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Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive PC Positive ALL and CML
Phase 1, PHASE2 trial testing Bosutinib in B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 in 22 participants. Completed in 23 March 2022.
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 16 April 2015 |
| Primary completion | 23 March 2022 |
| Estimated completion | 23 March 2022 |
| Sites | 1 location across United States |
M.D. Anderson Cancer Center — full company profile →
18 and older, any sex, with B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 or Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum tolerated dose of bosutinib defined as the highest dose level in which \< 2 patients of 6 develop first course dose limiting toxicity (Phase I). Dose levels assessed were dose 1 = 300 mg, dose 2 = 400 mg, and dose 3 = 500 mg.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 400 |
Major Hematologic Response i(MaHR) is defined as Complete Response (CR) + Complete Remission without Incomplete Blood Count Recovery (CRi). CR was defined as absence of circulating blasts with bone marrow blasts \<5% and recovery of neutrophil count to ≥1.0 x 10\^9/L and platelet count to ≥100 x10\^9/L. The CRi was defined as meeting criteria for CR except for neutrophil and/or platelet recovery. Response was assessed by bone marrow analysis after each cycle of therapy until attainment of CR/CRi.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 3 | |
| Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 | 4 | |
| Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 | 8 | |
| Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II | 4 |
Estimated using the method of Kaplan-Meier. Response date to loss of response or last follow up.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 4.1 | 1.9 – 8.8 |
| Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 | 7.7 | 6.2 – 73.8 |
| Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 | 27.2 | 2.1 – 68.9 |
| Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II | 5.1 | 0.7 – 8.1 |
Estimated using the method of Kaplan-Meier. Time from date of treatment start until date of death due to any cause or last Follow-up.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 | 8.2 | 6.8 – 10.7 |
| Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 | 9.6 | 2.0 – 74.6 |
| Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 | 47.5 | 2.7 – 72.8 |
| Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II | 5.3 | 2.0 – 28.2 |
Time frame: Up to 6 years, 11 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Bosutinib, Inot… | Treatment (Bosutinib, Inot… | Treatment (Bosutinib, Inot… | Treatment (Bosutinib, Inot… |
|---|---|---|---|---|---|
| Lung infection | Infections and infestations | — | — | — | — |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | — | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Abdominal pain | General disorders | — | — | — | — |
| Allergic reaction | Immune system disorders | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Dehydration | Gastrointestinal disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Encephalopathy | Nervous system disorders | — | — | — | — |
| Gastric hemorrhage | Gastrointestinal disorders | — | — | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — |
| Infections and infestations - Other, specify | Infections and infestations | — | — | — | — |
| Intracranial hemorrhage | Nervous system disorders | — | — | — | — |
| Non-cardiac chest pain | General disorders | — | — | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — | — | — |
| Upper respiratory infection | Infections and infestations | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Cardiac Arrest | Cardiac disorders | — | — | — | — |
| Reaction | System | Treatment (Bosutinib, Inot… | Treatment (Bosutinib, Inot… | Treatment (Bosutinib, Inot… | Treatment (Bosutinib, Inot… |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Edema limbs | General disorders | — | — | — | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — | — | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — |
| Alkaline phosphatase increased | Investigations | — | — | — | — |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Chest pain cardiac | Cardiac disorders | — | — | — | — |
| Confusion | Psychiatric disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Fever | General disorders | — | — | — | — |
| Headache | General disorders | — | — | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — | — | — |
| Lung infection | Infections and infestations | — | — | — | — |
| night sweats | General disorders | — | — | — | — |
| Pain | General disorders | — | — | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — |
| Rash maculo papular | Skin and subcutaneous tissue disorders | — | — | — | — |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — |
| Ataxia | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | — | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — | — |
| Blurred vision | Eye disorders | — | — | — | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Bruising | Injury, poisoning and procedural complications | — | — | — | — |
Most-reported serious reactions: Lung infection, Blood and lymphatic system disorders - Other, specify, Febrile neutropenia, Pleural effusion, Respiratory failure, Abdominal pain, Allergic reaction, Ascites.
Data from ClinicalTrials.gov NCT02311998 adverse events section.
This phase I/II trial studies the side effects and best dose of bosutinib when given together with inotuzumab ozogamicin and to see how well it works in treating patients with acute lymphoblastic leukemia or chronic myeloid leukemia that has come back or does not respond to treatment. Bosutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic substance and may help find cancer cells that express CD22 and kill them without harming normal cells. Giving bosutinib together with inotuzumab ozogamicin may be a better treatment for acute lymphoblastic leukemia or chronic myeloid leukemia.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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