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Inotuzumab Ozogamicin

Bosutinib

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Tyrosine

Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Patients receive bosutinib at the Maximum Tolerated Dose from the Phase I dose part, PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Nitin Jain

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.

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study and whether or not you have received earlier treatment for leukemia. Up to 36 participants will be enrolled in Part 1 of the study, and up to 44 participants will be enrolled in Part 2.

If you are enrolled in Part 2, you will receive bosutinib at the highest dose that was tolerated in Part 1. All participants in Parts 1 and 2 will receive the same dose of inotuzumab ozogamicin.

Study Drug Administration. You will take bosutinib tablets by mouth 1 time each day with food. If you miss or vomit a dose of bosutinib, do not take "make up" the dose. Wait and take your next dose as scheduled the next day.

You will also receive inotuzumab ozogamicin by vein over about 1 hour on Days 1, 8, and 15 of each 28-day cycle. If the doctor thinks it is needed, you may switch to a different dosing schedule and receive inotuzumab ozogamicin 1 time every 4 weeks.

You will be given standard drugs (such as acetaminophen/paracetamol, antihistamines, and/or steroids) to help decrease the risk of side effects. If your doctor thinks it is needed, you may also receive hydroxyurea to control your white blood cell count while you are on study. You may ask the study staff for information about how these drugs are given and their risks.

Follow-Up After your end-of-treatment visit or call, you will be called 1 time about every 12 weeks (for up to 1 year) and asked about any anti-cancer therapy you may have started. This call will last about 5 minutes.

After completion of study treatment, patients are followed up every 12 weeks for up to 1 year.

Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive PC Positive ALL and CML

A Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-Positive Philadelphia-Chromosome Positive Acute Lymphoblastic Leukemia and Chronic Myeloid Leukemia Lymphoid Blast Phase

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.

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.

Estimated using the method of Kaplan-Meier. Response date to loss of response or last follow up.

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.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Bosutinib: Given PO 300mg

Inotuzumab Ozogamicin: Given IV

Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1

Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Bosutinib: Given PO 400mg

Inotuzumab Ozogamicin: Given IV

Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2

Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Bosutinib: Given PO 500mg

Inotuzumab Ozogamicin: Given IV

Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3

Patients receive bosutinib at the Maximum Tolerated Dose from the Phase I dose part, PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Bosutinib: Given PO

Inotuzumab Ozogamicin: Given IV

Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Nitin Jain MD/Associate Professor

This outcome is only intended for the Phase I arm of this study

Maximum Tolerated Dose (MTD) of Bosutinib All Phase I Participants

Number of Participants With a Major Hematologic Response

Of the 18 participants treated during Phase I, 15 were evaluable for response.

Duration of Response

Overall Survival (OS)

Overall Study

Epratuzumab

Cysteine

Patients receive ADCT-602 by vein over 30 minutes on day 1. Courses repeat every 21 in the absence of disease progression or unacceptable toxicity. Patients who achieve CR/CRi receive ADCT-602 every 28 days.

Starting dose of ADCT-602: 30 μg/kg given by vein.

ADCT-602

Ibrahim Aldoss, MD

This phase I/II trial studies the side effects and best dose of ADCT-602 in treating patients with B-cell lymphoblastic leukemia that has come back or does not respond to treatment. Monoclonal antibodies, such as ADCT-602, may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVES:

I. Evaluate the safety and determine the maximum tolerated dose (MTD) of ADCT-602 in patients with relapsed or refractory B-cell (B)-acute lymphoblastic leukemia (ALL) in Phase 1.

II. Determine the recommended dose of ADCT-602 for Phase 2. III. Evaluate the efficacy (complete response \[CR\] with incomplete marrow recovery \[CR/CRi\] rate) of ADCT-602 in Phase 2.

SECONDARY OBJECTIVES:

I. Evaluate the clinical activity of ADCT-602, based on duration of response (DOR), overall survival (OS), and progression-free survival (PFS).

II. Characterize the pharmacokinetic (PK) profile of ADCT-602. III. Evaluate the immunogenicity of ADCT-602. IV. Characterize the effect of ADCT-602 exposure on the QT interval.

EXPLORATORY OBJECTIVES:

I. Obtain preliminary data on the correlation between the clinical activity and PK profile of ADCT-602 with the baseline expression of CD22 and other cluster of differentiation (CD) markers in peripheral blood.

II. Assess the impact of soluble CD22 (sCD22) on ADCT-602 PK.

OUTLINE: This is a dose escalation study followed by a phase II study.

Patients receive ADCT-602 intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 in the absence of disease progression or unacceptable toxicity. Patients who achieve CR/CRi receive ADCT-602 every 28 days.

After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for up to 1 year.

ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia

A Phase I/II Study to Evaluate the Safety and Anti-Tumor Activity of ADCT-602 Targeting CD22 in Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

The MTD is the highest dose level in which the study has treated 6 patients with at most 1 experiencing the DLT. The 3+3 algorithm along with DLTs observed during the first 21 days of the first treatment cycle will be used to guide dose escalation/de-escalation.

The recommended dose of ADCT-602 for phase 2 is the MTD or a dose lower than MTD, which is defined based on toxicity and efficacy profile.

Simon's two-stage design will be used. CR/CRi rate is defined as the best response (CR/CRi) noted during the study period.

