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Trial record 10 of 19 for:    arog

Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients

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ClinicalTrials.gov Identifier: NCT02400255
Recruitment Status : Recruiting
First Posted : March 27, 2015
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Arog Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE March 18, 2015
First Posted Date  ICMJE March 27, 2015
Last Update Posted Date December 6, 2019
Actual Study Start Date  ICMJE September 2015
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
progression-free survival (PFS) [ Time Frame: 2 years ]
PFS, defined as the time to disease progression or death, whichever occurs first, starting when crenolanib administration is begun.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02400255 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
  • disease-free survival (DFS) [ Time Frame: 2 years ]
  • overall survival (OS) [ Time Frame: 2 years ]
  • graft-versus-host disease [ Time Frame: 2 years ]
  • 100-day transplant-related mortality [ Time Frame: 4 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients
Official Title  ICMJE A Phase II Study of Crenolanib Besylate Maintenance Following Allogeneic Stem Cell Transplantation in Patients With FLT3-positive Acute Myeloid Leukemia
Brief Summary This is a single-arm, Phase II study of crenolanib as maintenance in AML patients with FLT3 mutations who have achieved complete remission (CR) after allogeneic stem cell transplantation. Oral crenolanib will be administered daily post-transplant for up to two years.
Detailed Description There are two patient subgroups: 1) those who were in complete remission (CR) at the time of transplant, and 2) those who were not in complete remission (NCR) at the time of transplant. Start of crenolanib therapy at 100 mg TID is intended at the earliest time no sooner than 30 days but no later than 90 days after allogeneic stem cell transplantation. Patients may take crenolanib continuously for up to 728 days or until one of the criteria for study discontinuation is fulfilled.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE Drug: Crenolanib besylate
Other Name: CP-868,596-26
Study Arms  ICMJE
  • Experimental: Cohort A
    Cohort A will include patients who underwent allogeneic hematopoietic stem cell transplantation (HSCT) while in first or second complete remission with count recovery. Crenolanib besylate maintenance therapy will start at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
    Intervention: Drug: Crenolanib besylate
  • Experimental: Cohort B
    Cohort B will include patients who underwent HSCT with incomplete count recovery although they had ≤%10 bone marrow blasts at the time of HSCT. Crenolanib besylate maintenance therapy will start at the earliest time no sooner than 45 days but no later than 90 days after allogeneic HSCT.
    Intervention: Drug: Crenolanib besylate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2015)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. History of AML according to World Health Organization (WHO) classification
  2. First allogeneic hematopoietic stem cell transplantation (HSCT) using myeloablative conditioning (MAC), non-myeloablative (NMA), or reduced-intensity conditioning (RIC) preparative regimens.
  3. FLT3-ITD or FLT3-D835 positive disease at any time during disease course.
  4. Hematopoietic stem cell source is either with peripheral blood, bone marrow or cord blood.
  5. Donor source is matched related, unrelated, haploidentical donor or cord blood.
  6. At the time of allogeneic HSCT:

    1. No more than 1 antigen mismatch at HLA-A, -B, -C, -DRB1 or -DQB1 locus for unrelated donor with peripheral blood and bone marrow as the hematopoietic stem cell source; and
    2. Bone marrow blast ≤ 10%
  7. No sooner than 45 days but no later than 90 days after allogeneic HSCT.
  8. Post-transplant bone marrow blast count ≤ 5% confirmed by standard of care bone marrow biopsy performed post-transplant (at least 30 days post-transplant).
  9. Evidence of donor engraftment as defined by institutional standard T cell chimerism > 50%.
  10. Adequate engraftment within 7 days prior to starting study therapy: ANC ≥ 1.0 x 109/L without daily use of myeloid growth factor; and platelet ≥ 25 x 109/L without platelet transfusion within 1 week
  11. Non-hematological toxicities ≤ Grade 2
  12. Serum creatinine ≤ 1.5 × ULN OR creatinine clearance ≥ 50mL/min/1.73 m2 for subjects with creatinine levels above institutional normal
  13. Adequate liver function with serum AST, ALT and bilirubin within the normal range at the time of crenolanib commencement
  14. Acute graft-versus-host disease (GVHD) ≤ Grade 1, either no signs of chronic GVHD or mild chronic GVHD graded as limited disease
  15. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  16. Age ≥ 18 years with the capacity to give written informed consent
  17. Non-pregnant and non-nursing women of childbearing potential must have a negative serum or urine pregnancy test ("Women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months)
  18. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 90 days following completion of therapy

Exclusion Criteria:

  1. Active GVHD grade ≥ 2
  2. Concurrent use of corticosteroids equivalent of prednisone at a dose > 0.5 mg/kg
  3. Active and/or untreated central nervous system (CNS) leukemia
  4. Concomitant therapies for treatment or control of leukemia.
  5. Use of any of the following after transplantation and prior to starting study therapy:

    1. Chemotherapeutic agents for therapy of AML (note that prophylactic use of these agents is allowed in this study, e.g., methotrexate for GVHD)
    2. Investigational agents/therapies
    3. Azacitidine, decitabine or other demethylating agents
    4. Lenalidomide, thalidomide and pomalidomide
  6. Uncontrolled infection
  7. Known positive for human immunodeficiency virus (HIV); active hepatitis B (HBV) or hepatitis C (HCV) infection
  8. Significant cardiac disease (New York Heart Association classes III or IV) or unstable angina despite medication
  9. Pregnant or breast-feeding
  10. Receipt of investigational agents within 5 half-lives of last dose of investigational agent
  11. Prior treatment with crenolanib with progression on treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vinoo Urity 214-593-0521 vurity@arogpharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02400255
Other Study ID Numbers  ICMJE ARO-009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arog Pharmaceuticals, Inc.
Study Sponsor  ICMJE Arog Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Champlin, MD M.D. Anderson Cancer Center
PRS Account Arog Pharmaceuticals, Inc.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP