Phase 2
N=59
Lenalidomide Therapy After Chemotherapy & Stem Cell Transplant in Treating Chemotherapy Resistan Non-Hodgkin Lymphoma
Anaplastic Large Cell Lymphoma, ALK-Negative · Recurrent Anaplastic Large Cell Lymphoma · Recurrent Mantle Cell Lymphoma · Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma · Recurrent Non-Hodgkin Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01035463 ↗Enrolled (actual)
59
Serious AEs
25.4%
Results posted
Nov 2019
Primary outcome: Primary: Maximum Tolerated Dose of Lenalidomide (Phase I) — 10 milligrams PO daily
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Autologous Hematopoietic Stem Cell Transplantation (Procedure); Carmustine (Drug); Cytarabine (Drug); Etoposide (Drug); Lenalidomide (Drug); Melphalan (Drug); Rituximab (Biological)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose of Lenalidomide (Phase I) |
10 | — |
| SECONDARY Event-free Survival |
84; 87 | — |
| SECONDARY Overall Survival |
100; 95 | — |
Summary
This phase I/II trial studies the side effects and best dose of lenalidomide when given after combination chemotherapy with or without rituximab and stem cell transplant and to see how well it works in treating patients with non-Hodgkin lymphoma that has not responded to treatment or has returned after a period of improvement and is resistant to chemotherapy. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as carmustine, etoposide, cytarabine, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, may block cancer growth by targeting certain cells. Giving lenalidomide after combination chemotherapy with or without rituximab may work better in treating patients with non-Hodgkin lymphoma.
Eligibility Criteria
Inclusion Criteria
- Persistent, or relapsed non-Hodgkin's lymphoma (NHL) (any histology) that is chemo-resistant ( = 3 prior chemotherapy regimens, or subjects with lymphomas that have a high relapse rate following autologous or syngeneic stem cell transplantation (transformed NHL, peripheral T-cell lymphoma [PTCL], mantle cell lymphoma, anaplastic lymphoma kinase [ALK]-negative anaplastic large cell lymphoma [ALCL, alk neg]), intermediate International Prognostic Index (IPI) or high risk IPI or subjects with a positive positron emission tomography (PET) scan prior to transplant, and otherwise eligible for transplantation with adequate end-organ function
- Subjects that relapse within one year of diagnosis
- Able to collect >= 1.5 x 10^6 CD34+/kg cell for transplantation
- Absolute neutrophil count (ANC) >= 1000 cells/mm^3 and platelet count >= 60 K when maintenance lenalidomide is started (day 100 post-transplant)
- Subjects must have calculated creatinine clearance >= 30 ml/min
- Total bilirubin = = six months
- Karnofsky performance status >= 70
- Subjects > age 60 or with clinical signs of heart disease must have ejection fraction >= 45% left ventricular ejection fraction (LVEF) pre-transplant
- Subjects with clinical signs of pulmonary insufficiency must have diffusion capacity of the lung for carbon monoxide (DLCO) to be measured at >= 50% of predicted value
- No serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study
- Disease free of prior malignancies for >= 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast or low risk prostate cancer after curative therapy
- All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of Revlimid REMS program
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, as least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (subjects intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin)
- Male subject agrees to use an acceptable method for contraception for the duration of the study
Exclusion Criteria
- Chemosensitive NHL, except subjects receiving >= 3 prior chemotherapy regimens, or subjects having transformed NHL, PTCL, mantle cell lymphoma (MCL) or ALCL, alk neg
- End-organ function not appropriate for transplantation
- Inability to collect adequate stem cells
- Known positive for human immunodeficiency virus (HIV) or infectious hepatitis, type B (HBV) or C (HCV) or active hepatitis
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
- Pregnant or breast feeding females; (lactating females must agree not to breast feed while taking lenalidomide)
- Known hypersensitivity to thalidomide or lenalidomide (if applicable)
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
- Any prior use of lenalidomide
- Concurrent use of other
Data sourced from ClinicalTrials.gov (NCT01035463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.