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NLA101 in Adults Receiving High Dose Chemotherapy for AML (LAUNCH)

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ClinicalTrials.gov Identifier: NCT03301597
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Nohla Therapeutics, Inc.

Brief Summary:
Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of NLA101 to reduce the rate of infections associated with CIN in adult subjects with AML.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Biological: NLA101 Drug: Standard of Care (SOC) chemotherapy Phase 2

Detailed Description:

Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of NLA101 to reduce the rate of infections associated with chemotherapy induced neutropenia (CIN) in adult subjects with AML.

Eligible subjects with untreated de novo or secondary AML and per local institutional standards planned to receive at least two cycles of chemotherapy with curative intent will be enrolled into the study and randomized 1:1:1:1 to 1 of 3 Investigational Arms (Standard of Care [SOC] chemotherapy + low, medium, or high dose NLA101) or a Control Arm (SOC chemotherapy).

Subjects randomized to an Investigational Arm will be eligible to receive a single fixed assigned dose of NLA101 after the first cycle of chemotherapy, and up to 2 additional identical cell doses after subsequent chemotherapy cycles (one NLA101 infusion per cycle). Subjects randomized to the Control Arm will be followed for up to 3 cycles of chemotherapy.

All subjects will be followed for 84 days following randomization, or 30 days post final infusion of NLA101, or 30 days post the day after the last chemotherapy infusion for Control Arm, whichever is longer.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to 1 of 3 Investigational Arms or a Control Arm in a 1:1:1:1 ratio.
Masking: Single (Outcomes Assessor)
Masking Description: This is an open-label study.
Primary Purpose: Prevention
Official Title: A Phase 2 Open-Label, Multi-Center, Randomized, Controlled, Dose-Finding Study of NLA101 in Adults Receiving High Dose Chemotherapy for Acute Myeloid Leukemia
Actual Study Start Date : January 24, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019


Arm Intervention/treatment
Control Arm
The Control Arm will receive standard of care (SOC) chemotherapy without the infusion of NLA101. SOC chemotherapy will be determined by local PI and must be a standard regimen for untreated de novo or secondary AML that will result in moderate to severe myelosuppression and will be given with curative intent.
Drug: Standard of Care (SOC) chemotherapy
The SOC chemotherapy regimen for each patient will be determined by local PI. Regimen must be a standard AML regimen that will result in moderate to severe myelosuppression and have curative intent.

Experimental: Low Dose Arm
The Low Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of low-dose NLA101.
Biological: NLA101
NLA101 is a universal donor "off-the-shelf" ex-vivo expanded hematopoietic stem and progenitor cell (HSPC) product that is cryopreserved and ready for immediate use.
Other Name: Dilanubicel

Drug: Standard of Care (SOC) chemotherapy
The SOC chemotherapy regimen for each patient will be determined by local PI. Regimen must be a standard AML regimen that will result in moderate to severe myelosuppression and have curative intent.

Experimental: Medium Dose Arm
The Medium Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of medium-dose NLA101.
Biological: NLA101
NLA101 is a universal donor "off-the-shelf" ex-vivo expanded hematopoietic stem and progenitor cell (HSPC) product that is cryopreserved and ready for immediate use.
Other Name: Dilanubicel

Drug: Standard of Care (SOC) chemotherapy
The SOC chemotherapy regimen for each patient will be determined by local PI. Regimen must be a standard AML regimen that will result in moderate to severe myelosuppression and have curative intent.

Experimental: High Dose Arm
The High Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of high-dose NLA101.
Biological: NLA101
NLA101 is a universal donor "off-the-shelf" ex-vivo expanded hematopoietic stem and progenitor cell (HSPC) product that is cryopreserved and ready for immediate use.
Other Name: Dilanubicel

Drug: Standard of Care (SOC) chemotherapy
The SOC chemotherapy regimen for each patient will be determined by local PI. Regimen must be a standard AML regimen that will result in moderate to severe myelosuppression and have curative intent.




Primary Outcome Measures :
  1. Recurrent Event Rate of Grade 3 or Higher Bacterial or Fungal Infection [ Time Frame: From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later ]

Secondary Outcome Measures :
  1. Event rate of grade 3 or higher documented bacterial and fungal infections per cycle of chemotherapy [ Time Frame: From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later ]
  2. Incidence and duration of filgrastim (or biosimilar) administration [ Time Frame: From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later ]
  3. Overall Response Rate [ Time Frame: From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later ]
  4. Incidence and duration of complications due to infections [ Time Frame: From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later ]
  5. Incidence and duration of grade 3 or higher fever or hypothermia [ Time Frame: From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Criteria:

Inclusion Criteria:

  • Age ≥ 18 (or legal age of majority for sites outside US).
  • Untreated de novo or secondary acute myeloid leukemia (AML), including AML that has progressed from myelodysplastic syndrome (MDS), and histologically documented diagnosis
  • Eligible for at least 2 cycles of standard of care AML chemotherapy that will result in moderate to severe myelosuppression and have curative intent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 or Karnofsky Status of 50 to 100.
  • Adequate cardiac, renal, and hepatic functions.

Exclusion Criteria:

  • Extramedullary disease in the absence of bone marrow or blood involvement
  • Acute promyelocytic leukemia (APL) with PML-RARA
  • Prior AML therapy, with the exception of intrathecal chemotherapy or emergent radiation for myeloid sarcoma.
  • Concurrent malignancy requiring active treatment with chemotherapy, immunotherapy, or radiation
  • Prior allotransplant, including allogeneic hematopoietic cell transplant or solid organ allogeneic transplant
  • Known hypersensitivity or history of hypersensitivity to dimethylsulfoxide (DMSO)
  • Active/chronic human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301597


Contacts
Contact: Richie Phan, CTM 206-519-5318 RichieP@NohlaTherapeutics.com

  Show 33 Study Locations
Sponsors and Collaborators
Nohla Therapeutics, Inc.
Investigators
Study Chair: Martin S Tallman, MD Memorial Sloan Kettering Cancer Center
Study Chair: Naval G Daver, MD M.D. Anderson Cancer Center

Responsible Party: Nohla Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03301597     History of Changes
Other Study ID Numbers: NLA-0101-CIN-01
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nohla Therapeutics, Inc.:
Chemotherapy-induced Neutropenia
Bacterial Infections
Fungal Infections

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms