Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia
Recruiting
Phase 1
Phase 2
Interventional Study
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
Burkitt-Like Lymphoma With 11q Aberration
High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
High Grade B-Cell Lymphoma, Not Otherwise Specified
Recurrent B Acute Lymphoblastic Leukemia
Recurrent Burkitt Lymphoma
Refractory B Acute Lymphoblastic Leukemia
Refractory Burkitt Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 276 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Other
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About This Trial
This phase I/II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating patients with acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Patients age 60 years or older with previously untreated ALL pre-B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL Minimal prior therapy (less than 1 week of steroids, vincristine, and/or 1 dose of anthracycline or alkylating agents) are allowed.
2. Patients unf…
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