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Ofatumumab and Fresh Frozen Plasma in Patients With Chronic Lymphocytic Lymphoma
Phase 2 trial testing Ofatumumab + Fresh Frozen Plasma in Chronic Lymphocytic Leukemia in 12 participants. Completed in 1 October 2020.
| Lead sponsor | Joseph Tuscano |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 14 January 2013 |
| Primary completion | 1 October 2019 |
| Estimated completion | 1 October 2020 |
| Sites | 1 location across United States |
Joseph Tuscano — full company profile →
18 and older, any sex, with Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Defined as complete, or partial response, and progression-free survival. Measured by National Cancer Institute - Working Group and International Workshop on Chronic Lymphocytic Leukemia
| Group | Value | 95% CI |
|---|---|---|
| Ofatumumab + Fresh Frozen Plasma | 10 | |
| Ofatumumab + Fresh Frozen Plasma | 2 |
Toxicities will be graded according to the NCI CTCAE v4.0.
| Group | Value | 95% CI |
|---|---|---|
| Ofatumumab + Fresh Frozen Plasma | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Ofatumumab + Fresh Frozen Plasma | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Ofatumumab + Fresh Frozen Plasma | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Ofatumumab + Fresh Frozen Plasma | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Ofatumumab + Fresh Frozen Plasma | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Ofatumumab + Fresh Frozen Plasma | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Ofatumumab + Fresh Frozen Plasma | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Ofatumumab + Fresh Frozen Plasma | 1 |
Count of participants known to be alive up to two years from the time from start of treatment.
| Group | Value | 95% CI |
|---|---|---|
| Ofatumumab + Fresh Frozen Plasma | 11 |
Complement CH50 is a blood test that helps us determine whether protein abnormalities and deficiencies in the complement system are responsible for any increase in autoimmune activity.
| Group | Value | 95% CI |
|---|---|---|
| Ofatumumab + Fresh Frozen Plasma | 54 | 20 – 100 |
Time frame: Up to 2 years.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Ofatumumab + Fresh Frozen … |
|---|---|---|
| Lung infection | Infections and infestations | — |
| Atrial fibrillation | Cardiac disorders | — |
| Reaction | System | Ofatumumab + Fresh Frozen … |
|---|---|---|
| Infusion related reaction | Injury, poisoning and procedural complications | — |
| Anemia | Blood and lymphatic system disorders | — |
| Fatigue | General disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Allergic reaction | Immune system disorders | — |
| Headache | Nervous system disorders | — |
| Neutrophil count decreased | Investigations | — |
| Platelet count decreased | Investigations | — |
| Skin infection | Infections and infestations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| White blood cell decreased | Investigations | — |
| Creatinine increased | Investigations | — |
| Dizziness | Nervous system disorders | — |
| Hypertension | Vascular disorders | — |
| Insomnia | Psychiatric disorders | — |
| Lymphocyte count increased | Investigations | — |
| Sinusitis | Infections and infestations | — |
| Anxiety | Psychiatric disorders | — |
| Blood bilirubin increased | Investigations | — |
| Chills | General disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Dyspspsia | Gastrointestinal disorders | — |
| Blepharitis | Eye disorders | — |
| Flushing | Vascular disorders | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — |
| Feverish | General disorders | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — |
| Hiccups | Respiratory, thoracic and mediastinal disorders | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Lymph node pain | Blood and lymphatic system disorders | — |
| Palpitations | Cardiac disorders | — |
| Paresthesia | Nervous system disorders | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Rash acneform | Skin and subcutaneous tissue disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Lung infection, Atrial fibrillation.
Data from ClinicalTrials.gov NCT01716208 adverse events section.
It has been shown that many patients with lymphoma or chronic lymphocytic leukemia (CLL)have low levels of complement. Several drugs have been approved by the Food and Drug Administration (FDA) for use in this cancer. However, these drugs are often used as combination therapies which means two or more drugs are part of the treatment. Many people, especially elderly patients, cannot put up with the use of multiple drugs because of the side effects. The main purpose of this study is to see if patients respond to therapy with human plasma (known as fresh frozen plasma or FFP) and ofatumumab. Another purpose of the study is to find out if this therapy will increase chances of getting rid of leukemia. This study will also look at the levels of complement in your blood. The levels of complement may allow better understanding of whether increasing the levels of complement by giving FFP may help control leukemia.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01716208.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing