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NCT01371630 · ClinicalTrials.gov registry record · Phase 1
Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia
A Phase 1 study of Recurrent B Acute Lymphoblastic Leukemia and High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 276
- Enrollment target
- 1
- Study location
NCT01371630 is a Phase 1 study of Recurrent B Acute Lymphoblastic Leukemia and High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 276 participants, above the 129-participant average among 12 other Recurrent B Acute Lymphoblastic Leukemia trials with a reported enrollment target (114% higher). The trial reports 1 study location across 1 state.
The verdict
NCT01371630, a Phase 1 study of Recurrent B Acute Lymphoblastic Leukemia and High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 276 participants
- Enrollment target
- 1
- Study location
Study Summary
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 to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Dexamethasone
- DRUG Cytarabine
- BIOLOGICAL Blinatumomab
- BIOLOGICAL Inotuzumab Ozogamicin
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2011-08-26 |
| Est. Completion | 2027-12-25 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01371630
The ClinicalTrials.gov registry entry for NCT01371630 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 129-participant average among 12 other Recurrent B Acute Lymphoblastic Leukemia trials with a reported enrollment target (114% higher). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Recurrent B Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01371630 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01371630 about?
NCT01371630 is a clinical study titled "Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia". 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 ...
What is the current status of trial NCT01371630?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 276 participants. The study started on 2011-08-26. Estimated completion is 2027-12-25.
What conditions does trial NCT01371630 study?
This clinical trial studies the following conditions: Recurrent B Acute Lymphoblastic Leukemia, High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements, B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, Refractory B Acute Lymphoblastic Leukemia, High Grade B-Cell Lymphoma, Not Otherwise Specified.
What interventions are being tested in trial NCT01371630?
The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG), Blinatumomab (BIOLOGICAL), Inotuzumab Ozogamicin (BIOLOGICAL).
Who is sponsoring clinical trial NCT01371630?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01371630 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Recurrent B Acute Lymphoblastic Leukemia
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High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.