Inotuzumab Ozogamicin for Leukemia, Lymphocytic, Acute, L1

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Brigham and Women's Hospital, Boston, MA
Leukemia, Lymphocytic, Acute, L1+6 More
Inotuzumab Ozogamicin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating the safety and efficacy of administering venetoclax and inotuzumab ozogamicin in combination in patients with acute lymphoblastic leukemia (ALL)

See full description

Eligible Conditions

  • Leukemia, Lymphocytic, Acute, L1
  • B-cell Acute Lymphoblastic Leukemia
  • B Cell Lymphoma (BCL)
  • ALL

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Leukemia, Lymphocytic, Acute, L1

Study Objectives

This trial is evaluating whether Inotuzumab Ozogamicin will improve 1 primary outcome and 5 secondary outcomes in patients with Leukemia, Lymphocytic, Acute, L1. Measurement will happen over the course of Enrollment to end of treatment up to 9 months.

Month 9
Disease-free survival (DFS)
Event-free survival (EFS)
Maximum tolerated dose of venetoclax in combination with inotuzumab ozogamicin
Measurable residual disease (MRD)-response
Morphologic response
Overall survival (OS).

Trial Safety

Safety Progress

1 of 3

Other trials for Leukemia, Lymphocytic, Acute, L1

Trial Design

1 Treatment Group

Venetoclax + Inotuzumab Ozogamicin with Dexamethasone
1 of 1
Experimental Treatment

This trial requires 26 total participants across 1 different treatment group

This trial involves a single treatment. Inotuzumab Ozogamicin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Venetoclax + Inotuzumab Ozogamicin with DexamethasonePhased 28 day treatment cycles with lead in: Lead In Cycle: Dose escalated venetoclax 1x daily for days 1-3 with and Dexamethasone daily for days 1-3 lead in, 7 days total. Induction Cycle 1: Dose escalated venetoclax 1x daily for days 1-21, Dexamethasone daily for days 1-4, Inotuzumab ozogamicin on days 1, 8, and 15 Induction Cycle 2: Dose escalated venetoclax 1x daily for days and Inotuzumab ozogamicin on days 1, 8, and 15 Consolidation Cycles: Up to 5 cycles of dose escalated Venetoclax 1x daily for days and Inotuzumab ozogamicin on days 1, 8, and 15
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved
Dexamethasone
FDA approved
Inotuzumab ozogamicin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: enrollment to end of treatment up to 9 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly enrollment to end of treatment up to 9 months for reporting.

Who is running the study

Principal Investigator
M. R. L.
Marlise R. Luskin, Principal Investigator
Dana-Farber Cancer Institute

Closest Location

Brigham and Women's Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia, Lymphocytic, Acute, L1 or one of the other 6 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
CD22 must be detected on ≥ 20% of lymphoblasts by flow cytometry of peripheral blood, flow cytometry of bone marrow aspirate or tissue biopsy, or immunohistochemistry of the bone marrow or tissue biopsy in order to make a diagnosis of ALL. show original
Philadelphia-chromosome positive B-ALL patients who have received prior treatment with a TKI medication are eligible for this therapy without receiving additional cytotoxic chemotherapy, as long as they are not eligible for standard cytotoxic chemotherapy. show original
People with chronic myeloid leukemia who are in a lymphoid blast crisis are eligible to participate in this study, but they must have been resistant to two or more TKIs (tyrosine kinase inhibitors) or resistant to ponatinib. show original
The patient has a hematologic disorder with ≥ 5% lymphoblasts in the diagnostic sample. show original
People must be at least 18 years old to participate. show original
People with B-LBL are eligible to participate in the study if they meet other eligibility criteria. show original
People in the study must have a disease that has come back or hasn't responded to one or more rounds of chemotherapy. show original
Participants must have a cancer that is confirmed by a biopsy to have the CD22 protein on their B cells. show original
Philadelphia-chromosome positive B-ALL participants are eligible, but must be resistant to at least two different tyrosine kinase inhibitors (TKIs) or resistant to the drug ponatinib. show original
Inotuzumab ozogamicin is not allowed as a Prior Therapy. show original

Patient Q&A Section

What does inotuzumab ozogamicin usually treat?

