Condition or disease | Intervention/treatment | Phase |
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Leukemia | Biological: CIML NK Drug: Fludarabine Drug: Cyclophosphamide | Phase 1 |
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.
The U.S. Food and Drug Administration (FDA) has not approved CIML NK Cell Infusion as a treatment for relapsed disease.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Trial of CIML NK Cell Infusion for Myeloid Disease Relapse After Haploidentical Hematopoietic Cell Transplantation |
Actual Study Start Date : | August 31, 2019 |
Estimated Primary Completion Date : | April 2, 2025 |
Estimated Study Completion Date : | February 15, 2026 |
Arm | Intervention/treatment |
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Experimental: CIML NK
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Biological: CIML NK
CIML NK cells have enhanced ability to recognize and kill leukemia targets
Drug: Fludarabine Fludarabine is a chemotherapy drug Chemotherapy is most effective at killing cells that are rapidly dividing.
Drug: Cyclophosphamide Cyclophosphamide (CP), also known as cytophosphane among other names, is a medication used as chemotherapy and to suppress the immune system.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function as defined below:
Exclusion Criteria:
Contact: Rizwan Romee, MD | 617-632-3470 | Rizwan_romee@dfci.harvard.edu |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Rizwan Romee, MD 617-632-4422 Rizwan_romee@dfci.harvard.edu | |
Principal Investigator: Rizwan Romee, MD |
Principal Investigator: | Rizwan Romee, MD | Dana-Farber Cancer Institute |
Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | July 17, 2019 | ||||||||||||||
First Posted Date ICMJE | July 18, 2019 | ||||||||||||||
Last Update Posted Date | December 8, 2020 | ||||||||||||||
Actual Study Start Date ICMJE | August 31, 2019 | ||||||||||||||
Estimated Primary Completion Date | April 2, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Safety (DLT by 6 weeks) [ Time Frame: 6 Weeks ] We will assess dose limiting toxicity of this treatment.
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Original Primary Outcome Measures ICMJE |
The maximum tolerated dose [ Time Frame: 2 years ] | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | A Phase 1 Trial of CIML NK Cell Infusion for Myeloid Disease Relapse After Haploidentical Hematopoietic Cell Transplantation | ||||||||||||||
Official Title ICMJE | A Phase 1 Trial of CIML NK Cell Infusion for Myeloid Disease Relapse After Haploidentical Hematopoietic Cell Transplantation | ||||||||||||||
Brief Summary | This research study is is studying cytokine induced memory-like natural killer (CIML NK) cells plus IL-2 in Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Myeloproliferative Neoplasms (MPN. | ||||||||||||||
Detailed Description |
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied. The U.S. Food and Drug Administration (FDA) has not approved CIML NK Cell Infusion as a treatment for relapsed disease. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 1 | ||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Leukemia | ||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: CIML NK
Interventions:
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE |
20 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | February 15, 2026 | ||||||||||||||
Estimated Primary Completion Date | April 2, 2025 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04024761 | ||||||||||||||
Other Study ID Numbers ICMJE | 19-265 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Rizwan Romee, Dana-Farber Cancer Institute | ||||||||||||||
Study Sponsor ICMJE | Rizwan Romee | ||||||||||||||
Collaborators ICMJE | The Leukemia and Lymphoma Society | ||||||||||||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||||
Verification Date | December 2020 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |