Ibrutinib in Preventing Acute Leukemia in Patients After Reduced-Intensity Conditioning and Stem Cell Transplant

NCT03267186 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB-38934NCI-2017-00125BMT302
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well ibrutinib works in preventing acute leukemia in patients after reduced-intensity conditioning and stem cell transplant. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Acute Biphenotypic Leukemia; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic Cell Transplantation Recipient

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Relapsed Leukemia

  Relapsed leukemia is defined as \> 5% leukemic blasts detected in bone marrow or peripheral blood. Participants were also be considered to have relapsed leukemia if they receive any active treatment for progressive leukemia after allogeneic HCT, even if they have \< 5% leukemic blasts. Withdrawal of immunosuppression alone is not considered an active treatment for progressive disease.

  Up to 18 months

Secondary Outcomes (3)

• Number of Participants With Acute Graft-versus-host Disease (GVHD) (Any Grade)

  At 180 days

• Number of Participants With Chronic GVHD

  At 18 months

• Number of Participants Negative for Detectable Minimal Residual Disease

  day +90, day +180, 1 year, 1.5 years

Study Arms (1)

Prevention (ibrutinib)

EXPERIMENTAL

Beginning 60-90 days after allogeneic HCT, patients receive ibrutinib PO QD for up to 18 months post-transplant in the absence of disease progression or unacceptable toxicity.

Drug: Ibrutinib; Other: Laboratory Biomarker Analysis

Interventions

Ibrutinib DRUG

Given PO

Also known as: BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765

Prevention (ibrutinib)

Laboratory Biomarker Analysis OTHER

Correlative studies

Prevention (ibrutinib)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of acute myeloid leukemia (AML), acute biphenotypic leukemia, or acute lymphoblastic leukemia (ALL); CML transformed to blast crisis is eligible
• Planned allogeneic HCT using fludarabine phosphate (FLU)/melphalan hydrochloride (MEL) or FLU/busulfan (BU) conditioning
• Planned graft versus host disease (GVHD) prophylaxis consisting of tacrolimus (TAC)/methotrexate (MTX) or TAC/sirolimus (SRL)
• Human leukocyte antigen (HLA) identical sibling donor, HLA matched unrelated donor, or donor mismatched at 1 HLA allele or antigen
• Less than or equal to 5% blasts on bone marrow examination within 60 days of starting conditioning
• Age \>= 18 years and =\< 70 years
• Able to give informed consent
• Subjects will be eligible if their planned conditioning regimen for allogeneic HCT consists of one of the two following standard reduced intensity conditioning regimens:
• FLU/MEL: fludarabine phosphate (fludarabine) 120 to 180 mg/m\^2; melphalan hydrochloride (melphalan) =\< 150 mg/m\^2
• FLU/BU: fludarabine 120 to 180 mg/m\^2; busulfan =\< 8 mg/kg orally or =\< 6.4 mg/kg intravenously
• Subjects will be eligible if their planned post grafting immunosuppression consists of one of the two following regimens:
• TAC/MTX: tacrolimus (oral or intravenous) and intravenous methotrexate administered according to institutional standard practice.
• TAC/SRL: tacrolimus (oral or intravenous) and oral sirolimus, administered according to institutional standards of care
• Age \>= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2

You may not qualify if:

• Malignancy treated with curative intent and with no known active disease present for \>= 3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in situ without evidence of disease

Sponsors & Collaborators

• Andrew Rezvani: lead
• National Institutes of Health (NIH): collaborator
• Pharmacyclics LLC.: collaborator

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• Jagasia MH, Greinix HT, Arora M, Williams KM, Wolff D, Cowen EW, Palmer J, Weisdorf D, Treister NS, Cheng GS, Kerr H, Stratton P, Duarte RF, McDonald GB, Inamoto Y, Vigorito A, Arai S, Datiles MB, Jacobsohn D, Heller T, Kitko CL, Mitchell SA, Martin PJ, Shulman H, Wu RS, Cutler CS, Vogelsang GB, Lee SJ, Pavletic SZ, Flowers ME. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015 Mar;21(3):389-401.e1. doi: 10.1016/j.bbmt.2014.12.001. Epub 2014 Dec 18.

  PMID: 25529383 BACKGROUND

MeSH Terms

Conditions

Leukemia, Biphenotypic, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study did not enroll the planned number of participants and did not achieve statistical power.

Results Point of Contact

• Title: Andrew R. Rezvani, MD
• Organization: Stanford University

arezvani@stanford.edu

650-725-4077

Study Officials

• Andrew Rezvani

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: August 30, 2017
• Study Start: September 12, 2017
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)