"Patients whose tumors have a chromosomal abnormality called 13q14, a translocation involving chromosome 13, often develop CLL after a year from therapy. Inotuzumab ozogamicin is used to treat these patients because this type of chromosomal abnormality does not appear to be responsive to conventional chemotherapy, due to its lack of activity against B cells. However, when patients have 13q14 abnormalities, they almost always respond to inotuzumab ozogamicin. It is therefore important to know whether a patient has 13q14 before starting personalized therapy with inotuzumab ozogamicin." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving inotuzumab ozogamicin?

"The current data suggest that this regimen is active in patients with B-NHL. However, further study is required to evaluate its utility in elderly patients with CLL or SLL, and to establish its role in MCL." - Anonymous Online Contributor

Unverified Answer

Is inotuzumab ozogamicin typically used in combination with any other treatments?

"The majority of patients treated with iota alone experienced an overall response rate of >25%, including responders whose disease had not responded to previous treatments. A trend toward improved outcomes was observed in patients receiving iota plus paclitaxel over those receiving iota alone. Iota monotherapy should be considered in refractory/ relapsed follicular lymphoma." - Anonymous Online Contributor

Unverified Answer

How quickly does lymphoma, b-cell spread?

"They usually begin within 2 years after their initial diagnosis (mean 8.7 months). For patients who present with bulky lymphoma (>10 cm dilation), they are more likely to have advanced stage disease at presentation (stage 3 or 4) than those presenting with nonbulky lymphoma (<10 cm dilation). Patients with a history of AIDS were more likely to have advanced lymphoma stage at presentation." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets lymphoma, b-cell?

"Because lymphomas are generally diagnosed at a younger age than cancers, we estimated the average age of diagnosis for lymphoma as 48 years. When comparing the mean age of diagnosis with the mean age of death, we found that the average age of dying was 65 years. These data provide some insight into the demographics of lymphoma. With the exception of HL, the number of cases of each type of lymphoma increases with increasing age." - Anonymous Online Contributor

Unverified Answer

Has inotuzumab ozogamicin proven to be more effective than a placebo?

"Inotuzumab ozogamicin was shown to have superior efficacy compared to a placebo for patients with refractory B-cell lymphoma. Furthermore, this study demonstrated that combination of inotuzumab ozogamicin and rituximab showed similar superiority to inotuzumab ozogamicin alone. This trial demonstrates that inotuzumab ozogamicin is a promising drug candidate for treatment of B-cell lymphoma, and further studies are required to evaluate its most appropriate use." - Anonymous Online Contributor

Unverified Answer

Is inotuzumab ozogamicin safe for people?

"Inotuzumab ozogamicin was well tolerated and associated with high response rates in patients with relapsed or refractory B-cell lymphomas, particularly in elderly patients. The overall survival rate was comparable to previous studies of this agent." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating lymphoma, b-cell?

"There have not been any significant new treatments for lymphoma, b-cell. Only one newer drug, rituximab, has shown promise in treatment. Rituximab is an immunosuppressive drug that specifically targets B cells. It was originally used for chronic lymphocytic leukemia (CLL) but has also seen success against follicular lymphoma and diffuse large B cell lymphoma. Rituximab has shown some promise in treating relapsed or refractory follicular lymphoma." - Anonymous Online Contributor

Unverified Answer

How many people get lymphoma, b-cell a year in the United States?

"The number of patients with lymphoma, B-cell a year in the US was estimated at 53,000, based on the data from the SEER database. This means that 1 in 48 Americans (19%) will get lymphoma, B-cell a year. These numbers do not take into account age or sex." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for lymphoma, b-cell?

"Clinical trial enrollment was higher among patients with primary cHL than those without cHL. The reasons for this remain unclear but may reflect current practice patterns. This finding may motivate more patients with cHL to enroll in clinical trials." - Anonymous Online Contributor

Unverified Answer

What is lymphoma, b-cell?

"Lymphoma, B cell, is a rare disease with various manifestations. With appropriate management, patients can achieve excellent outcomes; however, the prognosis of untreated patients is poor. Lymphoma, B cell, is a heterogenous disease with a wide variety of morphologies and patterns of expression of molecular markers." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Leukemia, Lymphocytic, Acute, L1 by sharing your contact details with the study coordinator.