been completed at least 4 weeks prior to entry into the study
  • Patients must have radiographically measurable disease
  • Females of childbearing potential must have a negative serum or urine pregnancy test
  • Patients with known brain metastases will be excluded
  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study
  • Patients with concurrent use of other anti-cancer agents or treatments are excluded
  • Patients with known active hepatitis, type B or C are excluded. Patients on suppressive therapy with a negative viral load and no evidence of hepatic damage are eligible
  • Patients with prior treatment with blinatumomab or CD-directed CAR T-cell therapy are excluded
  • Patients with prior treatment with lenalidomide within 8 weeks prior to entering the study are excluded

Applicable Disease Sites Lymphoma

Therapies Involved Immunotherapy

Drugs Involved Blinatumomab; CC-5013 (Lenalidomide); Lenalidomide; Revlimid (Lenalidomide)

Status Open

Participating Institutions UW Hospital and Clinics