Blood for testing the amount of ADCT-602 in the body at different time points drawn 4 times over the 6 hours after the dose.

ADC Therapeutics S.A.

Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles.

Elias Jabbour

This phase II trial studies how well inotuzumab ozogamicin works in treating patients with CD22 positive acute lymphoblastic leukemia that has come back or does not respond to treatment. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.

PRIMARY OBJECTIVES:

I. To evaluate the objective response rate of low dose of inotuzumab ozogamicin as measured by the hematologic remission rate (complete remission \[CR\] + CR with incomplete platelet recovery \[CRp\] + CR with incomplete bone marrow recovery \[CRi\]) in patients in first, second or later salvage setting.

SECONDARY OBJECTIVES:

I. To evaluate the overall safety profile and the efficacy; the efficacy is measured by the hematologic response rate (CR + CRi + PR), durations of response (DoR) and remission (DoR1), progression free survival (PFS), and overall survival (OS).

OUTLINE:

Patients receive inotuzumab ozogamicin intravenously (IV) over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles.

Inotuzumab Ozogamicin in Treating Patients With Relapsed or Refractory CD22 Positive Acute Lymphoblastic Leukemia

Phase II Study of Low Dose Inotuzumab Ozogamicin in Patients With Relapsed and Refractory CD22 Positive Acute Lymphocytic Leukemia

Complete Remission (CR) is the normalization of the peripheral blood and bone marrow with \</= 5% blasts with a granulocyte count of 1X10\^9/L or above and a platelet count of \>/= 100X10\^9/L and absence of extramedullary disease.

For the purpose of toxicity monitoring, toxicities are defined as any treatment -related grade 3 or 4 non-hematologic AEs occurred any time during the trial.NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 utilized for adverse event reporting.

The date of Complete Response to the date of loss of response or last follow-up.

Time from date of treatment start until the date of first objective documentation of disease-relapse.

Time from date of treatment start until date of death due to any cause or last Follow-up.

Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles.

Inotuzumab Ozogamicin: Given IV

Treatment (Inotuzumab Ozogamicin)

Elias Jabbour, MD./ Professor, Leukemia

Number of Participants to Achieve Complete Remission (CR)

Participants With a Grade 3 or 4 Non-hematologic Adverse Event (AE)

Progression Free Survival

Overall Survival

Lymphoma, B-Cell

B-cell Lymphoma

Sirolimus

Temsirolimus

MTOR Inhibitors

Immunosuppressive Agents

Clotrimazole

Miconazole

Antifungal Agents

starting dose 0.8 mg/m2, d1 administration, q4wks

starting dose of 15mg, weekly administration, q4ws

Anastasios Stathis, Dr.

This is an open label phase I study of Inotuzumab Ozogamicin, an antibody-targeted intravenous chemotherapy agent composed of a CD22-targeted antibody linked to calicheamicin, in combination with the mammalian target of rapamycin (mTOR) inhibitor Temsirolimus, in patients with relapsed/refractory CD22+ B-cell non Hodgkin's lymphomas (NHLs). Both Inotuzumab Ozogamicin and Temsirolimus have been evaluated as single agents as well as in combination with rituximab in patients with NHLs. This is the first study combining the two agents together. In the present study Inotuzumab Ozogamicin will be administered intravenously on d1 at the starting dose of 0.8 /m2. Temsirolimus will be administered intravenously on days 1,8,15 and 22 at the starting dose of 15mg. Cycles will be repeated every 28 days.

Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma

A Phase I Study of Inotuzumab Ozogamicin (CMC-544) in Combination With Temsirolimus (CCI-779) in Patients With Relapsed or Refractory CD22-positive B-cell Non Hodgkin's Lymphomas

To determine the safety profile, establish the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of Inotuzumab Ozogamicin in combination with Temsirolimus in patients with relapsed/refractory CD22+ B-cell NHLs

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive PC Positive ALL and CML	NCT02311998	B Acute Lymphob... Blast Phase Chr... Blasts More Tha... CD22 Positive Philadelphia Ch... Recurrent Chron... Refractory Chro...	Bosutinib Inotuzumab Ozog...	18 Years -	M.D. Anderson Cancer Center
Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive PC Positive ALL and CML	NCT02311998	B Acute Lymphob... Blast Phase Chr... Blasts More Tha... CD22 Positive Philadelphia Ch... Recurrent Chron... Refractory Chro...	Bosutinib Inotuzumab Ozog...	18 Years -	M.D. Anderson Cancer Center
ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia	NCT03698552	Blasts 5 Percen... CD22 Positive Philadelphia Ch... Recurrent B Acu... Refractory B Ac...	ADCT-602	18 Years -	M.D. Anderson Cancer Center
Inotuzumab Ozogamicin in Treating Patients With Relapsed or Refractory CD22 Positive Acute Lymphoblastic Leukemia	NCT03094611	CD22 Positive Recurrent Acute... Refractory Acut...	Inotuzumab Ozog...	12 Years -	M.D. Anderson Cancer Center
Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma	NCT01535989	B-cell Lymphoma...	Inotuzumab Ozog... Temsirolimus	18 Years -	Oncology Institute of Southern Switzerland

Spots Global Cancer Trial Database for cd22 positive