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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: Recruiting 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.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined as non-hematologic grade 3 or 4 toxicities during the first course. Toxicities will be monitored using the method of Thall, Simon, and Estey. Adverse events will be summarized and toxicity rate will be estimated with a 90% credible interval.
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 |
What NCT01371630 shows while recruiting
NCT01371630 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, above the 129-participant average among 12 other Recurrent B Acute Lymphoblastic Leukemia trials with a reported enrollment target (114% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Recurrent B Acute Lymphoblastic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01371630's enrollment target sits among peer trials
276 3rd of 12 higher than 10 of 12 other Recurrent B Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent B Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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