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CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma
Phase 2 trial testing CPI 613 in Relapsed T-Cell Lymphoma in 6 participants. Terminated before completion.
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 16 September 2020 |
| Primary completion | 21 April 2023 |
| Estimated completion | 11 July 2024 |
| Sites | 1 location across United States |
Wake Forest University Health Sciences
18 and older, any sex, with Relapsed T-Cell Lymphoma or Refractory T-Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of patients successfully able to complete 80% (at least 5 of 6 planned cycles) of their therapy regimens.
| Group | Value | 95% CI |
|---|---|---|
| CPI-613 in Combination With Bendamustine | 3 |
Overall response rate is defined as the proportion of patients who achieve a best overall response complete response or partial response during or following study treatment. Response derived from the Lugano classification for PTCL patients and Global Response Score for CTCL (MF/SS) patients. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: The Lugano classification.
| Group | Value | 95% CI |
|---|---|---|
| CPI-613 in Combination With Bendamustine | 1 |
Disease control rate defined as the proportion of patients who achieve a best overall response of complete response, partial response, or stable disease (SD). Best overall response of stable disease must have met the response stable disease criteria at least once ≥12 weeks after start of study treatment. Response derived from the Lugano classification for PTCL patients and Global Response Score for CTCL (MF/SS) patients
| Group | Value | 95% CI |
|---|---|---|
| CPI-613 in Combination With Bendamustine | 3 |
Duration of Response will be defined for responders (patients with a best overall response of complete response or partial response). It is the time from the date of the first documented complete response or partial response until the date of the first date of progressive disease, or death due to any cause, whichever occurs first. If a patient has not progressed or died by the analysis cutoff date, duration of response will be censored at the time of the last adequate tumor assessment on or before the cutoff date. Response derived from the Lugano classification for PTCL patients and Global Re
| Group | Value | 95% CI |
|---|---|---|
| CPI-613 in Combination With Bendamustine | 2.3 | 2.3 – 2.3 |
Progression free survival defined as the time from the start of study treatment until the first date of progressive disease, or death due to any cause, whichever occurs first. If a patient has not progressed or died by the analysis cutoff date, progression free survival will be censored at the time of the last adequate tumor assessment on or before the cutoff date. Response derived from the Lugano classification for PTCL patients and Global Response Score for CTCL (MF/SS) patients
| Group | Value | 95% CI |
|---|---|---|
| CPI-613 in Combination With Bendamustine | 2.7 | 2.1 – 6.1 |
Overall survival is measured from the start of study treatment until death due to any cause. If a patient is not known to have died at the date of the analysis cut-off, overall survival will be censored at the last date that: Patient is documented to be alive. At the time of single cell sequencing.
| Group | Value | 95% CI |
|---|---|---|
| CPI-613 in Combination With Bendamustine | 7.5 | 6.5 – 17.1 |
Time frame: Adverse events are monitored from the start of treatment until 30 days after last treatment dose. Average of 7.8 months with range of 16.6 months. The timeframe for all cause mortality is longer and has a maximum observed follow-up of 3 years 9 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | CPI-613 in Combination Wit… |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Infections and infestations - Other: Catheter related infection | Infections and infestations | — |
| Sepsis | Infections and infestations | — |
| Skin infection | Infections and infestations | — |
| Upper respiratory infection | Infections and infestations | — |
| Neutrophil count decreased | Investigations | — |
| Platelet count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Reaction | System | CPI-613 in Combination Wit… |
|---|---|---|
| Diarrhea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Anemia | Blood and lymphatic system disorders | — |
| Edema limbs | General disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Blood bilirubin increased | Investigations | — |
| Neutrophil count decreased | Investigations | — |
| Platelet count decreased | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Pain | General disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Alkaline phosphatase increased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Blood lactate dehydrogenase increased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Dysgeusia | Nervous system disorders | — |
| Insomnia | Psychiatric disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Cardiac disorders - Other: BASELINE MURMUR | Cardiac disorders | — |
| Palpitations | Cardiac disorders | — |
| Ear pain | Ear and labyrinth disorders | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Chills | General disorders | — |
| Fever | General disorders | — |
| Bacteremia | Infections and infestations | — |
| Infections and infestations - Other: FUNGAL POSITIVE SPUTUM | Infections and infestations | — |
| Infections and infestations - Other: INCREASED MONOCYTES | Infections and infestations | — |
Most-reported serious reactions: Anemia, Infections and infestations - Other: Catheter related infection, Sepsis, Skin infection, Upper respiratory infection, Neutrophil count decreased, Platelet count decreased, White blood cell decreased.
Data from ClinicalTrials.gov NCT04217317 adverse events section.
The purpose of this study is to determine if it is possible to give CPI-613 with the drug Bendamustine for 2 days every 28 days without causing severe side effects. In addition, this study will also test the safety of CPI-613 when given in combination with Bendamustine.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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