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Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma
Phase 1, PHASE2 trial testing Autologous Hematopoietic Stem Cell Transplantation in Anaplastic Large Cell Lymphoma, ALK-Negative in 54 participants. Completed in 1 November 2020.
| Lead sponsor | University of Nebraska |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 28 September 2015 |
| Primary completion | 1 November 2019 |
| Estimated completion | 1 November 2020 |
| Sites | 8 locations across United States |
University of Nebraska
18 and older, any sex, with Anaplastic Large Cell Lymphoma, ALK-Negative or Anaplastic Large Cell Lymphoma, ALK-Positive. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I) within the first cycle of study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 10 |
Non-hematologic toxicities will be evaluated via the ordinal CTC standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by dose level and patient will be explored and summarized.
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Lenalidomide Participants | 5 | |
| 15 mg Lenalidomide Participants | 4 |
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Lenalidomide Participants | 3 | |
| 15 mg Lenalidomide Participants | 3 |
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Lenalidomide Participants | 2 | |
| 15 mg Lenalidomide Participants | 3 |
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Lenalidomide Participants | 4 | |
| 15 mg Lenalidomide Participants | 0 |
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Lenalidomide Participants | 0 | |
| 15 mg Lenalidomide Participants | 2 |
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Lenalidomide Participants | 0 | |
| 15 mg Lenalidomide Participants | 2 |
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Lenalidomide Participants | 0 | |
| 15 mg Lenalidomide Participants | 1 |
| Group | Value | 95% CI |
|---|---|---|
| 10 mg Lenalidomide Participants | 0 | |
| 15 mg Lenalidomide Participants | 1 |
A success is defined to be an objective status of CR after completion of 6 cycles of treatment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A 95% confidence interval for the true overall CR rate will be calculated according to the method of Duffy and Santner.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 49 | 33 – 64 |
The ORR will be estimated by the total number of patients who achieve a PR or CR at the end of six cycles of treatment divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true ORR will be calculated.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 69 | 54 – 81 |
The toxicity profile will be further assessed based on phase II patients. Overall toxicity incidence of maximum tolerated dose level of the Intent to treat (ITT) group of subjects is summarized. 39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 27 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 25 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 17 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 17 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 18 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 15 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 2 |
The distribution of overall survival will be estimated using the method of Kaplan-Meier.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 89 | 74 – 96 |
The distribution of PFS will be estimated using the method of Kaplan-Meier. The PFS rate at 2 years will be estimated. A 2-year PFS rate of 60% will be considered of interest.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Combination Chemotherapy, Lenalidomide) | 55 | 37 – 70 |
Time frame: Adverse events were collected from time of consent until 30 days post after the last administration of study drug (lenalidomide). For subjects going on to transplant after Len-CHOEP treatment this was approximately 5 months. For subjects going on the the maintenance len treatment instead of transplant upto an additional 1 year of maintenance lenalidomide treatment was allowed. (17 months total). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (10 mg Lenalidom… | Treatment (15 mg Lenalidom… |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| platelet count decreased | Blood and lymphatic system disorders | — | — |
| Neutrophil count decreased | Blood and lymphatic system disorders | — | — |
| fever | General disorders | — | — |
| anemia | Blood and lymphatic system disorders | — | — |
| sepsis | Infections and infestations | — | — |
| diarrhea | Gastrointestinal disorders | — | — |
| hypotension | Vascular disorders | — | — |
| pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| White blood cells decreased | Blood and lymphatic system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Appendicitis | Infections and infestations | — | — |
| back pain | Musculoskeletal and connective tissue disorders | — | — |
| Blood bilirubin increased | Investigations | — | — |
| cardiac arrest | Cardiac disorders | — | — |
| colitis | Gastrointestinal disorders | — | — |
| creatinine increased | Investigations | — | — |
| dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Enterocolitis | Gastrointestinal disorders | — | — |
| fatigue | General disorders | — | — |
| gastric hemorrhage | Gastrointestinal disorders | — | — |
| Ileus | Gastrointestinal disorders | — | — |
| Leukemia secondary to oncology chemotherapy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Lung infection | Infections and infestations | — | — |
| T3 ADRENAL CORTICAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Reaction | System | Treatment (10 mg Lenalidom… | Treatment (15 mg Lenalidom… |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| White blood cell decreased | Investigations | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| diarrhea | Gastrointestinal disorders | — | — |
| peripheral sensory neuropathy | Nervous system disorders | — | — |
| constipation | Gastrointestinal disorders | — | — |
| dizziness | Nervous system disorders | — | — |
| Anorexia | Gastrointestinal disorders | — | — |
| mucositis, oral | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| cough | Respiratory, thoracic and mediastinal disorders | — | — |
| hypotension | Vascular disorders | — | — |
| infections and infestation, Other | Infections and infestations | — | — |
| general disorders -Other | General disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| back pain | Musculoskeletal and connective tissue disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| dysgeusia | Nervous system disorders | — | — |
| dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| headache | Nervous system disorders | — | — |
| nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Other skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | — | — |
| weight loss | Investigations | — | — |
| chills | General disorders | — | — |
| fever | General disorders | — | — |
| other gastrointestinal disorders | Gastrointestinal disorders | — | — |
| malaise | General disorders | — | — |
| myalgia | Musculoskeletal and connective tissue disorders | — | — |
| neck pain | Musculoskeletal and connective tissue disorders | — | — |
| pain | General disorders | — | — |
| syncope | Nervous system disorders | — | — |
| Other blood and lymphatic disorders | Blood and lymphatic system disorders | — | — |
| dry eye | Eye disorders | — | — |
| dysphagia | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Febrile neutropenia, platelet count decreased, Neutrophil count decreased, fever, anemia, sepsis, diarrhea, hypotension.
Data from ClinicalTrials.gov NCT02561273 adverse events section.
This phase I/II trial studies the side effects and best dose of lenalidomide when given together with combination chemotherapy and to see how well they work in treating patients with newly diagnosed stage II-IV peripheral T-cell non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stop the growth of peripheral T-cell non-Hodgkin's lymphoma by blocking the growth of new blood vessels necessary for cancer growth. Giving combination chemotherapy with lenalidomide may be a better treatment for peripheral T-cell non-Hodgkin's lymphoma.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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