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NCT01822509 · ClinicalTrials.gov registry record · Phase 1

Ipilimumab or Nivolumab in Treating Patients With Relapsed Hematologic Malignancies After Donor Stem Cell Transplant

A Phase 1 study of Recurrent Acute Myeloid Leukemia and Myeloproliferative Neoplasm, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
71
Enrollment target
13
Study locations

NCT01822509: Completed Phase 1 study of Recurrent Acute Myeloid Leukemia and Myeloproliferative Neoplasm, sponsored by National Cancer Institute (NCI).

NCT01822509 is a Phase 1 study of Recurrent Acute Myeloid Leukemia and Myeloproliferative Neoplasm that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 71 participants, above the 57-participant average among 57 other Recurrent Acute Myeloid Leukemia trials with a reported enrollment target (25% higher). The trial reports 13 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01822509, a Phase 1 study of Recurrent Acute Myeloid Leukemia and Myeloproliferative Neoplasm, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
71 participants
Enrollment target
13
Study locations

Study Summary

This phase I/Ib trial studies the side effects and best dose of ipilimumab or nivolumab in treating patients with cancers of the blood and blood-forming tissues (hematologic cancers) that have returned after a period of improvement (relapsed) after donor stem cell transplant. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Primary Outcome

Dose-limiting toxic (DLT) effects were defined as grade III or IV acute graft versus host disease (GVHD), grade 4 hematologic toxic effects unrelated to the underlying disease, or grade 3 nonhematologic toxic effects that did not improve to grade 1 with a 3-week dose delay. Immune-related adverse events that resolved to grade 1 or lower with the use of glucocorticoids were not considered to be dose-limiting toxic effects. We designated the observation period for toxic effects to be 12 weeks to c

Conditions Studied

Recurrent Acute Myeloid Leukemia Myeloproliferative Neoplasm Recurrent Chronic Lymphocytic Leukemia Recurrent Myelodysplastic Syndrome Recurrent Acute Lymphoblastic Leukemia Recurrent Non-Hodgkin Lymphoma Recurrent Hodgkin Lymphoma Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive Allogeneic Hematopoietic Stem Cell Transplant Recipient Recurrent Hematologic Malignancy

Interventions

  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Ipilimumab

Study Locations (13)

Massachusetts

  • Massachusetts General Hospital Cancer Center - Boston
  • Beth Israel Deaconess Medical Center - Boston
  • Dana-Farber Cancer Institute - Boston
  • Massachusetts General Hospital - Charlestown

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • UC San Diego Moores Cancer Center - La Jolla
  • City of Hope South Pasadena - South Pasadena

Florida

  • Moffitt Cancer Center-International Plaza - Tampa
  • Moffitt Cancer Center - Tampa

Maine

  • Eastern Maine Medical Center - Bangor
  • Lafayette Family Cancer Center-EMMC - Brewer

Colorado

  • Colorado Blood Cancer Institute - Denver

Georgia

  • Northside Hospital - Atlanta

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2013-05-16
Est. Completion 2021-06-10
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01822509 record still lists

NCT01822509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, above the 57-participant average among 57 other Recurrent Acute Myeloid Leukemia trials with a reported enrollment target (25% higher).

The record links to 10 conditions, with Recurrent Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT01822509 lists 13 locations in 6 states (Massachusetts, California, Florida).

Frequently Asked Questions

What is clinical trial NCT01822509 about?

NCT01822509 is a clinical study titled "Ipilimumab or Nivolumab in Treating Patients With Relapsed Hematologic Malignancies After Donor Stem Cell Transplant". This phase I/Ib trial studies the side effects and best dose of ipilimumab or nivolumab in treating patients with cancers of the blood and blood-forming tissues (hematologic cancers) that have returned after a period of improvement (relapsed) after donor stem cell transplant. Immunotherapy with mono...

What is the current status of trial NCT01822509?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2013-05-16. Estimated completion is 2021-06-10.

What conditions does trial NCT01822509 study?

This clinical trial studies the following conditions: Recurrent Acute Myeloid Leukemia, Myeloproliferative Neoplasm, Recurrent Chronic Lymphocytic Leukemia, Recurrent Myelodysplastic Syndrome, Recurrent Acute Lymphoblastic Leukemia.

What interventions are being tested in trial NCT01822509?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01822509?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01822509 being conducted?

This trial has 13 study locations across California, Colorado, Florida, Georgia, Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Recurrent Acute Myeloid 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 NCT01822509's enrollment target sits among peer trials

71 16th of 57 higher than 42 of 57 other Recurrent Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Acute Myeloid 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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Related registry views

Source: ClinicalTrials.gov NCT01822509, the US trial registry maintained by the National Library of Medicine. NCT01822509 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.