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

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01822509
Phase
PHASE1
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
May 16, 2013
Status verified
Jun 2021
Primary completion
Dec 31, 2018
Completion
Jun 10, 2021

Study Design

Enrollment
71 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ipilimumab, nivolumab)
    See Detailed Description.

Primary Outcome Measure

Maximum tolerated dose (MTD) of ipilimumab according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Phase I) [ Time Frame: At 12 weeks ]

Locations (13)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
City of Hope South PasadenaSouth PasadenaCalifornia91030-
Colorado Blood Cancer InstituteDenverColorado80218-
Moffitt Cancer CenterTampaFlorida33612-
Moffitt Cancer Center-International PlazaTampaFlorida33607-
Northside HospitalAtlantaGeorgia30342-
Eastern Maine Medical CenterBangorMaine04401-
Lafayette Family Cancer Center-EMMCBrewerMaine04412-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Massachusetts General HospitalCharlestownMassachusetts02129-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUC San Diego Moores Cancer Center· La Jolla, CACity of Hope South Pasadena· South Pasadena, CAColorado Blood Cancer Institute· Denver, COMoffitt Cancer Center· Tampa, FLMoffitt Cancer Center-International Plaza· Tampa, FL

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